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
Not Cleared
Aug 16, 2024
First To Know Syphilis Test
SBZ
Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
233d
Cleared
Aug 12, 2024
iDart Lyme IgG ImmunoBlot Kit
LSR
Reagent, Borrelia Serological Reagent
315d
Cleared
Aug 07, 2024
ADVIA Centaur EBV-VCA IgM
LSE
Epstein-barr Virus, Other
272d
Cleared
Aug 07, 2024
ADVIA Centaur EBV-EBNA IgG
LLM
Test, Antigen, Nuclear, Epstein-barr Virus
272d
Cleared
Aug 02, 2024
Viral Transport Medium
JSM
Culture Media, Non-propagating Transport
273d
Cleared
Jul 30, 2024
Nano-Check™ RSV Test
GQG
Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
180d
Cleared
Jul 24, 2024
Aptima HCV Quant Dx Assay
MZP
Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
299d
Cleared
Jul 18, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
QOF
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
76d
Cleared
Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
JTN
Susceptibility Test Discs, Antimicrobial
91d
Cleared
Jul 15, 2024
Avantik VTM
JSM
Culture Media, Non-propagating Transport
269d
Not Cleared
Jul 15, 2024
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
SBT
Device To Detect Microbial Colonization Directly From Clinical Specimens.
200d
Cleared
Jul 10, 2024
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
QQX
Respiratory Specimen Nucleic Acid Sars-cov-2 Test
264d
Not Cleared
Jun 27, 2024
Xpert HCV
SBP
Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test
72d
Cleared
Jun 26, 2024
Sample Preservative Fluid
QBD
Microbial Nucleic Acid Storage And Stabilization Device
651d
Cleared
Jun 21, 2024
CorDx Tyfast COVID-19 Ag Rapid Test
QYT
Over-the-counter Covid-19 Antigen Test
95d
Cleared
Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
468d
Cleared
Jun 17, 2024
Molecular Transport Media - MTM
QBD
Microbial Nucleic Acid Storage And Stabilization Device
262d
Cleared
Jun 12, 2024
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
NGZ
Susceptibility Test Plate, Antifungal
265d
Cleared
Jun 11, 2024
InActiv Blue
QBD
Microbial Nucleic Acid Storage And Stabilization Device
746d
Cleared
Jun 07, 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
NGZ
Susceptibility Test Plate, Antifungal
260d
Cleared
Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
PEO
Fungal Organisms, Nucleic Acid-based Assay
90d
Cleared
May 31, 2024
iHealth COVID-19 Antigen Rapid Test
QYT
Over-the-counter Covid-19 Antigen Test
179d
Cleared
May 31, 2024
QIAstat-Dx Gastrointestinal Panel 2
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
872d
Cleared
May 30, 2024
SPOTFIRE RSP Pos & Neg Controls
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
23d
Cleared
May 30, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
QOF
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
30d
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