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
Dec 13, 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
30d
Cleared
Dec 12, 2017
T2Candida 1.1 Panel
PII
Candida Species Nucleic Acid Detection System
27d
Cleared
Dec 10, 2017
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
LSR
Reagent, Borrelia Serological Reagent
90d
Cleared
Dec 10, 2017
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set
PRI
Procalcitonin Assay
93d
Cleared
Dec 08, 2017
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
88d
Cleared
Dec 07, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)
LTT
Panels, Test, Susceptibility, Antimicrobial
73d
Cleared
Dec 04, 2017
Panther Fusion AdV/hMPV/RV Assay
OCC
Respiratory Virus Panel Nucleic Acid Assay System
94d
Cleared
Dec 01, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
60d
Cleared
Dec 01, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
LTT
Panels, Test, Susceptibility, Antimicrobial
128d
Not Cleared
Nov 29, 2017
GeneSTAT.MDx Coccidioides Assay
QAA
Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
120d
Cleared
Nov 24, 2017
FilmArray RP2/RP2plus Control Panel
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
56d
Not Cleared
Nov 24, 2017
FilmArray Respiratory Panel 2 plus (RP2plus)
PZF
Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
253d
Cleared
Nov 22, 2017
GenePOC CDiff
OZN
C. Difficile Toxin Gene Amplification Assay
89d
Cleared
Oct 30, 2017
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
PGX
Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
82d
Cleared
Oct 23, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
JWY
Manual Antimicrobial Susceptibility Test Systems
61d
Cleared
Oct 23, 2017
Panther Fusion Paraflu Assay
OOU
Parainfluenza Multiplex Nucleic Acid Assay
87d
Cleared
Oct 23, 2017
Lyme B. burgdorferi (IgM) MarStripe Test
LSR
Reagent, Borrelia Serological Reagent
89d
Cleared
Oct 20, 2017
Sofia Lyme FIA, Sofia Lyme Control Set
LSR
Reagent, Borrelia Serological Reagent
294d
Cleared
Oct 16, 2017
Solana RSV+hMPV Assay
OCC
Respiratory Virus Panel Nucleic Acid Assay System
108d
Cleared
Oct 13, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
60d
Cleared
Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
JTN
Susceptibility Test Discs, Antimicrobial
33d
Cleared
Sep 29, 2017
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
OCC
Respiratory Virus Panel Nucleic Acid Assay System
105d
Cleared
Sep 27, 2017
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
JWY
Manual Antimicrobial Susceptibility Test Systems
76d
Cleared
Sep 26, 2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
OCC
Respiratory Virus Panel Nucleic Acid Assay System
88d
Cleared
Sep 25, 2017
Xpert Xpress Strep A
PGX
Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
73d
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