Cleared Traditional

K964887 - VIDAS C. DIFFICILE TOXIN A II ASSAY

K964887 is the FDA 510(k) clearance for VIDAS C. DIFFICILE TOXIN A II ASSAY by Biomerieux Vitek, Inc.. It is a Class 1 Microbiology device (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

Submission Details

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.

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 K964887.
PREMIER TOXINS A&B, MODEL 616096
K993914 · Meridian Diagnostics, Inc. · Dec 1999
COLORPAC TOXIN A
K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
TOX A/B TEST
K971182 · Techlab, Inc. · Jul 1997
IMMUNOCARD TOXIN A
K955859 · Meridian Diagnostics, Inc. · Apr 1996
CLOSTRIDIUM DIFFICILE TOX-B TEST
K935296 · Techlab, Inc. · Apr 1994
TECHLAB 1-HOUR TOX-A-TEST
K931129 · Techlab, Inc. · Sep 1993