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
Jan 27, 2017
chromID Strepto B agar
PQZ
Gbs Culture Media, Selective And Differential
88d
Cleared
Jan 24, 2017
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
88d
Cleared
Jan 12, 2017
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
258d
Cleared
Oct 25, 2016
chromID MRSA
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
90d
Cleared
Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
79d
Cleared
Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
PMT
Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
88d
Cleared
Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
170d
Cleared
Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
263d
Cleared
Mar 25, 2016
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
NGZ
Susceptibility Test Plate, Antifungal
256d
Cleared
Mar 11, 2016
chromID MRSA
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
262d
Cleared
Feb 18, 2016
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
NGZ
Susceptibility Test Plate, Antifungal
227d
Cleared
Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
27d
Cleared
Aug 19, 2014
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
NGZ
Susceptibility Test Plate, Antifungal
239d
Cleared
Aug 05, 2014
VITEK 2 AST - YEAST FLUCONAZOLE
NGZ
Susceptibility Test Plate, Antifungal
232d
Cleared
Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
46d
Cleared
Nov 15, 2013
VITEK 2 AST ST MEROPENEM
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
95d
Cleared
Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
115d
Cleared
Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
28d
Not Cleared
Aug 21, 2013
VITEK MS
PEX
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
231d
Cleared
Jan 25, 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
MDB
System, Blood Culturing
255d
Cleared
Jan 25, 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
MDB
System, Blood Culturing
254d
Cleared
Jan 22, 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
MDB
System, Blood Culturing
250d
Cleared
Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
OCC
Respiratory Virus Panel Nucleic Acid Assay System
263d
Cleared
Nov 20, 2012
VITEK 2 GRAM NEGATIVE DOXYCYCLINE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
179d
Cleared
Nov 19, 2012
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
222d
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