Cleared Traditional

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel

K214122 · Becton, Dickinson and Company · Microbiology

Jul 2022

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K214122 is an FDA 510(k) clearance for the BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel, 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 review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K214122 FDA.gov
FDA Decision	Cleared 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.