510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PCHClass II

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

21 CFR 866.3990 / Microbiology
FDA source (opens on fda.gov)

PCH is the FDA product code for Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a class II device type, regulated under 21 CFR 866.3990. FDA's definition for this code reads: "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...". As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 24 recalls.

Classification record

Product code
PCH
Device name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
FDA 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.
Regulation
21 CFR 866.3990
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
38
Ingested recalls
24

Clearances, product code PCH

By decision year
38 clearances under product code PCH with a decision year between 2013 and 2026, 2025 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code PCH by decision year
YearClearances
20133
20146
20152
20162
20171
20184
20194
20222
20231
20243
20257
20263

Applicants with the most clearances

Product code PCH
Applicants holding the most 510(k) clearances under product code PCH
ApplicantClearances
Luminex Molecular Diagnostics Inc8
BioFire Diagnostics, LLC6
Becton Dickinson & Co5
Qiagen5
Applied BioCode, Inc.3
Cepheid2
Hologic, Inc.2
Luminex Corporation2
Gen-Probe Prodesse, Inc.1
Genetic Signatures Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order