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
751–775 of 1404
Cleared Nov 06, 2012
VRESELECT CULTURE MEDIUM
K122187 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 105d
Cleared Oct 15, 2012
GRAM POSTITVE CLINDAMYCIN
K122547 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 55d
Cleared Oct 12, 2012
ETEST CEFTAROLINE
K121002 · bioMerieux, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 193d
Cleared Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
K122359 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 25d
Cleared Aug 16, 2012
VITEK 2 AST-ST CEFOTAXIME
K121863 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 51d
Cleared Aug 07, 2012
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K113783 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 229d
Cleared Jun 29, 2012
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
K113200 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 242d
Cleared Jun 28, 2012
ARCHITECT HAVAB-G
K113704 · Abbott Laboratories
LOL · Hepatitis A Test (antibody And Igm Antibody) · 195d
Cleared Feb 28, 2012
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
K111893 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 238d
Cleared Feb 17, 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 220d
Cleared Feb 10, 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 93d
Cleared Nov 30, 2011
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
K110106 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 321d
Cleared Oct 26, 2011
VITEK 2 STREPTOCOCCUS PENICILLIN
K112000 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 105d
Cleared Oct 21, 2011
VRESELECT CULTURE MEDIUM
K103684 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 308d
Cleared Oct 18, 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
K111909 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 105d
Cleared Oct 14, 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
K103752 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 295d
Cleared Oct 03, 2011
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
K112228 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 61d
Cleared Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
K112129 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 63d
Cleared Sep 15, 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
K112075 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 57d
Cleared Aug 12, 2011
VITEK 2 AST-ST LINEZOLID
K111599 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 65d
Cleared May 20, 2011
NUCLISENS EASYQ MRSA
K102740 · bioMerieux, Inc.
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 240d
Cleared May 18, 2011
VIDAS TOXO IGG AVIDITY
K101946 · bioMerieux, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 310d
Cleared Jan 13, 2011
PLATELIA ASPERGILLUS EIA MODEL 62793
K093678 · Bio-Rad
NOM · Antigen, Galactomannan, Aspergillus Spp. · 412d
Cleared Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 241d
Cleared Oct 21, 2010
VITEK 2 GRAM POSITIVE DOXCYCLINE
K093076 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 386d

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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 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