Cleared Traditional

K214122 - BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel (FDA 510(k) Clearance)

K214122 · Becton, Dickinson and Company · Microbiology device
Jul 2022
Decision
210d
Days
Class 2
Risk

K214122 is an FDA 510(k) clearance for the BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel. 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 July 28, 2022, 210 days after receiving the submission on December 30, 2021.

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 K214122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2021
Decision Date July 28, 2022
Days to Decision 210 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.