PCI · Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Microbiology · 21 CFR 866.3990 · Class 2
Overview
| Product Code | PCI |
|---|---|
| Device Name | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System |
| Regulation | 21 CFR 866.3990 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
A gastrointestinal microorganism multiplex nucleic acid-based 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 device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.
Classification Rationale
Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).
Special Controls
*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250358 | 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 | Becton, Dickinson and Company | Oct 31, 2025 | SESE |
| K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | Becton, Dickinson and Company | Jul 28, 2022 | SESE |
| K173330 | PanNAT STEC Test | Micronics, Inc. | Jun 1, 2018 | SESE |
| K163571 | Great Basin Stool Bacterial Pathogens Panel | Great Basin Scientific, Inc. | Jul 12, 2017 | SESE |
| K140111 | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT | Becton, Dickinson and Company | May 6, 2014 | SESE |
Top Applicants
- Becton, Dickinson and Company — 3 clearances
- Great Basin Scientific, Inc. — 1 clearance
- Micronics, Inc. — 1 clearance
