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
4572 Microbiology devices
Cleared
Jul 05, 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
98d
Cleared
Jul 03, 2023
Premier HpSA Flex (619096)
LYR
Helicobacter Pylori
94d
Cleared
Jul 03, 2023
CLEARinse CTS Specimen Collection and Transport System
QBD
Microbial Nucleic Acid Storage And Stabilization Device
390d
Cleared
Jun 30, 2023
MeMed BV
QPS
Immunoassay For Host Biomarkers Of Infection
87d
Cleared
Jun 30, 2023
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
JWY
Manual Antimicrobial Susceptibility Test Systems
88d
Cleared
Jun 30, 2023
FebriDx Bacterial / Non-bacterial Point of Care Assay
QXA
Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
88d
Cleared
Jun 26, 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
325d
Cleared
Jun 07, 2023
BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
JTN
Susceptibility Test Discs, Antimicrobial
90d
Not Cleared
Jun 06, 2023
Cue COVID-19 Molecular Test
QWB
Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens
400d
Cleared
Jun 01, 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
QQX
Respiratory Specimen Nucleic Acid Sars-cov-2 Test
27d
Cleared
Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
JTN
Susceptibility Test Discs, Antimicrobial
66d
Cleared
May 18, 2023
ComASP Cefiderocol 0.008-128
JWY
Manual Antimicrobial Susceptibility Test Systems
85d
Cleared
May 16, 2023
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
QOF
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
249d
Cleared
May 05, 2023
Panther Fusion AdV/hMPV/RV Assay
OCC
Respiratory Virus Panel Nucleic Acid Assay System
25d
Not Cleared
May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
QVP
Sars-cov-2 Serology Test
591d
Not Cleared
May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
QVP
Sars-cov-2 Serology Test
592d
Cleared
May 04, 2023
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
QQY
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
580d
Cleared
May 03, 2023
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
JSM
Culture Media, Non-propagating Transport
611d
Cleared
Apr 26, 2023
Access PCT
PTF
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
210d
Cleared
Apr 19, 2023
Selux AST System
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
681d
Cleared
Apr 17, 2023
Curian® Shiga Toxin
GMZ
Antigens, All Types, Escherichia Coli
210d
Cleared
Apr 13, 2023
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
15d
Cleared
Apr 13, 2023
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
QOF
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
29d
Cleared
Apr 05, 2023
BioSci™ Disposable Virus Sampling Tubes
JSM
Culture Media, Non-propagating Transport
90d
Cleared
Apr 05, 2023
MicroScan Prompt Inoculation System-D
LIE
Reagent/device, Inoculum Calibration
317d
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