Cleared Traditional

K130470 - BD MAX CDIFF ASSAY

K130470 is the FDA 510(k) clearance for BD MAX CDIFF ASSAY by Geneohm Sciences Canada, Inc. (Bd Diagnostics). It is a Class 2 Microbiology device (product code OZN) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K130470 · Geneohm Sciences Canada, Inc. (Bd Diagnostics) · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
36d
Days
Class 2
Risk

K130470 is an FDA 510(k) clearance for the BD MAX CDIFF ASSAY, BD MAX INSTRUMENT. Classified as C. Difficile Toxin Gene Amplification Assay (product code OZN), Class II - Special Controls.

Submitted by Geneohm Sciences Canada, Inc. (Bd Diagnostics) (Quebec, CA). The FDA issued a Cleared decision on April 2, 2013 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3130 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Geneohm Sciences Canada, Inc. (Bd Diagnostics) devices

Submission Details

510(k) Number K130470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2013
Decision Date April 02, 2013
Days to Decision 36 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 102d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OZN C. Difficile Toxin Gene Amplification Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3130
Definition Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.
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 - OZN C. Difficile Toxin Gene Amplification Assay

All 9
Devices cleared under the same product code (OZN) and FDA review panel - the closest regulatory comparables to K130470.
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770 · Roche Molecular Systems, Inc. · Sep 2017
Solana C. difficile Assay
K170491 · Quidel Corporation · May 2017
cobas Cdiff Test
K142422 · Roche Molecular Systems, Inc. · May 2015
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
K123998 · Quidel Corp. · Mar 2013
AMPLIVUE C. DIFFICILE ASSAY
K123355 · Quidel Corporation · Dec 2012