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
851–875 of 4573
Cleared Aug 19, 2014
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
K133952 · bioMerieux, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 239d
Cleared Aug 05, 2014
VITEK 2 AST - YEAST FLUCONAZOLE
K133817 · bioMerieux, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 232d
Cleared Aug 01, 2014
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
K133847 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 226d
Cleared Jul 25, 2014
LIAISON XL ANALYZER
K141116 · DiaSorin, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 86d
Cleared Jul 24, 2014
AMPLIVUE GAS ASSAY
K141173 · Quidel Corporation
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 79d
Cleared Jul 16, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141000 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 89d
Cleared Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
K141149 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 46d
Cleared Jun 10, 2014
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
K140985 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 55d
Cleared Jun 02, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
K140468 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 97d
Cleared May 20, 2014
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448 · Becton, Dickinson & CO
LSL · Dna-reagents, Neisseria · 88d
Cleared May 20, 2014
BD VIPER LT SYSTEM
K140447 · Becton, Dickinson and Company
OOI · Real Time Nucleic Acid Amplification System · 88d
Cleared May 20, 2014
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K140446 · Becton, Dickinson & CO
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 88d
Not Cleared May 13, 2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
DEN140004 · Diagnostic Hybrids, Inc.
PGI · Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples · 81d
Cleared May 06, 2014
BD MAX(TM) ENTERIC BACTERIAL PANEL
K140111 · Becton, Dickinson and Company
PCI · Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System · 111d
Cleared May 05, 2014
COBAS CT/NG V2.0 TEST
K140887 · Roche Molecular Systems, Inc.
LSL · Dna-reagents, Neisseria · 28d
Not Cleared Apr 16, 2014
LYRA DIRECT STREP ASSAY
DEN140005 · Quidel Corporation
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 22d
Cleared Mar 26, 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029 · Quidel Corporation
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 79d
Cleared Mar 25, 2014
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
K133673 · Meridian Bioscience, Inc.
OZZ · Bordetella Pertussis Dna Assay System · 116d
Cleared Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605 · Roche Diagnostics
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 270d
Cleared Feb 27, 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 77d
Cleared Feb 14, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
K132909 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 150d
Cleared Jan 31, 2014
WONDFO RAPID STREP A TEST
K133343 · Guangzhou Wondfo Biotech Co., Ltd.
GTY · Antigens, All Groups, Streptococcus Spp. · 93d
Cleared Jan 03, 2014
TRU FLU
K133714 · Meridian Bioscience, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 29d
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 122d
Cleared Dec 20, 2013
AMPLIVUE GBS ASSAY
K133503 · Quidel Corporation
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 36d

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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