FDA product code PCH: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
PCH is the FDA product code for gastrointestinal pathogen panel multiplex nucleic acid-based assay system. It is a Class II device, regulated under 21 CFR 866.3990 and reviewed by the Microbiology panel. FDA has cleared 36 510(k) submissions under PCH, 15 in the last five years, from 15 different applicants. The average 510(k) review took 154 days (median 104); 211 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 24 recalls for PCH devices, 13 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System |
| Device class | Class II |
| Regulation | 21 CFR 866.3990 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PCH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2018 | 4 | 126 |
| 2019 | 4 | 184 |
| 2022 | 2 | 205 |
| 2023 | 1 | 29 |
| 2024 | 3 | 411 |
| 2025 | 7 | 67 |
| 2026 | 2 | 154 |
Top PCH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luminex Molecular Diagnostics, Inc. | 7 | 2019-11-12 |
| QIAGEN GmbH | 5 | 2026-03-09 |
| Biofire Diagnostics, LLC | 5 | 2025-01-16 |
| Becton, Dickinson and Company | 5 | 2022-09-21 |
| Applied BioCode, Inc. | 3 | 2025-01-10 |
10 more applicants have PCH clearances. See the full list in Caduvo.
Most recent PCH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254032 | QIAGEN GmbH | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | 2026-03-09 | 83 |
| K251721 | Cepheid | Xpert GI Panel | 2026-01-16 | 226 |
| K252329 | QIAGEN GmbH | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | 2025-10-22 | 89 |
| K251993 | Hologic, Inc. | Panther Fusion GI Expanded Bacterial Assay | 2025-09-25 | 90 |
| K251868 | Hologic | Panther Fusion GI Bacterial Assay | 2025-09-25 | 99 |
Recalls for PCH devices
24 product recalls in 17 recall events; 13 initiated in the last five years and 16 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 7 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 5 |
| 2024 | 2 |
| 2025 | 5 |
Frequently asked questions
What is FDA product code PCH?
PCH is the FDA product code for gastrointestinal pathogen panel multiplex nucleic acid-based assay system. It is a Class II device, regulated under 21 CFR 866.3990 and reviewed by the Microbiology panel.
What device class is PCH?
Class II, regulation 21 CFR 866.3990. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCH?
Across 36 cleared submissions the average was 154 days from receipt to decision (median 104).
Which companies have the most PCH clearances?
Luminex Molecular Diagnostics, Inc. (7); QIAGEN GmbH (5); Biofire Diagnostics, LLC (5); Becton, Dickinson and Company (5); Applied BioCode, Inc. (3).
Have PCH devices been recalled?
Yes: 24 product recalls across 17 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code PCH
- Run a recall and safety report across every PCH manufacturer
- Watch product code PCH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.