Cleared Traditional

K032897 - C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL

Also marketed or referenced as:
CDIFF-96

K032897 is an FDA 510(k) clearance for C. DIFFICILE TOXIN A + B FECAL ANTIGEN ..., manufactured by Ivd Research, Inc.. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K032897 · Ivd Research, Inc. · Microbiology device
Download Printable Device Report (PDF)
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May 2004
Decision
253d
Days
Class 1
Risk

K032897 is an FDA 510(k) clearance for the C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Ivd Research, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 27, 2004 after a review of 253 days - an extended review 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: 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 Ivd Research, Inc. devices

FDA 510(k) Submission Details - K032897

510(k) Number K032897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date May 27, 2004
Days to Decision 253 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 102d · This submission: 253d
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 K032897.
TOX A/B QUICK CHEK
K050891 · Techlab, Inc. · Jul 2005
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
K041951 · Remel, Inc. · Nov 2004
IMMUNOCARD TOXINS A & B, MODEL 712050
K041003 · Meridian Bioscience, Inc. · Aug 2004
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479 · Remel, Inc. · Feb 2004
C. DIFF CHEK - 30
K030991 · Techlab, Inc. · Jul 2003
C. DIFF CHEK - 60
K030992 · Techlab, Inc. · Jul 2003