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
Aug 12, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
NOP
Elisa, Antibody, West Nile Virus
269d
Cleared
Aug 10, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
NOP
Elisa, Antibody, West Nile Virus
268d
Cleared
Aug 08, 2016
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
MDB
System, Blood Culturing
90d
Cleared
Aug 02, 2016
ARIES® Flu A/B & RSV Assay
OCC
Respiratory Virus Panel Nucleic Acid Assay System
95d
Cleared
Jul 29, 2016
Puritan Opti-Tranz Cary-Blair Collection and Transport System
JSM
Culture Media, Non-propagating Transport
196d
Cleared
Jul 28, 2016
Elecsys Syphilis
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
118d
Cleared
Jul 25, 2016
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
OCC
Respiratory Virus Panel Nucleic Acid Assay System
227d
Cleared
Jul 22, 2016
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
LYR
Helicobacter Pylori
91d
Cleared
Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
79d
Cleared
Jul 12, 2016
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
77d
Cleared
Jul 05, 2016
Lumipulse G TP-N Immunoreaction Cartridge Set
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
249d
Cleared
Jun 30, 2016
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
24d
Cleared
Jun 30, 2016
LIAISON CMV IgM Serum Control Set
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Jun 30, 2016
LIAISON EBV IgM Serum Control Set
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
OOI
Real Time Nucleic Acid Amplification System
29d
Cleared
Jun 29, 2016
Xpert Carba-R
POC
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
89d
Cleared
Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
PMT
Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
88d
Cleared
Jun 22, 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
JWY
Manual Antimicrobial Susceptibility Test Systems
190d
Cleared
Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
170d
Cleared
Jun 13, 2016
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
OZX
Mycoplasma Pneumoniae Dna Assay System
80d
Cleared
Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
PMT
Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
89d
Cleared
May 13, 2016
SeraQuest HSV Type 2 Specific IgG
MYF
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
267d
Cleared
May 10, 2016
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
235d
Cleared
Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
263d
Cleared
Apr 12, 2016
ARIES System
OOI
Real Time Nucleic Acid Amplification System
48d
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