Cleared Traditional

K181427 - BD MAX Enteric Viral Panel

K181427 is an FDA 510(k) clearance for BD MAX Enteric Viral Panel, manufactured by Becton, Dickinson and Company. The device is a Class 2 Microbiology device with product code PCH cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K181427 · Becton, Dickinson and Company · Microbiology device
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Nov 2018
Decision
181d
Days
Class 2
Risk

K181427 is an FDA 510(k) clearance for the BD MAX Enteric Viral Panel, BD MAX Instrument. Classified as Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (product code PCH), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on November 29, 2018 after a review of 181 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.

View all Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K181427

510(k) Number K181427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2018
Decision Date November 29, 2018
Days to Decision 181 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
79d slower than avg
Panel avg: 102d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PCH Device Classification - Class 2, Special Controls

Product Code PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3990
Definition A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial 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.

Regulatory Peers - PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

All 32
Devices cleared under the same product code (PCH) and FDA review panel - the closest regulatory comparables to K181427.
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xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
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BioCode Gastrointestinal Pathogen Panel (GPP)
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