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idK150617_s0_e2000 | K150617.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualita... |
idK150617_s0_e2000 | K150617.txt | product code | OQO | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualita... |
idK150617_s0_e2000 | K150617.txt | panel | Microbiology (83) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualit... |
idK150617_s0_e2000 | K150617.txt | predicate device name | BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative ... |
idK150617_s0_e2000 | K150617.txt | applicant | Roche Molecular Systems, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualita... |
idK150617_s0_e2000 | K150617.txt | proprietary and established names | cobas® HSV 1 and 2 Test | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative detec... |
idK150617_s0_e2000 | K150617.txt | regulation section | 21 CFR 866.3305 | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitat... |
idK150617_s14000_e16000 | K150617.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK150617_s14000_e16000 | K150617.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK143736_s0_e2000 | K143736.txt | purpose for submission | New device | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and... |
idK143736_s0_e2000 | K143736.txt | measurand | Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and... |
idK143736_s0_e2000 | K143736.txt | type of test | Immunoassay, qualitative and semi-quantitative | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary... |
idK143736_s0_e2000 | K143736.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietar... |
idK143736_s0_e2000 | K143736.txt | product code | DHR: System, Test, Rheumatoid Factor | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietar... |
idK143736_s0_e2000 | K143736.txt | panel | Immunology (82) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprieta... |
idK143736_s0_e2000 | K143736.txt | applicant | IMMCO Diagnostics, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietar... |
idK143736_s0_e2000 | K143736.txt | regulation section | 21 CFR §866.5775: Rheumatoid factor immunological test system | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary... |
idK143736_s10000_e12000 | K143736.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | CI: 87.6%–94.8% Overall Percent Agreement 90.9% 95% CI: 87.8%–93.2% n = 184 Rheumatoid Arthr... |
idK143736_s10000_e12000 | K143736.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | 95% CI: 87.6%–94.8% Overall Percent Agreement 90.9% 95% CI: 87.8%–93.2% n = 184 Rheumatoid A... |
idK181889_s0_e2000 | K181889.txt | purpose for submission | To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms | SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL ... |
idK181889_s0_e2000 | K181889.txt | measurand | Penicillin 0.002-32 μg/mL | SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL ... |
idK181889_s0_e2000 | K181889.txt | type of test | Quantitative Antimicrobial Susceptibility Test growth-based detection | ) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL... |
idK181889_s0_e2000 | K181889.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/m... |
idK181889_s0_e2000 | K181889.txt | product code | JWY - Manual Antimicrobial Susceptibility Test Systems | k) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/m... |
idK181889_s0_e2000 | K181889.txt | panel | 83 – Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/... |
idK181889_s0_e2000 | K181889.txt | predicate device name | Liofilchem MTS, vancomycin | SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL ... |
idK181889_s0_e2000 | K181889.txt | applicant | Liofilchem s.r.l. | k) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/m... |
idK181889_s0_e2000 | K181889.txt | proprietary and established names | MTS Penicillin 0.002-32 μg/mL | ANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Typ... |
idK181889_s0_e2000 | K181889.txt | regulation section | 866.1640 Antimicrobial Susceptibility Test Powder | ) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL... |
idK181889_s2000_e4000 | K181889.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | limit: Not Applicable e. Analytical specificity: Not Applicable f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: The MTS, Penicillin was evaluated at three sites located within the United States. Each clinical isolate was tested one time by MTS, Penicillin and the ref... |
idK181379_s0_e2000 | K181379.txt | purpose for submission | To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzym... |
idK181379_s0_e2000 | K181379.txt | measurand | H. pylori antigen | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzym... |
idK181379_s0_e2000 | K181379.txt | type of test | Qualitative membrane enzyme immunoassay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzy... |
idK181379_s0_e2000 | K181379.txt | classification | Class I | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enz... |
idK181379_s0_e2000 | K181379.txt | product code | LYR-– Campylobacter pylori | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enz... |
idK181379_s0_e2000 | K181379.txt | panel | 83-Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane en... |
idK181379_s0_e2000 | K181379.txt | predicate device name | ImmunoCard STAT! HpSA | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzym... |
idK181379_s0_e2000 | K181379.txt | applicant | TechLab Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enz... |
idK181379_s0_e2000 | K181379.txt | proprietary and established names | H. PYLORI QUIK CHEK | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immu... |
idK181379_s0_e2000 | K181379.txt | regulation section | 21 CFR 866.3110 Campylobacter fetus serological reagents | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzy... |
idK181379_s4000_e6000 | K181379.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK181379_s4000_e6000 | K181379.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK162333_s0_e2000 | K162333.txt | purpose for submission | Clearance of a new device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established N... |
idK162333_s0_e2000 | K162333.txt | measurand | Human hemoglobin (hHb) in feces | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established N... |
idK162333_s0_e2000 | K162333.txt | type of test | Lateral flow chromatographic immunoassay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established ... |
idK162333_s0_e2000 | K162333.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established... |
idK162333_s0_e2000 | K162333.txt | product code | KHE, Reagent, Occult Blood | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established... |
idK162333_s0_e2000 | K162333.txt | panel | Hematology (81) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Establishe... |
idK162333_s0_e2000 | K162333.txt | indications for use | Same as Intended Use | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established N... |
idK162333_s0_e2000 | K162333.txt | predicate device name | FOB One Step Rapid Test (Orient Gene Biotech) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established N... |
idK162333_s0_e2000 | K162333.txt | applicant | Guangzhou Wondfo Biotech Co., Ltd. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established... |
idK162333_s0_e2000 | K162333.txt | proprietary and established names | Wondfo One Step Fecal Occult Blood Test | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: ... |
idK162333_s0_e2000 | K162333.txt | regulation section | 21 CFR 864.6550, Occult blood test | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established ... |
idK162333_s6000_e8000 | K162333.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | Test Positive Negative Total POC Site 1 Positive 35 0 35 100% 100% (90.1%-100%) 100% (96.3%-100%) Negative 0 101 101 Total 35 101 136 POC Site 2 Positive 45 0 45 99.3% 97.8% (88.7%-99.6%) 100% (96.3%-100%) Negative 1 101 102 Total 46 101 147 POC Site 3 Positive 52 1 53 99.6%... |
idK162333_s6000_e8000 | K162333.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | Step Rapid Test Positive Negative Total POC Site 1 Positive 35 0 35 100% 100% (90.1%-100%) 100% (96.3%-100%) Negative 0 101 101 Total 35 101 136 POC Site 2 Positive 45 0 45 99.3% 97.8% (88.7%-99.6%) 100% (96.3%-100%) Negative 1 101 102 Total 46 101 147 POC Site 3 Positive 52... |
idK181700_s0_e2000 | K181700.txt | purpose for submission | Addition of Plazomicin Antimicrobial Susceptibility Test Disk | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprie... |
idK181700_s0_e2000 | K181700.txt | measurand | Plazomicin 30µg | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprie... |
idK181700_s0_e2000 | K181700.txt | type of test | Antimicrobial Susceptibility Test Disks | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Propri... |
idK181700_s0_e2000 | K181700.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Propr... |
idK181700_s0_e2000 | K181700.txt | product code | JTN | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Propr... |
idK181700_s0_e2000 | K181700.txt | panel | 83, Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Prop... |
idK181700_s0_e2000 | K181700.txt | intended use | HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomona... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Propri... |
idK181700_s0_e2000 | K181700.txt | predicate device name | HardyDisk Tigecycline 15µg | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprie... |
idK181700_s0_e2000 | K181700.txt | applicant | Hardy Diagnostics | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Propr... |
idK181700_s0_e2000 | K181700.txt | proprietary and established names | HardyDisk AST Plazomicin 30µg (PLZ30) | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary a... |
idK181700_s0_e2000 | K181700.txt | regulation section | 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Propri... |
idK181700_s2000_e4000 | K181700.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK181700_s2000_e4000 | K181700.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK150281_s0_e2000 | K150281.txt | purpose for submission | Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood gluco... |
idK150281_s0_e2000 | K150281.txt | measurand | Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood gluco... |
idK150281_s0_e2000 | K150281.txt | type of test | Quantitative amperometric assay, glucose oxidase | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood g... |
idK150281_s0_e2000 | K150281.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood ... |
idK150281_s0_e2000 | K150281.txt | product code | CGA, Glucose Oxidase, Glucose | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood ... |
idK150281_s0_e2000 | K150281.txt | panel | Clinical Chemistry (75) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood... |
idK150281_s0_e2000 | K150281.txt | intended use | See Indications for Use below. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood g... |
idK150281_s0_e2000 | K150281.txt | predicate device name | Nova StatStrip Glucose Hospital Meter System | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood gluco... |
idK150281_s0_e2000 | K150281.txt | applicant | Nova Biomedical Corporation | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood ... |
idK150281_s0_e2000 | K150281.txt | proprietary and established names | StatStrip Glucose Hospital Meter System | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, v... |
idK150281_s0_e2000 | K150281.txt | regulation section | 21 CFR 862.1345, Glucose test system | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood g... |
idK150281_s2000_e4000 | K150281.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK150281_s2000_e4000 | K150281.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK182353_s0_e2000 | K182353.txt | purpose for submission | Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 7... |
idK182353_s0_e2000 | K182353.txt | measurand | IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 7... |
idK182353_s0_e2000 | K182353.txt | type of test | Automated semi-quantitative solid-phase fluoroimmunoassays | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein ... |
idK182353_s0_e2000 | K182353.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein... |
idK182353_s0_e2000 | K182353.txt | panel | Immunology (82) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotei... |
idK182353_s0_e2000 | K182353.txt | indications for use | Same as Intended Uses | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 7... |
idK182353_s0_e2000 | K182353.txt | predicate device name | EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 7... |
idK182353_s0_e2000 | K182353.txt | applicant | Phadia AB | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein... |
idK182353_s0_e2000 | K182353.txt | proprietary and established names | EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (... |
idK182353_s8000_e10000 | K182353.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK170491_s0_e2000 | K170491.txt | purpose for submission | To obtain a substantial equivalence determination for a new device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Depen... |
idK170491_s0_e2000 | K170491.txt | measurand | tcdA gene of toxigenic Clostridium difficile | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Depen... |
idK170491_s0_e2000 | K170491.txt | type of test | Qualitative Helicase-Dependent Amplification (HDA) assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Depe... |
idK170491_s0_e2000 | K170491.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dep... |
idK170491_s0_e2000 | K170491.txt | product code | OZN | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dep... |
idK170491_s0_e2000 | K170491.txt | panel | Microbiology (83) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-De... |
idK170491_s0_e2000 | K170491.txt | intended use | The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis ... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Depe... |
idK170491_s0_e2000 | K170491.txt | predicate device name | Portrait Toxigenic C. difficile Assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Depen... |
idK170491_s0_e2000 | K170491.txt | applicant | Quidel Corporation | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dep... |
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