FDA product code PCI: Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
PCI is the FDA product code for gastrointestinal bacterial 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 5 510(k) submissions under PCI, 2 in the last five years, from 3 different applicants. The average 510(k) review took 203 days (median 210); 266 days on average over the last three years.
Definition
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 the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Gastrointestinal Bacterial 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 PCI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 205 |
| 2018 | 1 | 221 |
| 2022 | 1 | 210 |
| 2025 | 1 | 266 |
Compare with all 510(k) review times · Search every PCI clearance
Top PCI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson and Company | 3 | 2025-10-31 |
| Micronics, Inc. | 1 | 2018-06-01 |
| Great Basin Scientific, Inc. | 1 | 2017-07-12 |
Most recent PCI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250358 | Becton, Dickinson and Company | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | 2025-10-31 | 266 |
| K214122 | Becton, Dickinson and Company | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | 2022-07-28 | 210 |
| K173330 | Micronics, Inc. | PanNAT STEC Test | 2018-06-01 | 221 |
| K163571 | Great Basin Scientific, Inc. | Great Basin Stool Bacterial Pathogens Panel | 2017-07-12 | 205 |
| K140111 | Becton, Dickinson and Company | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT | 2014-05-06 | 111 |
Recalls for PCI devices
openFDA lists no recalls for product code PCI.
Frequently asked questions
What is FDA product code PCI?
PCI is the FDA product code for gastrointestinal bacterial 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 PCI?
Class II, regulation 21 CFR 866.3990. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCI?
Across 5 cleared submissions the average was 203 days from receipt to decision (median 210).
Which companies have the most PCI clearances?
Becton, Dickinson and Company (3); Micronics, Inc. (1); Great Basin Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCI
- Run a recall and safety report across every PCI manufacturer
- Watch product code PCI 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.
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