Cleared Traditional

K964887 - VIDAS C. DIFFICILE TOXIN A II ASSAY

K964887 is an FDA 510(k) clearance for VIDAS C. DIFFICILE TOXIN A II ASSAY, manufactured by Biomerieux Vitek, Inc.. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K964887 · Biomerieux Vitek, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
123d
Days
Class 1
Risk

K964887 is an FDA 510(k) clearance for the VIDAS C. DIFFICILE TOXIN A II ASSAY. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on April 8, 1997 after a review of 123 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 Biomerieux Vitek, Inc. devices

FDA 510(k) Submission Details - K964887

510(k) Number K964887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1996
Decision Date April 08, 1997
Days to Decision 123 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
21d slower than avg
Panel avg: 102d · This submission: 123d
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 35
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K964887.
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K964864 · Alexon Biomedical, Inc. · Feb 1997
IMMUNOCARD TOXIN A
K955859 · Meridian Diagnostics, Inc. · Apr 1996
CLOSTRIDIUM DIFFICILE TOX-B TEST
K935296 · Techlab, Inc. · Apr 1994