Cleared Traditional

K102242 - OSOM C. DIFFICILE TOXIN A/B TEST

K102242 is an FDA 510(k) clearance for OSOM C. DIFFICILE TOXIN A/B TEST, manufactured by Genzyme Corporation. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K102242 · Genzyme Corporation · Microbiology device
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Dec 2010
Decision
134d
Days
Class 1
Risk

K102242 is an FDA 510(k) clearance for the OSOM C. DIFFICILE TOXIN A/B TEST. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Genzyme Corporation (Framingham, US). The FDA issued a Cleared decision on December 21, 2010 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Genzyme Corporation devices

FDA 510(k) Submission Details - K102242

510(k) Number K102242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date December 21, 2010
Days to Decision 134 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
32d slower than avg
Panel avg: 102d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

LLH Device Classification - Class 1, General Controls

Product Code LLH Reagents, Clostridium Difficile Toxin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LLH Reagents, Clostridium Difficile Toxin

All 36
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K102242.
SensiTox C. difficile Toxin Test
K193490 · First Light Diagnostics, Inc. · Jul 2021
XPERT C. DIFFICILE
K091109 · Cepheid · Jul 2009
C. DIFF QUIK CHEK COMPLETE
K082499 · Techlab, Inc. · Mar 2009
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · bioMerieux, Inc. · Jun 2008
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · bioMerieux, Inc. · Dec 2007
TOX A/B QUICK CHEK
K050891 · Techlab, Inc. · Jul 2005