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
7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5926 Microbiology devices
Cleared
Jul 05, 2018
FilmArray Blood Culture Identification (BCID) Panel
PEN
Gram-negative Bacteria And Associated Resistance Markers
29d
Cleared
Jul 03, 2018
ETEST Telavancin (TLA) (0.002-32 ug/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
84d
Cleared
Jun 26, 2018
NeuMoDx GBS Assay
NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
203d
Cleared
Jun 22, 2018
OSOM Mono Test
KTN
System, Test, Infectious Mononucleosis
21d
Cleared
Jun 20, 2018
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
NGZ
Susceptibility Test Plate, Antifungal
28d
Cleared
Jun 14, 2018
ASI Evolution
GMQ
Antigens, Nontreponemal, All
227d
Cleared
Jun 13, 2018
Aptima Combo 2 Assay (Panther System)
LSL
Dna-reagents, Neisseria
90d
Cleared
Jun 01, 2018
PanNAT STEC Test
PCI
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
221d
Cleared
May 24, 2018
T2Bacteria Panel
QBX
Direct Blood Bacterial Nucleic Acid Detection System
258d
Cleared
May 18, 2018
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
44d
Cleared
May 02, 2018
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
LSR
Reagent, Borrelia Serological Reagent
92d
Cleared
May 02, 2018
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
PGX
Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
155d
Cleared
May 01, 2018
BacterioScan 216Dx System
QBQ
System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
264d
Cleared
Apr 26, 2018
Xpert Xpress Strep A
PGX
Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
177d
Not Cleared
Apr 20, 2018
MALDI Biotyper CA System
QBN
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
203d
Cleared
Apr 04, 2018
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
56d
Not Cleared
Apr 03, 2018
Curetis Unyvero LRT Application
QBH
Lower Respiratory Microbial Nucleic Acid Detection System
204d
Cleared
Mar 23, 2018
UriSwab-Urine Collection, Transport and Preservation System
JSM
Culture Media, Non-propagating Transport
74d
Cleared
Mar 22, 2018
Granada Medium
PQZ
Gbs Culture Media, Selective And Differential
90d
Cleared
Mar 21, 2018
cobas CT/NG for use on cobas 6800/8800 systems
LSL
Dna-reagents, Neisseria
90d
Cleared
Mar 20, 2018
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
28d
Not Cleared
Mar 19, 2018
PrimeStore MTM
QBD
Microbial Nucleic Acid Storage And Stabilization Device
299d
Cleared
Mar 16, 2018
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
MDB
System, Blood Culturing
86d
Cleared
Mar 16, 2018
Xpert CT/NG
LSL
Dna-reagents, Neisseria
88d
Cleared
Mar 15, 2018
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
37d
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