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
1126–1150 of 5928
Cleared Sep 10, 2012
ESENSOR RESPIRATORY VIRAL PANEL
K113731 · Clinical Micro Sensors, Inc.
JJH · Clinical Sample Concentrator · 266d
Cleared Sep 07, 2012
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K121797 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 80d
Cleared Sep 06, 2012
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
K122397 · DiaSorin, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 30d
Cleared Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
K122359 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 25d
Cleared Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
K121895 · Roche Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 56d
Cleared Aug 16, 2012
STRATIFY JCV DXSELECT
K120986 · Focus Diagnostics, Inc.
OYP · Anti-jcv Antibody Detection Assay · 136d
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 Aug 07, 2012
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994 · Becton, Dickinson and Company
MDB · System, Blood Culturing · 127d
Cleared Jul 26, 2012
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
K113397 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 252d
Cleared Jul 26, 2012
ALERE PBP2A TEST
K121905 · Alere Scarborough, Inc.
MYI · System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies · 27d
Cleared Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K120625 · Roche Diagnostics
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 146d
Cleared Jul 13, 2012
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
K120413 · Focus Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 154d
Cleared Jul 05, 2012
BD MAX MRSA ASSAY, BD MAX INSTRUMENT
K120138 · Bd Diagnostics (Geneohm Sciences Canada, Inc)
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 170d
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
Not Cleared Jun 26, 2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
DEN120014 · Nanosphere, Inc.
PAM · Gram-positive Bacteria And Their Resistance Markers · 11d
Cleared Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
K120959 · Bio-Rad Laboratories
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 84d
Cleared Jun 08, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K120846 · Puritan Medical Products, LLC
LIO · Device, Specimen Collection · 80d
Cleared Jun 01, 2012
MRSA/SA ELITE MGB
K112937 · Elitech
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 242d
Cleared Jun 01, 2012
BORRELIA BURGDORFERI IGM BLOT TEST
K113846 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 155d
Cleared May 25, 2012
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K121039 · Copan Flock Technologies
JTW · System, Transport, Aerobic · 50d
Not Cleared May 24, 2012
CDC DENV-1-4 REAL TIME RT-PCT ASSAY
DEN120012 · Centers For Disease Control and Prevention
OZB · Dengue Nucleic Acid Amplification Assay (naat) · 73d
Cleared May 18, 2012
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
K120911 · Cepheid
OQW · 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification · 53d
Cleared May 15, 2012
FILMARRAY RP PANEL
K120267 · Idaho Technology, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 106d

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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