Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
PCH · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3990
Classification
FDA Product Code
PCH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3990
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.