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
1101–1125 of 5928
Cleared Jan 16, 2013
PRO HMPV+ ASSAY
K123838 · Gen-Probe Prodesse, Inc.
OEM · Human Metapneumovirus (hmpv) Rna Assay System · 34d
Cleared Jan 16, 2013
PROGASTRO SSCS ASSAY
K123274 · Gen-Probe Prodesse, Inc.
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 89d
Cleared Jan 14, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K123905 · Centers For Disease Control and Prevention
OQW · 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification · 26d
Not Cleared Jan 14, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
DEN130003 · Luminex Molecular Diagnostics, Inc.
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 3d
Cleared Jan 09, 2013
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
K122062 · Gen-Probe, Inc.
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 180d
Cleared Jan 07, 2013
ENTEROCOCCUS QUICKFISH BC
K121991 · Advandx, Inc.
OAH · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis · 185d
Cleared Dec 27, 2012
XPERT CT/NG
K121710 · Cepheid
LSL · Dna-reagents, Neisseria · 199d
Cleared Dec 21, 2012
XPERT FLU
K123191 · Cepheid
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 71d
Cleared Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
K121003 · Abbott Laboratories
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 263d
Cleared Dec 17, 2012
ALPHA CRYPTOCOCCAL ANTIGEN EIA
K120946 · Immuno-Mycologics, Inc.
MDU · Antigen, Elisa, Cryptococcus · 263d
Cleared Dec 13, 2012
AMPLIVUE C. DIFFICILE ASSAY
K123355 · Quidel Corporation
OZN · C. Difficile Toxin Gene Amplification Assay · 43d
Cleared Dec 05, 2012
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
K123197 · Nanosphere, Inc.
OZN · C. Difficile Toxin Gene Amplification Assay · 55d
Cleared Nov 20, 2012
VITEK 2 GRAM NEGATIVE DOXYCYCLINE
K121546 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 179d
Cleared Nov 19, 2012
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
K121100 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 222d
Cleared Nov 06, 2012
VRESELECT CULTURE MEDIUM
K122187 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 105d
Cleared Nov 05, 2012
OSOM INFLUENZA A&B TEST MODEL 190
K123182 · SEKISUI Diagnostics, LLC
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 26d
Cleared Nov 02, 2012
BIOPLEX 2200 EBV IGM KIT
K123021 · Bio-Rad Laboratories
LJN · Antibody Igm, If, Epstein-barr Virus · 36d
Cleared Nov 02, 2012
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
K121539 · Cepheid
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 162d
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 Oct 02, 2012
SHIGA TOXIN CHEK
K121411 · Techlab Inc., Corporate Research Center
GMZ · Antigens, All Types, Escherichia Coli · 144d
Cleared Oct 02, 2012
SHIGA TOXIN QUIK CHEK
K121364 · Techlab Inc., Corporate Research Center
GMZ · Antigens, All Types, Escherichia Coli · 148d
Cleared Sep 19, 2012
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
K122514 · Nanosphere, Inc.
PAM · Gram-positive Bacteria And Their Resistance Markers · 33d
Cleared Sep 18, 2012
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633 · Becton, Dickinson and Company
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 106d
Cleared Sep 13, 2012
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
K122019 · Meridian Bioscience, Inc.
OYZ · Group A Streptococcus Nucleic Acid Amplification Assay System · 65d

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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