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)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250358 · Becton, Dickinson and Company · Microbiology device
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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.... Classified as Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System (product code PCI), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on October 31, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3990 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 102d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.