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
7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
Cleared
Jun 07, 2017
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
85d
Cleared
Jun 07, 2017
E. HISTOLYTICA QUIK CHEK
KHW
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
90d
Cleared
Jun 01, 2017
ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
PRI
Procalcitonin Assay
90d
Cleared
May 31, 2017
B R A H M S PCT sensitive KRYPTOR
PRI
Procalcitonin Assay
23d
Cleared
May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
JWY
Manual Antimicrobial Susceptibility Test Systems
86d
Cleared
May 30, 2017
FilmArray Respiratory Panel 2 (RP2)
OCC
Respiratory Virus Panel Nucleic Acid Assay System
90d
Cleared
May 25, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
59d
Cleared
May 25, 2017
revogene
OOI
Real Time Nucleic Acid Amplification System
90d
Cleared
May 25, 2017
GenePOC GBS LB
NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
90d
Cleared
May 22, 2017
Strep B Carrot Broth One-Step
PQZ
Gbs Culture Media, Selective And Differential
83d
Cleared
May 19, 2017
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
PUQ
Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
87d
Cleared
May 16, 2017
Strep B Carrot Broth Kit
PQZ
Gbs Culture Media, Selective And Differential
89d
Cleared
May 11, 2017
Solana C. difficile Assay
OZN
C. Difficile Toxin Gene Amplification Assay
83d
Cleared
May 11, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
90d
Cleared
May 02, 2017
BD MAX Extended Enteric Bacterial Panel, BD MAX System
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
90d
Cleared
May 02, 2017
ARIES Bordetella Assay
OZZ
Bordetella Pertussis Dna Assay System
131d
Cleared
May 01, 2017
Remel Spectra ESBL
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
223d
Cleared
Apr 27, 2017
RAPIDEC CARBA NP
PTJ
Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates
245d
Cleared
Apr 18, 2017
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
PTF
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
245d
Cleared
Apr 14, 2017
Sofia Influenza A+B FIA on Sofia 2
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
226d
Cleared
Apr 10, 2017
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
200d
Cleared
Mar 31, 2017
Great Basin Bordetella Direct Test
OZZ
Bordetella Pertussis Dna Assay System
60d
Cleared
Mar 28, 2017
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
MDB
System, Blood Culturing
270d
Cleared
Mar 21, 2017
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
88d
Cleared
Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
LTT
Panels, Test, Susceptibility, Antimicrobial
172d
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