# PCI: Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

- Device class: 2; regulation: 21 CFR 866.3990; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 238 days (middle half 224–252)
- Recalls: 0 (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)
- 2014: 1
- 2017: 1
- 2018: 1
- 2022: 1
- 2025: 1

## Most-cited predicates
- K140111: BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument (2014), cited by 3
- K214122: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel (2022), cited by 1

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