Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
The Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System is a qualitative in vitro diagnostic device designed to detect and identify bacterial pathogens specifically from gastrointestinal specimens. It falls under the Microbiology medical specialty and is classified as a Class 2 device under regulation 866.3990, requiring 510(k) premarket notification. By targeting bacterial organisms, this panel complements broader GI pathogen panels and supports targeted antimicrobial therapy decisions. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PCI
- Device Class
- FDA class 2
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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 | Oct 31, 2025 | Substantially Equivalent | Becton, Dickinson and Company |
| K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | Jul 28, 2022 | Substantially Equivalent | Becton, Dickinson and Company |
| K173330 | PanNAT STEC Test | Jun 01, 2018 | Substantially Equivalent | Micronics, Inc. |
| K163571 | Great Basin Stool Bacterial Pathogens Panel | Jul 12, 2017 | Substantially Equivalent | Great Basin Scientific, Inc. |
| K140111 | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT | May 06, 2014 | Substantially Equivalent | Becton, Dickinson and Company |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.