Cleared Traditional

K123998 - QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY

K123998 is an FDA 510(k) clearance for QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY, manufactured by Quidel Corp.. The device is a Class 2 Microbiology device with product code OZN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K123998 · Quidel Corp. · Microbiology device
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Mar 2013
Decision
72d
Days
Class 2
Risk

K123998 is an FDA 510(k) clearance for the QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY. Classified as C. Difficile Toxin Gene Amplification Assay (product code OZN), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 72 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 Quidel Corp. devices

FDA 510(k) Submission Details - K123998

510(k) Number K123998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date March 08, 2013
Days to Decision 72 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
30d faster than avg
Panel avg: 102d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OZN Device Classification - Class 2, Special Controls

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 10
Devices cleared under the same product code (OZN) and FDA review panel - the closest regulatory comparables to K123998.
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
AMPLIVUE C. DIFFICILE ASSAY
K123355 · Quidel Corporation · Dec 2012
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
K123197 · Nanosphere, Inc. · Dec 2012