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

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
901–925 of 7095
Cleared May 10, 2016
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
K152679 · Bio-Rad Laboratories
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 235d
Cleared Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
K152075 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 263d
Cleared Apr 12, 2016
ARIES System
K160517 · Luminex Corporation
OOI · Real Time Nucleic Acid Amplification System · 48d
Cleared Apr 01, 2016
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
K160459 · Biofire Diagnostics, LLC
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 42d
Cleared Mar 31, 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
K153687 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 99d
Not Cleared Mar 28, 2016
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
DEN150058 · Bio-Rad Laboratories
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 103d
Cleared Mar 25, 2016
Great Basin Staph ID/R Blood Culture Panel
K152470 · Great Basin Scientific, Inc.
PAM · Gram-positive Bacteria And Their Resistance Markers · 207d
Cleared Mar 25, 2016
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
K151923 · bioMerieux, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 256d
Cleared Mar 22, 2016
Great Basin Shiga Toxin Direct Test
K152955 · Great Basin Scientific, Inc.
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 167d
Cleared Mar 17, 2016
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
K160462 · Biofire Diagnostics, LLC
PLO · Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System · 27d
Cleared Mar 15, 2016
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
K160457 · Biofire Diagnostics, LLC
PEN · Gram-negative Bacteria And Associated Resistance Markers · 25d
Cleared Mar 14, 2016
ImmunoCard STAT! HpSA
K153661 · Meridian Bioscience, Inc.
LYR · Helicobacter Pylori · 84d
Cleared Mar 11, 2016
chromID MRSA
K151688 · bioMerieux, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 262d
Cleared Mar 07, 2016
Xpert Carba-R
K152614 · Cepheid
PMY · System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony · 175d
Cleared Feb 25, 2016
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
K160164 · Becton, Dickinson & CO
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 29d
Cleared Feb 25, 2016
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866 · Becton, Dickinson and Company
MDB · System, Blood Culturing · 231d
Cleared Feb 24, 2016
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K160161 · Becton, Dickinson & CO
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 28d
Not Cleared Feb 20, 2016
B.R.A.H.M.S PCT sensitive KRYPTOR
DEN150009 · Brahms GmbH
PMT · Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens · 353d
Cleared Feb 18, 2016
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
K151817 · bioMerieux, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 227d
Cleared Feb 08, 2016
FilmArray Respiratory Panel (RP) for use with FilmArray Torch
K160068 · Biofire Diagnostics, LLC
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 26d
Cleared Jan 15, 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
K151320 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 242d
Cleared Jan 12, 2016
Sofia Influenza A+B FIA
K153012 · Quidel Corporation
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 90d
Cleared Dec 22, 2015
ADVIA Centaur Toxoplasma M (Toxo M)
K142826 · Siemens Healthcare Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 448d
Cleared Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
K152774 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 87d
Cleared Dec 17, 2015
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
K152386 · Luminex Molecular Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 115d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87