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

7048
Total
6986
Cleared
159d
Avg (2y)
1976
Since
1404 Microbiology devices
1026–1050 of 1404
Cleared Mar 12, 1991
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
K904329 · Baxter Healthcare Corp
MCB · Antigen, C. Difficile · 173d
Cleared Mar 12, 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179 · Syva Co.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 113d
Cleared Mar 11, 1991
BACTEC NR-860
K910835 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTA · Monitor, Microbial Growth · 12d
Cleared Mar 04, 1991
OFLOXACIN, 5 MCG SENSI-DISC
K910506 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 27d
Cleared Feb 26, 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · Abbott Laboratories
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 27d
Cleared Jan 18, 1991
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589 · Eastman Kodak Company
GTY · Antigens, All Groups, Streptococcus Spp. · 101d
Cleared Dec 14, 1990
3M IGG FASTLYME(TM) TEST
K895713 · 3M Company
LSR · Reagent, Borrelia Serological Reagent · 445d
Cleared Dec 13, 1990
PATHODX HERPES TYPING
K904167 · Diagnostic Products Corp.
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 93d
Cleared Oct 16, 1990
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
K904036 · Baxter Healthcare Corp
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 41d
Cleared Sep 17, 1990
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926 · Eastman Kodak Company
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 27d
Cleared Sep 12, 1990
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758 · Syva Co.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 23d
Cleared Sep 10, 1990
DIRECTIGEN FLU A
K902609 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GNT · Antigens, Ha (including Ha Control), Influenza Virus A, B, C · 90d
Cleared Aug 22, 1990
REDITEST STREP A TEST KIT
K903194 · Boehringer Mannheim Corp.
GTZ · Antisera, All Groups, Streptococcus Spp. · 34d
Cleared Aug 22, 1990
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 22d
Cleared Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
K902661 · Baxter Healthcare Corp
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 43d
Cleared Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
K902662 · Baxter Healthcare Corp
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 43d
Cleared Jul 27, 1990
IMX CMV IGM ANTIBODY ASSAY
K900473 · Abbott Laboratories
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 176d
Cleared Jul 27, 1990
IMX CMV IGG ANTIBODY ASSAY
K900474 · Abbott Laboratories
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 176d
Cleared Jun 20, 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934 · Eastman Kodak Company
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 51d
Cleared Jun 15, 1990
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
K900546 · Baxter Healthcare Corp
GTH · Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae · 130d
Cleared Jun 01, 1990
PATHODX PYR KIT
K902037 · Diagnostic Products Corp.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 28d
Cleared May 11, 1990
HERPTRAN CONCENTRATE
K900713 · E.I. Dupont DE Nemours & Co., Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 86d
Cleared May 11, 1990
TESTPACK PLUS STREP A
K901274 · Abbott Laboratories
GTZ · Antisera, All Groups, Streptococcus Spp. · 53d
Cleared May 03, 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543 · Abbott Laboratories
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 87d
Cleared Apr 16, 1990
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
K900870 · Diagnostic Products Corp.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 51d

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 1404 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 167 JWY Manual Antimicrobial Susceptibility Test Systems 122 JTN Susceptibility Test Discs, Antimicrobial 71 QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents 31 LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems 30 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 30 JSJ Culture Media, Selective And Non-differential 29 JSM Culture Media, Non-propagating Transport 27 PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays 26 LSR Reagent, Borrelia Serological Reagent 25 PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System 25 QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections 23 MDB System, Blood Culturing 23 LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) 21 JSH Culture Media, Non-selective And Differential 21