Cleared Traditional

K132726 - ICEPLEX C. DIFFICILE ASSAY KIT

K132726 is the FDA 510(k) clearance for ICEPLEX C. DIFFICILE ASSAY KIT by Primeradx. It is a Class 2 Microbiology device (product code OZN) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K132726 · Primeradx · Microbiology device
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Nov 2013
Decision
91d
Days
Class 2
Risk

K132726 is an FDA 510(k) clearance for the ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM. Classified as C. Difficile Toxin Gene Amplification Assay (product code OZN), Class II - Special Controls.

Submitted by Primeradx (Mansfield, US). The FDA issued a Cleared decision on November 29, 2013 after a review of 91 days - within the typical 510(k) review window.

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: 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 Primeradx devices

Submission Details

510(k) Number K132726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2013
Decision Date November 29, 2013
Days to Decision 91 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
11d faster than avg
Panel avg: 102d · This submission: 91d
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 K132726.
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