Cleared Traditional

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

K250358 · Becton, Dickinson and Company · Microbiology

Oct 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

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, 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 review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K250358 FDA.gov
FDA Decision	Cleared 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.