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
776–800 of 1404
Cleared Sep 28, 2010
VITEK 2 YEAST CASPOFUNGIN
K101566 · bioMerieux, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 116d
Cleared Jul 06, 2010
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
K093383 · bioMerieux, Inc.
OOI · Real Time Nucleic Acid Amplification System · 249d
Cleared May 21, 2010
VITEK 2 YEAST VORICONAZOLE
K092454 · bioMerieux, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 284d
Cleared Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
K091025 · bioMerieux, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 326d
Cleared Nov 10, 2009
ELECSYS TOXO IGG CALCHECK 5
K092888 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 50d
Cleared Nov 09, 2009
DENSICHECK PLUS
K093224 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 26d
Cleared Sep 11, 2009
DENSICHEK PLUS
K083536 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 287d
Cleared Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 50d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · bioMerieux, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 98d
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 59d
Cleared Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 213d
Cleared Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K083383 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 93d
Cleared Dec 23, 2008
VIDAS RUB IGG
K080766 · bioMerieux, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 280d
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · Roche Diagnostics Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 445d
Cleared Jun 26, 2008
PLATELIA LYME IGM
K081362 · Bio-Rad
LSR · Reagent, Borrelia Serological Reagent · 42d
Cleared Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
K063261 · bioMerieux, Inc.
OAI · Assay, Enterovirus Nucleic Acid · 602d
Cleared Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
K081212 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 45d
Cleared Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · bioMerieux, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 70d
Cleared Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · Roche Diagnostics Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 179d
Cleared May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
K080869 · Beckman Coulter, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 53d
Cleared May 08, 2008
PLATELIA LYME IGG ASSAY
K080012 · Bio-Rad
LSR · Reagent, Borrelia Serological Reagent · 126d
Cleared Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
K080201 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 93d
Cleared Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
K080107 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 44d
Cleared Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K073406 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 50d
Cleared Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · bioMerieux, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 141d

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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 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 30 LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems 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 JSH Culture Media, Non-selective And Differential 21 LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) 21