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

7048
Total
6986
Cleared
159d
Avg (2y)
1976
Since
1404 Microbiology devices
476–500 of 1404
Cleared Jun 03, 2020
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
K200506 · Chembio Diagnostic Systems
QFO · Zika Virus Serological Reagents · 93d
Cleared May 17, 2020
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
K200866 · Hologic, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 46d
Not Cleared May 11, 2020
NP Screen
DEN190031 · Advance Sentry Corporation
OJY · Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers · 322d
Cleared May 07, 2020
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
K200512 · Biom?rieux SA
JWY · Manual Antimicrobial Susceptibility Test Systems · 66d
Cleared Apr 28, 2020
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
K200590 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 53d
Cleared Apr 27, 2020
binx io CT/NG Assay and binx io CT/NG System
K200533 · Binx Health, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 56d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K200023 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 91d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K200025 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 91d
Cleared Apr 06, 2020
MTS Lefamulin 0.016- 256 µg/mL
K200308 · Liofilchem S. R. 1.
JWY · Manual Antimicrobial Susceptibility Test Systems · 60d
Cleared Apr 03, 2020
Osom Ultra Plus Flu A&B Test Kit
K192719 · SEKISUI Diagnostics, LLC
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 190d
Cleared Apr 02, 2020
FilmArray BCID2 Control Panel M416
K200010 · Maine Molecular Quality Controls, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 91d
Cleared Mar 23, 2020
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
K200436 · Hologic, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 28d
Cleared Mar 20, 2020
MTS Omadacycline 0.002 - 32 ug/mL
K200180 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 56d
Cleared Mar 18, 2020
BioFire Blood Culture Identification 2 (BCID2) Panel
K193519 · Biofire Diagnostics, LLC
PEN · Gram-negative Bacteria And Associated Resistance Markers · 90d
Cleared Mar 18, 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
K193536 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 89d
Cleared Mar 13, 2020
Curian HpSA, Curian Analyzer
K192817 · Meridian Bioscience, Inc.
LYR · Helicobacter Pylori · 164d
Cleared Mar 13, 2020
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
K193572 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 81d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml
K193538 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 83d
Cleared Mar 10, 2020
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
K200370 · Centers For Disease Control and Prevention
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 25d
Cleared Mar 09, 2020
Elecsys BRAHMS PCT
K192815 · Roche Diagnostics
PRI · Procalcitonin Assay · 160d
Cleared Mar 05, 2020
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K191184 · Ssi Diagnostica A/S
MJH · Legionella, Spp., Elisa · 307d
Cleared Mar 03, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
K193358 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 90d
Cleared Mar 02, 2020
LIAISON Anti-HAV Assay
K193532 · DiaSorin, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 73d
Cleared Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
K200236 · Ortho-Clinical Diagnostics
PMT · Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens · 26d
Cleared Feb 18, 2020
CareStart Flu A&B Plus
K191514 · Access Bio, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 256d

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All categories 1404 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 167 JWY Manual Antimicrobial Susceptibility Test Systems 122 JTN Susceptibility Test Discs, Antimicrobial 71 QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents 31 LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems 30 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 30 JSJ Culture Media, Selective And Non-differential 29 JSM Culture Media, Non-propagating Transport 27 PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays 26 LSR Reagent, Borrelia Serological Reagent 25 PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System 25 MDB System, Blood Culturing 23 QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections 23 LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) 21 JSH Culture Media, Non-selective And Differential 21