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
7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5925 Microbiology devices
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
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
60d
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
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 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
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 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
111d
Cleared
Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
112d
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
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
63d
Cleared
Oct 31, 2019
Vitek Densichek
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
87d
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
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
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