FDA Review Panel · MI

FDA 510(k) Microbiology Devices

FDA 510(k) Microbiology Devices - Regulatory Overview

FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.

Key device types:

  • Blood culture systems - automated incubation and detection platforms
  • Microbial identification - MALDI-TOF, biochemical and molecular ID systems
  • Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
  • Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
  • Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens

7061
Total
6999
Cleared
155d
Avg (2y)
1976
Since
4573 Microbiology devices
801–825 of 4573
Cleared Mar 07, 2016
Xpert Carba-R
K152614 · Cepheid
PMY · System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony · 175d
Cleared Feb 25, 2016
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
K160164 · Becton, Dickinson & CO
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 29d
Cleared Feb 25, 2016
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866 · Becton, Dickinson and Company
MDB · System, Blood Culturing · 231d
Cleared Feb 24, 2016
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K160161 · Becton, Dickinson & CO
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 28d
Cleared Feb 18, 2016
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
K151817 · bioMerieux, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 227d
Cleared Jan 15, 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
K151320 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 242d
Cleared Jan 12, 2016
Sofia Influenza A+B FIA
K153012 · Quidel Corporation
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 90d
Cleared Dec 22, 2015
ADVIA Centaur Toxoplasma M (Toxo M)
K142826 · Siemens Healthcare Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 448d
Cleared Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
K152774 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 87d
Cleared Dec 09, 2015
ProParaFlu+ Assay
K153223 · Hologic, Inc.
OOU · Parainfluenza Multiplex Nucleic Acid Assay · 33d
Cleared Dec 03, 2015
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
K151226 · Cepheid
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 210d
Cleared Nov 24, 2015
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
K152846 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 56d
Cleared Nov 24, 2015
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
K152838 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 56d
Cleared Nov 20, 2015
ProFlu+ Assay
K153219 · Hologic, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 15d
Cleared Nov 10, 2015
illumigene Pertussis DNA Amplification Assay
K152285 · Meridian Bioscience, Inc.
OZZ · Bordetella Pertussis Dna Assay System · 90d
Cleared Oct 23, 2015
illumigene Mycoplasma DNA Amplification Assay
K152800 · Meridian Bioscience, Inc.
OZX · Mycoplasma Pneumoniae Dna Assay System · 25d
Cleared Oct 16, 2015
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
K151565 · Cepheid
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 128d
Cleared Oct 13, 2015
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks
K152516 · Becton, Dickinson and Company
JTN · Susceptibility Test Discs, Antimicrobial · 40d
Cleared Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · Beckman Coulter, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 27d
Cleared Aug 28, 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
K150556 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 177d
Cleared Aug 25, 2015
BD MAX Enteric Parasite Panel, BD MAX Instrument
K143648 · Becton, Dickinson and Company
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 246d
Cleared Jul 27, 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
K150236 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 175d
Cleared Jul 17, 2015
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
K151046 · Meridian Bioscience, Inc.
PGI · Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples · 88d
Cleared Jul 02, 2015
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
K150039 · Siemens Healthcare Diagnostics, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 174d
Cleared Jun 23, 2015
Solana GAS Assay, Solana instrument
K150868 · Quidel Corporation
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 83d

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All categories 4573 JWY Manual Antimicrobial Susceptibility Test Systems 361 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 282 JTN Susceptibility Test Discs, Antimicrobial 276 JSJ Culture Media, Selective And Non-differential 232 JSI Culture Media, Selective And Differential 175 JSG Culture Media, Non-selective And Non-differential 168 JTO Discs, Strips And Reagents, Microorganism Differentiation 144 JSH Culture Media, Non-selective And Differential 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 75 GRM Antisera, All Groups, Salmonella Spp. 66 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 62 GTZ Antisera, All Groups, Streptococcus Spp. 59 JSF Culture Media, Single Biochemical Test 58 MDB System, Blood Culturing 54 GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. 51