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idK173829_s0_e2000 | K173829.txt | purpose for submission | New device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDUA)... |
idK173829_s0_e2000 | K173829.txt | measurand | Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDUA) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDUA)... |
idK173829_s0_e2000 | K173829.txt | type of test | Quantitative mass spectrometric enzymatic activity assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDUA... |
idK173829_s0_e2000 | K173829.txt | classification | II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDU... |
idK173829_s0_e2000 | K173829.txt | panel | Chemistry (75) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (ID... |
idK173829_s0_e2000 | K173829.txt | intended use | See Indication(s) for use. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDUA... |
idK173829_s0_e2000 | K173829.txt | predicate device name | SEEKER System | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDUA)... |
idK173829_s0_e2000 | K173829.txt | applicant | Wallac Oy, a subsidiary of PerkinElmer | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDU... |
idK173829_s0_e2000 | K173829.txt | proprietary and established names | NeoLSD MSMS kit | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDUA) D. Ty... |
idK173829_s0_e2000 | K173829.txt | regulation section | 862.1488 Lysosomal storage disorder newborn screening test system | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k173829 B. Purpose for Submission: New device C. Measurand: Acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), α-L-iduronidase (IDUA... |
idK173829_s8000_e10000 | K173829.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable and the special controls for this device type under 21 CFR 862.1488. | ... |
idK173829_s8000_e10000 | K173829.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK160538_s0_e2000 | K160538.txt | purpose for submission | Clearance of a new device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160538 B. Purpose for Submission: Clearance of a new device C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The XN-L analyzer classifies and enumerates the foll... |
idK160538_s0_e2000 | K160538.txt | type of test | The XN-L analyzer classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, P... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160538 B. Purpose for Submission: Clearance of a new device C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The XN-L analyzer classifies and enumerates the ... |
idK160538_s0_e2000 | K160538.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160538 B. Purpose for Submission: Clearance of a new device C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The XN-L analyzer classifies and enumerates the... |
idK160538_s0_e2000 | K160538.txt | product code | GKZ, Counter, differential cell | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160538 B. Purpose for Submission: Clearance of a new device C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The XN-L analyzer classifies and enumerates the... |
idK160538_s0_e2000 | K160538.txt | panel | Hematology (81) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160538 B. Purpose for Submission: Clearance of a new device C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The XN-L analyzer classifies and enumerates th... |
idK160538_s0_e2000 | K160538.txt | predicate device name | Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzer | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160538 B. Purpose for Submission: Clearance of a new device C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The XN-L analyzer classifies and enumerates the foll... |
idK160538_s0_e2000 | K160538.txt | applicant | Sysmex America Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160538 B. Purpose for Submission: Clearance of a new device C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The XN-L analyzer classifies and enumerates the... |
idK160538_s0_e2000 | K160538.txt | regulation section | 21 CFR 864.5220, Automated differential cell counter | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160538 B. Purpose for Submission: Clearance of a new device C. Manufacturer and Instrument Name: Sysmex America Inc., Sysmex® XN-L Automated Hematology Analyzer D. Type of Test or Tests Performed: The XN-L analyzer classifies and enumerates the ... |
idK160538_s18000_e20000 | K160538.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK160538_s18000_e20000 | K160538.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK161714_s0_e2000 | K161714.txt | purpose for submission | New device | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k161714 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. E. Applicant: Immunalysis Corporation F. Proprietary and Established Name... |
idK161714_s0_e2000 | K161714.txt | measurand | Barbiturates | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k161714 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. E. Applicant: Immunalysis Corporation F. Proprietary and Established Name... |
idK161714_s0_e2000 | K161714.txt | type of test | Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k161714 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. E. Applicant: Immunalysis Corporation F. Proprietary and Established Na... |
idK161714_s0_e2000 | K161714.txt | classification | Class II | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k161714 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. E. Applicant: Immunalysis Corporation F. Proprietary and Establishe... |
idK161714_s0_e2000 | K161714.txt | panel | Toxicology (91) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k161714 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. E. Applicant: Immunalysis Corporation F. Proprietary and Establish... |
idK161714_s0_e2000 | K161714.txt | intended use | Refer to Indications for Use below | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k161714 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. E. Applicant: Immunalysis Corporation F. Proprietary and Established Na... |
idK161714_s0_e2000 | K161714.txt | predicate device name | DRI Barbiturates EIA Assay | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k161714 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. E. Applicant: Immunalysis Corporation F. Proprietary and Established Name... |
idK161714_s0_e2000 | K161714.txt | applicant | Immunalysis Corporation | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k161714 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Homogenous Enzyme Immunoassay, Qualitative and Semi-quantitative. E. Applicant: Immunalysis Corporation F. Proprietary and Establishe... |
idK161714_s4000_e6000 | K161714.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK161714_s4000_e6000 | K161714.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK162688_s0_e2000 | K162688.txt | purpose for submission | To expand the use of previously cleared assay reagents for Coagulation Factor V Deficient Plasma, Coagulation Factor VII Deficient Plasma, Protein C Reagent, and Berichrom® Protein C to the Sysmex® CS-2100i automated blood coagulation analyzer. | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: K162688 B. Purpose for Submission: To expand the use of previously cleared assay reagents for Coagulation Factor V Deficient Plasma, Coagulation Factor VII Deficient Plasma, Protein C Reagent, and Berichrom® Protein C to the Sysmex® CS-2100i autom... |
idK162688_s0_e2000 | K162688.txt | measurand | Factor V activity using Coagulation Factor V Deficient Plasman with Dade® Innovin®; factor VII activity using Coagulation Factor VII Deficient Plasma with Dade® Innovin®; protein C activity using Protein C Reagent and protein C activity using Berichrom® Protein C. All measurands are reported as percent (%)of norm. | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: K162688 B. Purpose for Submission: To expand the use of previously cleared assay reagents for Coagulation Factor V Deficient Plasma, Coagulation Factor VII Deficient Plasma, Protein C Reagent, and Berichrom® Protein C to the Sysmex® CS-2100i autom... |
idK162688_s0_e2000 | K162688.txt | type of test | Factor V activity using Coagulation Factor V with Dade® Innovin®, factor VII activity using Coagulation Factor VII with Dade® Innovin®, and protein C using Protein C Reagent are quantitative clot-based applications. Protein C using Berichrom® Protein C is a quantitative chromogenic application. | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: K162688 B. Purpose for Submission: To expand the use of previously cleared assay reagents for Coagulation Factor V Deficient Plasma, Coagulation Factor VII Deficient Plasma, Protein C Reagent, and Berichrom® Protein C to the Sysmex® CS-2100i aut... |
idK162688_s0_e2000 | K162688.txt | classification | Class II | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: K162688 B. Purpose for Submission: To expand the use of previously cleared assay reagents for Coagulation Factor V Deficient Plasma, Coagulation Factor VII Deficient Plasma, Protein C Reagent, and Berichrom® Protein C to the Sysmex® CS-2100i... |
idK162688_s0_e2000 | K162688.txt | panel | Hematology (81) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: K162688 B. Purpose for Submission: To expand the use of previously cleared assay reagents for Coagulation Factor V Deficient Plasma, Coagulation Factor VII Deficient Plasma, Protein C Reagent, and Berichrom® Protein C to the Sysmex® CS-2100... |
idK162688_s0_e2000 | K162688.txt | predicate device name | Sysmex® Automated Coagulation Analyzer CA-1500 | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: K162688 B. Purpose for Submission: To expand the use of previously cleared assay reagents for Coagulation Factor V Deficient Plasma, Coagulation Factor VII Deficient Plasma, Protein C Reagent, and Berichrom® Protein C to the Sysmex® CS-2100i autom... |
idK162688_s0_e2000 | K162688.txt | applicant | Siemens Healthcare Diagnostics Product GmbH | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: K162688 B. Purpose for Submission: To expand the use of previously cleared assay reagents for Coagulation Factor V Deficient Plasma, Coagulation Factor VII Deficient Plasma, Protein C Reagent, and Berichrom® Protein C to the Sysmex® CS-2100i... |
idK162688_s8000_e10000 | K162688.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK162688_s8000_e10000 | K162688.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK193024_s0_e2000 | K193024.txt | purpose for submission | To obtain a substantial equivalence determination for the addition of Lefamulin to the Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008 – 16 ug/mL | New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pn... |
idK193024_s0_e2000 | K193024.txt | measurand | Lefamulin in the dilution range of 0.008 – 16 μg/mL | New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pn... |
idK193024_s0_e2000 | K193024.txt | type of test | Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection | 03 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influenzae/Streptococcus ... |
idK193024_s0_e2000 | K193024.txt | classification | Class II | 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influenzae/Streptococ... |
idK193024_s0_e2000 | K193024.txt | product code | JWY, LRG, LTT | 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influenzae/Streptococ... |
idK193024_s0_e2000 | K193024.txt | panel | MI - Microbiology | Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influe... |
idK193024_s0_e2000 | K193024.txt | intended use | See Indications for Use below. | 03 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influenzae/Streptococcus ... |
idK193024_s0_e2000 | K193024.txt | applicant | Thermo Fisher Scientific | 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influenzae/Streptococ... |
idK193024_s0_e2000 | K193024.txt | regulation section | 21 CFR 866.1640 - Antimicrobial Susceptibility Test Powder | 03 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: A 510(k) Number K193024 B Applicant Thermo Fisher Scientific C Proprietary and Established Names Sensititre 20-24 hour Haemophilus influenzae/Streptococcus ... |
idK193024_s4000_e6000 | K193024.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK170293_s0_e2000 | K170293.txt | purpose for submission | Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualitati... |
idK170293_s0_e2000 | K170293.txt | measurand | Benzoylecgonine | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualitati... |
idK170293_s0_e2000 | K170293.txt | type of test | Qualitative and semi-quantative homogenous enzyme immunoassay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualitat... |
idK170293_s0_e2000 | K170293.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualita... |
idK170293_s0_e2000 | K170293.txt | product code | DIO – Cocaine and cocaine | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualita... |
idK170293_s0_e2000 | K170293.txt | panel | 91 - Toxicology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualit... |
idK170293_s0_e2000 | K170293.txt | intended use | See indication(s) for use below. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualitat... |
idK170293_s0_e2000 | K170293.txt | predicate device name | Emit II Plus Cocaine Metabolite Assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualitati... |
idK170293_s0_e2000 | K170293.txt | applicant | Siemens Healthcare Diagnostics, Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualita... |
idK170293_s0_e2000 | K170293.txt | proprietary and established names | Emit II Plus Cocaine Metabolite Assay | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170293 B. Purpose for Submission: Adding a previously cleared test (Emit II Plus Cocaine Metabolite Assay) to the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer C. Measurand: Benzoylecgonine D. Type of Test: Qualitative and... |
idK170293_s2000_e4000 | K170293.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK170293_s2000_e4000 | K170293.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK173887_s0_e2000 | K173887.txt | purpose for submission | To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, clinician-collected vaginal swabs, endocervical swabs, male and female urine, and cervical specimens collected in ... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173887 B. Purpose for Submission: To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, clini... |
idK173887_s0_e2000 | K173887.txt | measurand | Chlamydia trachomatis and Neisseria gonorrhoeae DNA | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173887 B. Purpose for Submission: To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, clini... |
idK173887_s0_e2000 | K173887.txt | type of test | Nucleic acid extraction, purification and amplification assay (real-time polymerase chain reaction) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173887 B. Purpose for Submission: To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, clin... |
idK173887_s0_e2000 | K173887.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173887 B. Purpose for Submission: To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, cli... |
idK173887_s0_e2000 | K173887.txt | panel | Microbiology (83) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173887 B. Purpose for Submission: To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, cl... |
idK173887_s0_e2000 | K173887.txt | predicate device name | cobas CT/NG v2.0 Test | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173887 B. Purpose for Submission: To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, clini... |
idK173887_s0_e2000 | K173887.txt | applicant | Roche Molecular Systems, Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173887 B. Purpose for Submission: To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, cli... |
idK173887_s0_e2000 | K173887.txt | regulation section | 21 CFR 866.3390 - Neisseria spp. direct serological test reagents | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173887 B. Purpose for Submission: To determine substantial equivalence for the cobas CT/NG assay for use on the cobas 6800/8800 Systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA from self-collected vaginal swabs, clin... |
idK173887_s28000_e30000 | K173887.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. | ... |
idK173887_s28000_e30000 | K173887.txt | conclusion | 1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK173927_s0_e2000 | K173927.txt | purpose for submission | To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnostics... |
idK173927_s0_e2000 | K173927.txt | measurand | Procalcitonin (PCT) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnostics... |
idK173927_s0_e2000 | K173927.txt | type of test | Quantitative, Electrochemiluminescence Immunoassay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnostic... |
idK173927_s0_e2000 | K173927.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnosti... |
idK173927_s0_e2000 | K173927.txt | product code | PMT | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnosti... |
idK173927_s0_e2000 | K173927.txt | panel | 83 - (Microbiology) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnost... |
idK173927_s0_e2000 | K173927.txt | intended use | Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical ... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnostic... |
idK173927_s0_e2000 | K173927.txt | predicate device name | BRAHMS PCT sensitive KRYPTOR | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnostics... |
idK173927_s0_e2000 | K173927.txt | applicant | Roche Diagnostics | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnosti... |
idK173927_s0_e2000 | K173927.txt | proprietary and established names | Elecsys BRAHMS PCT | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnostics F. Pr... |
idK173927_s0_e2000 | K173927.txt | regulation section | 21 CFR 866.3215; Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K173927 B. Purpose for Submission: To obtain a substantial equivalence determination for the Elecsys BRAHMS PCT. C. Measurand: Procalcitonin (PCT) D. Type of Test: Quantitative, Electrochemiluminescence Immunoassay E. Applicant: Roche Diagnostic... |
idK173927_s6000_e8000 | K173927.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ... |
idK173927_s6000_e8000 | K173927.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK172109_s0_e2000 | K172109.txt | purpose for submission | To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Meas... |
idK172109_s0_e2000 | K172109.txt | measurand | Erythromycin 0.016-256 μg/mL | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Meas... |
idK172109_s0_e2000 | K172109.txt | type of test | Quantitative AST growth based detection | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Mea... |
idK172109_s0_e2000 | K172109.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Me... |
idK172109_s0_e2000 | K172109.txt | product code | JWY - Manual Antimicrobial Test Systems | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Me... |
idK172109_s0_e2000 | K172109.txt | panel | 83 – Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. M... |
idK172109_s0_e2000 | K172109.txt | predicate device name | Liofilchem MTS, vancomycin | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Meas... |
idK172109_s0_e2000 | K172109.txt | applicant | Liofilchem s.r.l. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Me... |
idK172109_s0_e2000 | K172109.txt | proprietary and established names | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016-256 μg/mL | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Measurand:... |
idK172109_s0_e2000 | K172109.txt | regulation section | 866.1640 Antimicrobial Susceptibility Test Powder | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172109 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Erythromycin at concentrations of 0.016 -256 µg/mL for susceptibility testing of Staphylococcus aureus C. Mea... |
idK172109_s2000_e4000 | K172109.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK172109_s2000_e4000 | K172109.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK150617_s0_e2000 | K150617.txt | purpose for submission | Clearance of New Device | 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 | measurand | Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) | 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 ... |
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