FDA product code · Microbiology
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
5 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 238 days (half between 224 and 252). No recall names this code. The most-cited predicate is K140111, named by 3 later devices.
A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PCI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PCI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PCI
Too few PCI 510(k)s in any year since 2007 to give a median.
Recalls per year · PCI
No recall names PCI since 2007.
Adverse event reports per year · PCI
7in 2025
MAUDE reports naming product code PCI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
Planning a device in PCI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 866.3990.