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
5926 Microbiology devices
Cleared
Jun 06, 2019
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
87d
Cleared
Jun 05, 2019
Biocode Gastrointestinal Pathogen Panel (GPP)
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
91d
Cleared
May 29, 2019
MTS Doxycycline 0.016 - 256 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
51d
Cleared
May 23, 2019
Aptima Combo 2 Assay (Panther System)
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
83d
Cleared
May 23, 2019
Aptima BV Assay
PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
87d
Cleared
May 23, 2019
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
87d
Not Cleared
May 23, 2019
ZIKV Detect 2.0 IgM Capture ELISA
QFO
Zika Virus Serological Reagents
148d
Not Cleared
May 23, 2019
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
QGN
Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
328d
Cleared
May 22, 2019
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
89d
Cleared
May 18, 2019
QIAstat-Dx Respiratory Panel
OCC
Respiratory Virus Panel Nucleic Acid Assay System
148d
Cleared
May 16, 2019
Aptima CV/TV Assay
PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
79d
Cleared
May 15, 2019
BACT/ALERT MP Reagent System
MDB
System, Blood Culturing
85d
Cleared
May 15, 2019
APAS Independence with Urine Analysis Module
PPU
Microbial Colony Image Assessment System
140d
Cleared
May 13, 2019
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
PLO
Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
98d
Cleared
May 10, 2019
GenePOC Carba
PMY
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
91d
Cleared
May 08, 2019
Cepheid Xpert CT/NG Control Panel
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
92d
Cleared
May 03, 2019
FilmArray Pneumonia/Pneumoniaplus Control
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
87d
Cleared
May 01, 2019
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
91d
Cleared
Apr 29, 2019
HardyCHROM CRE
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
55d
Cleared
Apr 25, 2019
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
30d
Cleared
Apr 22, 2019
FluChip-8G Influenza A+B Assay
OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
222d
Cleared
Apr 19, 2019
Cepheid Xpert C. difficile/Epi Control Panel
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
52d
Cleared
Apr 18, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
85d
Cleared
Apr 12, 2019
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
PEN
Gram-negative Bacteria And Associated Resistance Markers
200d
Cleared
Mar 27, 2019
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit
OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
43d
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