Cleared Traditional

K140111 - BD MAX(TM) ENTERIC BACTERIAL PANEL (FDA 510(k) Clearance)

Also includes:
BD MAX(TM) INSTRUMENT
K140111 · Becton, Dickinson and Company · Microbiology device
May 2014
Decision
111d
Days
Class 2
Risk

K140111 is an FDA 510(k) clearance for the BD MAX(TM) 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 May 6, 2014, 111 days after receiving the submission on January 15, 2014.

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 K140111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2014
Decision Date May 06, 2014
Days to Decision 111 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.