FDA Review Panel · MI

FDA 510(k) Microbiology Devices

About Microbiology Devices

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

7038
Total
6976
Cleared
102d
Avg days
1976
Since
363 Microbiology devices
276–300 of 363
Cleared May 16, 2023
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K222736 · Hologic, Inc.
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 249d
Cleared May 05, 2023
Panther Fusion AdV/hMPV/RV Assay
K231017 · Hologic, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 25d
Not Cleared May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
DEN210038 · Ortho-Clinical Diagnostics, Inc.
QVP · Sars-cov-2 Serology Test · 592d
Not Cleared May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
DEN210040 · Ortho-Clinical Diagnostics, Inc.
QVP · Sars-cov-2 Serology Test · 591d
Cleared Apr 26, 2023
Access PCT
K222996 · Beckman Coulter, Inc.
PTF · Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission · 210d
Cleared Apr 17, 2023
Curian® Shiga Toxin
K222829 · Meridian Bioscience, Inc.
GMZ · Antigens, All Types, Escherichia Coli · 210d
Cleared Apr 13, 2023
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
K230719 · Biofire Diagnostics, LLC
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 29d
Cleared Apr 13, 2023
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
K230868 · Maine Molecular Quality Controls, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 15d
Cleared Apr 05, 2023
MicroScan Prompt Inoculation System-D
K221493 · Beckman Coulter, Inc.
LIE · Reagent/device, Inoculum Calibration · 317d
Cleared Mar 24, 2023
BD BACTEC™ Myco/F Lytic Culture Vials
K222559 · Becton, Dickinson and Company
MDB · System, Blood Culturing · 212d
Cleared Mar 24, 2023
BD BACTEC™ Plus Aerobic/F Culture Vials
K222591 · Becton, Dickinson and Company
MDB · System, Blood Culturing · 210d
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 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
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 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 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
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
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

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All categories 363 JWY Manual Antimicrobial Susceptibility Test Systems 32 QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents 29 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 27 PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System 15 JSM Culture Media, Non-propagating Transport 13 JTN Susceptibility Test Discs, Antimicrobial 13 QYT Over-the-counter Covid-19 Antigen Test 13 SCA Multi-analyte Respiratory Virus Antigen Detection Test 11 PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays 10 QQX Respiratory Specimen Nucleic Acid Sars-cov-2 Test 8 QVF Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings 8 QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections 8 NGZ Susceptibility Test Plate, Antifungal 7 SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples 6 PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System 6