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

7061
Total
6999
Cleared
155d
Avg (2y)
1976
Since
4573 Microbiology devices
526–550 of 4573
Cleared Nov 04, 2019
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
K191160 · Luminex Molecular Diagnostics, Inc.
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 187d
Cleared Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Oct 31, 2019
Vitek Densichek
K192110 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 87d
Cleared Oct 28, 2019
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
K192046 · DiaSorin, Inc.
QFO · Zika Virus Serological Reagents · 89d
Cleared Oct 21, 2019
BD MAX Vaginal Panel
K191957 · Geneohm Sciences Canada, Inc. (Bd Diagnostics)
PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System · 90d
Cleared Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
K192250 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 58d
Not Cleared Oct 10, 2019
OraQuick Ebola Rapid Antigen Test
DEN190025 · OraSure Technologies, Inc.
QID · Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens · 150d
Cleared Oct 07, 2019
Cepheid Xpert Respiratory Control Panel
K190086 · Microbiologics, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 263d
Cleared Oct 02, 2019
NG-Test CARBA 5
K191889 · Ng Biotech
PTJ · Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates · 79d
Cleared Oct 01, 2019
Applied Biosystems Bacillus anthracis Detection Kit
K183462 · Mriglobal
QIF · 291d
Cleared Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
K192050 · Biomerieux S.A.
JWY · Manual Antimicrobial Susceptibility Test Systems · 58d
Cleared Sep 25, 2019
ARIES MRSA Assay
K191742 · Luminex Corporation
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 86d
Cleared Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 23d
Cleared Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
K191908 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 50d
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613 · Check-Points Health B.V.
POC · System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen · 171d
Cleared Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 49d
Cleared Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953 · Biomerieux S.A.
JWY · Manual Antimicrobial Susceptibility Test Systems · 31d
Cleared Aug 13, 2019
Elecsys Anti-HAV II
K190428 · Roche Diagnostics
LOL · Hepatitis A Test (antibody And Igm Antibody) · 172d
Cleared Aug 08, 2019
binx health io CT/NG Assay
K191352 · Binx Health, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 80d
Cleared Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
K191766 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 35d
Cleared Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
K191931 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 12d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191398 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 66d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191240 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 82d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K190907 · Zeus Scientific, Inc.
LSR · Reagent, Borrelia Serological Reagent · 112d
Cleared Jul 24, 2019
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
K191729 · Roche Molecular Systems, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 27d

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All categories 4573 JWY Manual Antimicrobial Susceptibility Test Systems 361 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 282 JTN Susceptibility Test Discs, Antimicrobial 276 JSJ Culture Media, Selective And Non-differential 232 JSI Culture Media, Selective And Differential 175 JSG Culture Media, Non-selective And Non-differential 168 JTO Discs, Strips And Reagents, Microorganism Differentiation 144 JSH Culture Media, Non-selective And Differential 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 75 GRM Antisera, All Groups, Salmonella Spp. 66 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 62 GTZ Antisera, All Groups, Streptococcus Spp. 59 JSF Culture Media, Single Biochemical Test 58 MDB System, Blood Culturing 54 GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. 51