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

7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5928 Microbiology devices
976–1000 of 5928
Cleared Oct 09, 2014
LYRA PARAINFLUENZA VIRUS ASSAY
K141927 · Quidel Corporation
OOU · Parainfluenza Multiplex Nucleic Acid Assay · 85d
Not Cleared Sep 22, 2014
T2CANDIDA AND T2DX INSTRUMENT
DEN140019 · T2biosystems, Inc.
PII · Candida Species Nucleic Acid Detection System · 118d
Cleared Sep 16, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
K140377 · Luminex Molecular Diagnostics, Inc.
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 214d
Cleared Sep 03, 2014
ALERE PBP2A SA/CONS CULTURE COLONY TEST
K133851 · Alere Scarborough, Inc.
MYI · System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies · 258d
Cleared Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
K141772 · Siemens Healthcare Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 49d
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
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
K141859 · Centers For Disease Control and Prevention
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 22d
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 Jul 01, 2014
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
K141458 · Focus Diagnostics
PGH · Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel · 29d
Cleared Jun 30, 2014
MUELLER HINTON AGAR
K132491 · Edge Biologicals, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 326d
Cleared Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
K141149 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 46d
Cleared Jun 20, 2014
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
K140083 · Nanosphere, Inc.
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 158d
Cleared Jun 13, 2014
ALERE I INFLUENZA A & B
K141520 · Alere Scarborough, Inc D/B/A Binax, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 4d
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 22, 2014
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
K141220 · Thermo Fisher Scientific (Life Technologies Holdin
NSU · Instrumentation For Clinical Multiplex Test Systems · 10d
Cleared May 22, 2014
CAPTIA MEASLES IGM
K140455 · Trinity Biotech USA
PCL · Enzyme Linked Immunoabsorbent Assay, Rubeola Igm · 87d
Cleared May 22, 2014
ANTHRACIS REAL-TIME PCR ASSAY
K140426 · Centers For Disease Control and Prevention (Cdc)
NHT · Assay, Nucleic Acid Amplification, Bacillus Anthracis · 92d
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

Looking for a specific microbiology device? Search by device name, K-number or manufacturer.

Search all Microbiology 510(k) devices

Filter by Product Code

All categories 5928 JWY Manual Antimicrobial Susceptibility Test Systems 407 JTN Susceptibility Test Discs, Antimicrobial 316 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 284 JSJ Culture Media, Selective And Non-differential 264 JSI Culture Media, Selective And Differential 216 JTO Discs, Strips And Reagents, Microorganism Differentiation 194 JSG Culture Media, Non-selective And Non-differential 181 JSH Culture Media, Non-selective And Differential 115 LSR Reagent, Borrelia Serological Reagent 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 94 GTZ Antisera, All Groups, Streptococcus Spp. 84 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 79 JSM Culture Media, Non-propagating Transport 77 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 74