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
Apr 01, 2016
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
42d
Cleared
Mar 31, 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
99d
Not Cleared
Mar 28, 2016
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
103d
Cleared
Mar 25, 2016
Great Basin Staph ID/R Blood Culture Panel
PAM
Gram-positive Bacteria And Their Resistance Markers
207d
Cleared
Mar 25, 2016
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
NGZ
Susceptibility Test Plate, Antifungal
256d
Cleared
Mar 22, 2016
Great Basin Shiga Toxin Direct Test
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
167d
Cleared
Mar 17, 2016
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
PLO
Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
27d
Cleared
Mar 15, 2016
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
PEN
Gram-negative Bacteria And Associated Resistance Markers
25d
Cleared
Mar 14, 2016
ImmunoCard STAT! HpSA
LYR
Helicobacter Pylori
84d
Cleared
Mar 11, 2016
chromID MRSA
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
262d
Cleared
Mar 07, 2016
Xpert Carba-R
PMY
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
175d
Cleared
Feb 25, 2016
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
29d
Cleared
Feb 25, 2016
BD BACTEC Peds Plus/F Culture Vials (plastic)
MDB
System, Blood Culturing
231d
Cleared
Feb 24, 2016
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
28d
Not Cleared
Feb 20, 2016
B.R.A.H.M.S PCT sensitive KRYPTOR
PMT
Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
353d
Cleared
Feb 18, 2016
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
NGZ
Susceptibility Test Plate, Antifungal
227d
Cleared
Feb 08, 2016
FilmArray Respiratory Panel (RP) for use with FilmArray Torch
OCC
Respiratory Virus Panel Nucleic Acid Assay System
26d
Cleared
Jan 15, 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
242d
Cleared
Jan 12, 2016
Sofia Influenza A+B FIA
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
90d
Cleared
Dec 22, 2015
ADVIA Centaur Toxoplasma M (Toxo M)
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
448d
Cleared
Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
87d
Cleared
Dec 17, 2015
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
OCC
Respiratory Virus Panel Nucleic Acid Assay System
115d
Cleared
Dec 09, 2015
ProParaFlu+ Assay
OOU
Parainfluenza Multiplex Nucleic Acid Assay
33d
Cleared
Dec 03, 2015
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
OCC
Respiratory Virus Panel Nucleic Acid Assay System
210d
Cleared
Dec 01, 2015
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
32d
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