Cleared Traditional

K091109 - XPERT C. DIFFICILE

K091109 is the FDA 510(k) clearance for XPERT C. DIFFICILE by Cepheid. It is a Class 1 Microbiology device (product code LLH) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K091109 · Cepheid · Microbiology device
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Jul 2009
Decision
84d
Days
Class 1
Risk

K091109 is an FDA 510(k) clearance for the XPERT C. DIFFICILE. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on July 9, 2009 after a review of 84 days - a notably fast clearance cycle.

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: 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 Cepheid devices

Submission Details

510(k) Number K091109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2009
Decision Date July 09, 2009
Days to Decision 84 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
18d faster than avg
Panel avg: 102d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 29
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K091109.
SensiTox C. difficile Toxin Test
K193490 · First Light Diagnostics, Inc. · Jul 2021
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
IMMUNOCARD TOXINS A & B, MODEL 712050
K041003 · Meridian Bioscience, Inc. · Aug 2004