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
Feb 14, 2020
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
53d
Cleared
Feb 10, 2020
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
OCC
Respiratory Virus Panel Nucleic Acid Assay System
28d
Cleared
Feb 06, 2020
BreathID Smart System
MSQ
Test, Urea (breath Or Blood)
42d
Cleared
Jan 29, 2020
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
LSR
Reagent, Borrelia Serological Reagent
89d
Cleared
Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
JTN
Susceptibility Test Discs, Antimicrobial
36d
Cleared
Jan 08, 2020
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
70d
Cleared
Dec 23, 2019
BioCode Respiratory Pathogen Panel (RPP)
OCC
Respiratory Virus Panel Nucleic Acid Assay System
104d
Cleared
Dec 20, 2019
Unyvero LRT BAL Application
QBH
Lower Respiratory Microbial Nucleic Acid Detection System
150d
Cleared
Dec 11, 2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
OCC
Respiratory Virus Panel Nucleic Acid Assay System
26d
Not Cleared
Dec 05, 2019
cobas vivoDx MRSA
QIV
Culture-based Short-term Incubation Antimicrobial Resistance Assay
261d
Not Cleared
Dec 02, 2019
WOUNDCHEK Bacterial Status
QFA
Assay For Detection Of Proteases In Chronic Wounds
619d
Cleared
Nov 26, 2019
Access PCT, Access PCT Calibrators
PTF
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
96d
Cleared
Nov 26, 2019
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
PGI
Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
88d
Cleared
Nov 26, 2019
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
60d
Cleared
Nov 14, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
77d
Cleared
Nov 12, 2019
xTAG Gastrointestinal Pathogen Panel (GPP)
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
195d
Cleared
Nov 07, 2019
B. anthracis Real-time PCR Assay
NHT
Assay, Nucleic Acid Amplification, Bacillus Anthracis
30d
Cleared
Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
112d
Cleared
Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
111d
Cleared
Nov 06, 2019
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
JWY
Manual Antimicrobial Susceptibility Test Systems
40d
Cleared
Nov 04, 2019
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
187d
Cleared
Oct 31, 2019
Vitek Densichek
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
87d
Cleared
Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
63d
Cleared
Oct 28, 2019
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
QFO
Zika Virus Serological Reagents
89d
Cleared
Oct 21, 2019
BD MAX Vaginal Panel
PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
90d
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