510(k) K214122
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2022
- Date Received
- December 30, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
- Device Class
- Class II
- Regulation Number
- 866.3990
- Review Panel
- MI
- Submission Type
A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial 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.