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
4573 Microbiology devices
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 17, 2019
Fungitell STAT
NQZ
Antigen, Invasive Fungal Pathogens
77d
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
Cleared
Jun 25, 2019
Cepheid Xpert SA Nasal Complete Control Panel
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
55d
Cleared
Jun 20, 2019
Campylobacter Quik Chek
LQP
Campylobacter Spp.
20d
Cleared
Jun 20, 2019
Campylobacter Chek
LQP
Campylobacter Spp.
21d
Cleared
Jun 20, 2019
Cepheid Xpert MRSA NxG Control Panel
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
50d
Cleared
Jun 19, 2019
EntericBio Dx Assay
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
265d
Cleared
Jun 13, 2019
SeraQuest HSV Type 2 Specific IgG
MYF
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
370d
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
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