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
Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
58d
Not Cleared
Oct 10, 2019
OraQuick Ebola Rapid Antigen Test
QID
Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
150d
Cleared
Oct 07, 2019
Cepheid Xpert Respiratory Control Panel
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
263d
Cleared
Oct 02, 2019
NG-Test CARBA 5
PTJ
Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates
79d
Cleared
Oct 01, 2019
Applied Biosystems Bacillus anthracis Detection Kit
QIF
291d
Cleared
Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
58d
Cleared
Sep 25, 2019
ARIES MRSA Assay
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
86d
Cleared
Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
JTN
Susceptibility Test Discs, Antimicrobial
23d
Cleared
Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
50d
Cleared
Aug 29, 2019
BD MAX Check-Points CPO
POC
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
171d
Cleared
Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
49d
Cleared
Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
31d
Cleared
Aug 13, 2019
Elecsys Anti-HAV II
LOL
Hepatitis A Test (antibody And Igm Antibody)
172d
Cleared
Aug 08, 2019
binx health io CT/NG Assay
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
80d
Cleared
Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
35d
Cleared
Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
JTN
Susceptibility Test Discs, Antimicrobial
12d
Cleared
Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
LSR
Reagent, Borrelia Serological Reagent
112d
Cleared
Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
LSR
Reagent, Borrelia Serological Reagent
82d
Cleared
Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
LSR
Reagent, Borrelia Serological Reagent
66d
Cleared
Jul 24, 2019
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
OCC
Respiratory Virus Panel Nucleic Acid Assay System
27d
Cleared
Jul 17, 2019
Fungitell STAT
NQZ
Antigen, Invasive Fungal Pathogens
77d
Cleared
Jul 17, 2019
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
QFO
Zika Virus Serological Reagents
33d
Cleared
Jul 11, 2019
ID NOW Influenza A & B 2
OCC
Respiratory Virus Panel Nucleic Acid Assay System
31d
Cleared
Jul 01, 2019
BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
84d
Cleared
Jun 28, 2019
iC-GN iC-Cassette for use on the iC-System
PEN
Gram-negative Bacteria And Associated Resistance Markers
134d
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