DeviceClearance

Product code PCH— Microbiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

Classification name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Device class
Class 2
Regulation
21 CFR 866.3990
Advisory panel
Microbiology
Total cleared
38
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PCH under 21 CFR 866.3990, via openFDA

Market context for product code PCH

FDA has cleared 38 devices under product code PCH between 2013 and 2026, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PCH

Recent clearances under product code PCH

Data sourced from openFDA. This site is unofficial and independent of the FDA.