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
5931 Microbiology devices
2351–2375 of 5931
Cleared Aug 12, 1997
ACCURUN 121 HAV IGM POSITIVE CONTROL
K971657 · Boston Biomedica, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 98d
Cleared Aug 12, 1997
ACCURUN 117 HBEAG POSITIVE CONTROL
K972048 · Boston Biomedica, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 71d
Cleared Aug 12, 1997
CHLAMYDIATROL AG
K972129 · Blackhawk Biosystems, Inc.
MJZ · Kit, Direct Antigen, Positive Control · 67d
Cleared Aug 08, 1997
ROTAVIRUS EIA
K964424 · Trinity Biotech, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 276d
Cleared Aug 08, 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758 · Becton Dickinson Microbiology Systems
MDB · System, Blood Culturing · 53d
Cleared Aug 07, 1997
ACCURUN 120 HAV IGG POSITIVE CONTROL
K971406 · Boston Biomedica, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 113d
Cleared Aug 07, 1997
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
K972307 · Boston Biomedica, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 49d
Cleared Aug 01, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K972180 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 52d
Cleared Aug 01, 1997
MODIFICATION OF EST CULTURE SYSTEM II - MYCO
K972756 · Accumed Intl., Inc.
MDB · System, Blood Culturing · 63d
Cleared Jul 28, 1997
FOSFOMYCIN, 200 MG, SENSI-DISC
K972098 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 54d
Cleared Jul 23, 1997
STREP A OIA MAX
K962060 · Biostar, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 421d
Cleared Jul 22, 1997
TOX A/B TEST
K971182 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 113d
Cleared Jul 22, 1997
QUANTA LITE RUBEOLA (MEASLES) IGG
K971620 · Inova Diagnostics, Inc.
LJB · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg · 82d
Cleared Jul 14, 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · Immunoprobe, Inc.
LJZ · Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. · 96d
Cleared Jul 14, 1997
ETEST FOR LEVOFLOXACIN
K971697 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 67d
Cleared Jul 08, 1997
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · Consolidated Technologies, Inc.
LYR · Helicobacter Pylori · 29d
Cleared Jul 07, 1997
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
K971349 · Princeton BioMeditech Corp.
GTY · Antigens, All Groups, Streptococcus Spp. · 88d
Cleared Jul 03, 1997
CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971631 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 62d
Cleared Jul 03, 1997
PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971633 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 62d
Cleared Jul 03, 1997
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971635 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 62d
Cleared Jul 01, 1997
HSV-1 ANTIGEN CONTROL SLIDES
K964874 · Viral Antigens, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 208d
Cleared Jul 01, 1997
HSV-2 ANTIGEN CONTROL SLIDES
K971101 · Viral Antigens, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 97d
Cleared Jun 30, 1997
ETEST FOR CEFTAZIDIME
K971694 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 54d
Cleared Jun 27, 1997
PYLORISET EIA-G (68926)
K971537 · Orion Diagnostica, Div. Orion Corp.
LYR · Helicobacter Pylori · 60d
Cleared Jun 19, 1997
INDICARD TEST
K964015 · Litmus Concepts, Inc.
MJM · Dna Probe, Gardnerella Vaginalis · 255d

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All categories 5931 JWY Manual Antimicrobial Susceptibility Test Systems 408 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 75