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
Cleared
Jul 24, 2018
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
OCC
Respiratory Virus Panel Nucleic Acid Assay System
180d
Cleared
Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
PMT
Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
91d
Cleared
Jul 15, 2018
Solana Bordetella Complete Assay
OZZ
Bordetella Pertussis Dna Assay System
88d
Cleared
Jul 10, 2018
HardyDisk AST Plazomicin 30ug (PLZ30)
JTN
Susceptibility Test Discs, Antimicrobial
13d
Cleared
Jul 06, 2018
Elecsys BRAHMS PCT
PRI
Procalcitonin Assay
192d
Cleared
Jul 06, 2018
CHROMID CARBA agar (CARB)
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
72d
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
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 02, 2018
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
LSR
Reagent, Borrelia Serological Reagent
92d
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
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