Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
The Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System is a qualitative in vitro diagnostic assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of infections associated with orthopedic implants and procedures. It uses nucleic acid amplification technology to simultaneously identify multiple pathogens in a single test. Classified as FDA Class 2 under regulation 866.3988, it requires 510(k) clearance in the Microbiology specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QSN
- Device Class
- FDA class 2
- Regulation Number
- 866.3988
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200066 | BioFire Joint Infection (JI) Panel | Apr 29, 2022 | Unknown | Biofire Diagnostics, LLC |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.