Cleared Traditional

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 (FDA 510(k) Clearance)

K250358 · Becton, Dickinson and Company · Microbiology device
Oct 2025
Decision
266d
Days
Class 2
Risk

K250358 is an FDA 510(k) clearance for the 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. This device is classified as a Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System (Class II - Special Controls, product code PCI).

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on October 31, 2025, 266 days after receiving the submission on February 7, 2025.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3990. 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..

Submission Details

510(k) Number K250358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2025
Decision Date October 31, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PCI — Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.3990
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.