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
701–725 of 1404
Cleared Dec 07, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)
K172912 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 73d
Cleared Dec 04, 2017
Panther Fusion AdV/hMPV/RV Assay
K172629 · Hologic, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 94d
Cleared Dec 01, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
K172255 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 128d
Cleared Oct 23, 2017
Panther Fusion Paraflu Assay
K172282 · Hologic, Inc.
OOU · Parainfluenza Multiplex Nucleic Acid Assay · 87d
Cleared Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
K172621 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 33d
Cleared Sep 26, 2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
K171963 · Hologic, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 88d
Cleared Sep 15, 2017
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
K172150 · bioMerieux, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 60d
Cleared Aug 01, 2017
HardyDisk AST Delafloxacin 5 µg (DLX5)
K171975 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 32d
Cleared Jul 22, 2017
VITEK MS
K162950 · bioMerieux, Inc.
PEX · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates · 271d
Cleared Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · Roche Diagnostics
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 270d
Cleared Jun 21, 2017
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
K162737 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 264d
Cleared Jun 15, 2017
Aptima Herpes Simplex Viruses 1 & 2 Assay
K162673 · Hologic, Inc.
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 262d
Cleared May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
K170670 · bioMerieux, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 86d
Cleared May 22, 2017
Strep B Carrot Broth One-Step
K170586 · Hardy Diagnostics
PQZ · Gbs Culture Media, Selective And Differential · 83d
Cleared May 16, 2017
Strep B Carrot Broth Kit
K170481 · Hardy Diagnostics
PQZ · Gbs Culture Media, Selective And Differential · 89d
Cleared May 02, 2017
BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · Becton, Dickinson and Company
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 90d
Cleared Mar 28, 2017
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816 · bioMerieux, Inc.
MDB · System, Blood Culturing · 270d
Cleared Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
K162740 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 172d
Cleared Mar 17, 2017
Elecsys CMV IgM
K163569 · Roche Diagnostics
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 88d
Cleared Mar 14, 2017
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
K170127 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 60d
Cleared Mar 13, 2017
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)
K163563 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 84d
Cleared Feb 23, 2017
VIDAS B.R.A.H.M.S. PCT (PCT)
K162827 · bioMerieux, Inc.
PRI · Procalcitonin Assay · 139d
Cleared Feb 16, 2017
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
K161437 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 268d
Cleared Feb 13, 2017
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
K161510 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 257d
Cleared Feb 01, 2017
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)
K163083 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 90d

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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 QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections 23 MDB System, Blood Culturing 23 JSH Culture Media, Non-selective And Differential 21 LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) 21