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
1051–1075 of 7095
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 122d
Cleared Dec 20, 2013
BD MAX MRSA XT, BD MAX INSTRUMENT
K133605 · Geneohm Sciences Canada, Inc.
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 25d
Cleared Dec 20, 2013
AMPLIVUE GBS ASSAY
K133503 · Quidel Corporation
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 36d
Cleared Dec 18, 2013
ALERE INFLUENZA A & B TEST
K133637 · Alere Scarborough, Inc D/B/A Binax, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 41d
Cleared Dec 10, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K133474 · Princeton BioMeditech Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 28d
Cleared Dec 05, 2013
ALERE BINAXNOW INFLUENZA A & B CARD
K133411 · Alere Scarborough, Inc D/B/A Binax, Inc.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 28d
Cleared Dec 02, 2013
COBAS CT/NG V2.0 TEST
K132270 · Roche Molecular Systems, Inc.
LSL · Dna-reagents, Neisseria · 133d
Cleared Nov 29, 2013
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
K132726 · Primeradx
OZN · C. Difficile Toxin Gene Amplification Assay · 91d
Cleared Nov 26, 2013
BD MAX STAPHSR ASSAY, INSTRUMENT
K132822 · Geneohm Sciences Canada, Inc. (Bd Diagnostics)
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 78d
Cleared Nov 21, 2013
MALDI BIOTYPER CA (MBT-CA) SYSTEM
K130831 · Bruker Daltonics, Inc.
PEX · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates · 240d
Cleared Nov 15, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · Becton, Dickinson & CO
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 29d
Cleared Nov 15, 2013
VITEK 2 AST ST MEROPENEM
K132507 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 95d
Cleared Nov 13, 2013
BD Veritor™ System Flu A+B Assay
K133138 · Becton, Dickinson & CO
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 27d
Cleared Nov 08, 2013
MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
K131275 · Siemens Helathcare Diagnostics, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 189d
Cleared Nov 07, 2013
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · Becton, Dickinson and Company
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 93d
Cleared Oct 21, 2013
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
K131630 · Puritan Medical Products, LLC
LIO · Device, Specimen Collection · 139d
Cleared Oct 17, 2013
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
K132468 · Elitechgroup Epoch Biosciences
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 71d
Cleared Oct 17, 2013
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
K132251 · Hologic / Gen-Probe Incorporated
LSL · Dna-reagents, Neisseria · 90d
Cleared Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235 · Intelligent Medical Devices, Inc.
OZN · C. Difficile Toxin Gene Amplification Assay · 85d
Cleared Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
K131779 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 115d
Cleared Oct 09, 2013
VIDAS C DIFFICILE GDH
K132010 · Biomerieux S.A.
MCB · Antigen, C. Difficile · 100d
Cleared Oct 02, 2013
BD Veritor™ System Flu A+B Assay
K132693 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 34d
Cleared Sep 23, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 25d
Cleared Sep 23, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K132508 · Centers For Disease Control and Prevention
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 42d
Cleared Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
K132573 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 28d

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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