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

326–350 of 1404

Cleared Mar 21, 2023

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)

K223844 · Thermo Fisher Scientific

JWY · Manual Antimicrobial Susceptibility Test Systems · 89d

Cleared Mar 20, 2023

K223245 · Copan Wasp Srl

QQV · Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry · 151d

Cleared Mar 17, 2023

Simplexa COVID-19 & Flu A/B Direct

K220963 · Diasorin Molecular, LLC

QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 350d

Cleared Mar 16, 2023

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

K230404 · Biofire Diagnostics, LLC

PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 29d

Cleared Mar 10, 2023

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

K221198 · Thermo Fisher Scientific

NGZ · Susceptibility Test Plate, Antifungal · 318d

Cleared Mar 10, 2023

Lyra RSV+hMPV Assay

K230349 · Quidel Corporation

OEM · Human Metapneumovirus (hmpv) Rna Assay System · 29d

Cleared Mar 09, 2023

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

K222430 · Biomerieux Sa, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 210d

Not Cleared Mar 08, 2023

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

DEN220039 · Quidel Corporation

QVF · Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings · 265d

Cleared Mar 07, 2023

Visby Medical Sexual Health Test

K220407 · Visby Medical

QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 386d

Cleared Mar 06, 2023

BD Vaginal Panel

K223653 · Becton, Dickinson and Company

PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System · 90d

Cleared Mar 03, 2023

Alinity m STI Assay

K222379 · Abbott Molecular, Inc.

QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 210d

Cleared Mar 03, 2023

Lyra Influenza A+B Assay

K230236 · Quidel Corporation

OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 32d

Cleared Feb 17, 2023

Spectrum Saliva Collection Device

K223497 · Spectrum Solutions, LLC

QBD · Microbial Nucleic Acid Storage And Stabilization Device · 88d

Cleared Feb 16, 2023

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)

K223478 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 90d

Cleared Feb 09, 2023

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

K222073 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 210d

Cleared Feb 03, 2023

BIOFIRE SPOTFIRE Respiratory (R) Panel

K213954 · Biofire Diagnostics

QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 413d

Cleared Feb 03, 2023

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

K221253 · Maine Molecular Quality Controls, Inc.

PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 277d

Cleared Feb 03, 2023

VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)

K223481 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 77d

Not Cleared Feb 03, 2023

Active Anthrax DetectTM Plus Rapid Test

DEN220044 · InBios International, Inc.

QUU · Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples · 210d

Cleared Jan 27, 2023

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin

K220803 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 315d

Cleared Jan 27, 2023

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 120d

Cleared Jan 26, 2023

K222779 · Meridian Bioscience, Inc.

OOI · Real Time Nucleic Acid Amplification System · 134d

Cleared Jan 20, 2023

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml

K221899 · Thermo Fisher Scientific

NGZ · Susceptibility Test Plate, Antifungal · 204d

Cleared Jan 19, 2023

Biosci™ Inactivated Transport Medium, Biosci™ ITM

K220059 · Shenzhen Dakewe Bio-Engineering Co., Ltd.

QBD · Microbial Nucleic Acid Storage And Stabilization Device · 374d

Cleared Jan 18, 2023

Selux AST System

K211759 · Selux Diagnostics, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 590d

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