510(k) K242367
K242367 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC for the device "BIOFIRE FILMARRAY Gastrointestinal (GI) Panel". The FDA issued a decision of Substantially Equivalent on November 7, 2024. The device falls under product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System), a Class II device regulated under 21 CFR 866.3990. Biofire Diagnostics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2024
- Date Received
- August 9, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device Class
- Class II
- Regulation Number
- 866.3990
- Review Panel
- MI
- Submission Type
A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.