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
7061
Total
6999
Cleared
155d
Avg (2y)
1976
Since
4573 Microbiology devices
Cleared
Feb 11, 2019
BacT/ALERT FA Plus
MDB
System, Blood Culturing
88d
Cleared
Feb 04, 2019
Capture-CMV
LJO
Antigen, Iha, Cytomegalovirus
45d
Not Cleared
Jan 23, 2019
Aptima Mycoplasma genitalium Assay
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
145d
Cleared
Jan 18, 2019
HardyDisk AST Omadacycline 30µg (OMC30)
JTN
Susceptibility Test Discs, Antimicrobial
52d
Cleared
Jan 11, 2019
MTS Tetracycline 0.016 - 256 ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
59d
Cleared
Jan 11, 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
71d
Cleared
Jan 08, 2019
BD MAX CTGCTV2, BD MAX System
OUY
Trichomonas Vaginalis Nucleic Acid Amplification Test System
103d
Cleared
Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
JWY
Manual Antimicrobial Susceptibility Test Systems
64d
Cleared
Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
PEO
Fungal Organisms, Nucleic Acid-based Assay
85d
Cleared
Dec 21, 2018
VITEK MS
QBN
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
205d
Cleared
Dec 20, 2018
MTS Levofloxacin 0.002 - 32 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
41d
Cleared
Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
PAM
Gram-positive Bacteria And Their Resistance Markers
178d
Cleared
Dec 19, 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
OZZ
Bordetella Pertussis Dna Assay System
29d
Cleared
Dec 17, 2018
Acucy Influenza A&B Test with the Acucy System
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
144d
Cleared
Dec 14, 2018
MTS Omadacycline 0.002-32 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
56d
Cleared
Dec 10, 2018
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
160d
Cleared
Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
29d
Cleared
Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
29d
Cleared
Nov 30, 2018
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
60d
Cleared
Nov 30, 2018
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
GMQ
Antigens, Nontreponemal, All
87d
Not Cleared
Nov 30, 2018
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
QDZ
Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
123d
Cleared
Nov 29, 2018
BD MAX Enteric Viral Panel, BD MAX Instrument
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
181d
Cleared
Nov 23, 2018
Accula RSV Test
OCC
Respiratory Virus Panel Nucleic Acid Assay System
176d
Cleared
Nov 15, 2018
FilmArray Pneumonia Panel plus
QDS
Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System
181d
Cleared
Nov 09, 2018
FilmArray Pneumonia Panel
QDP
Respiratory Panel
210d
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