# PCH: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

- Device class: 2; regulation: 21 CFR 866.3990; FDA's rule: 510(k) required
- FDA decisions: 38
- 510(k) review time 2021–2025: median 90 days (middle half 29–203)
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 2
- 2016: 2
- 2017: 1
- 2018: 4
- 2019: 4
- 2022: 2
- 2023: 1
- 2024: 3
- 2025: 7
- 2026: 3

## Most-cited predicates
- K140407: Filmarray Gastrointestinal (GI) Panel (2014), cited by 8
- DEN130003: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas) (2013), cited by 5
- K121894: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas GPP) Luminex Magpix (2013), cited by 4
- K160459: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (2016), cited by 4
- K143005: FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (2015), cited by 4
- K220062: QIAstat-Dx Gastrointestinal Panel 2 (2024), cited by 3
- K242367: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (2024), cited by 2
- K143648: BD MAX Enteric Parasite Panel, BD MAX Instrument (2015), cited by 2
- K170308: BD MAX Extended Enteric Bacterial Panel, BD MAX System (2017), cited by 2
- K180041: BioCode Gastrointestinal Pathogen Panel (GPP) (2018), cited by 1

Source page: https://510kreport.com/product-code/PCH
Data by year (CSV): https://510kreport.com/product-code/PCH.csv