Cleared Traditional

K905211 - VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

K905211 is an FDA 510(k) clearance for VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CD..., manufactured by Vitek Systems, Inc.. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K905211 · Vitek Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
325d
Days
Class 1
Risk

K905211 is an FDA 510(k) clearance for the VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Rockland, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Vitek Systems, Inc. devices

FDA 510(k) Submission Details - K905211

510(k) Number K905211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date October 11, 1991
Days to Decision 325 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 102d · This submission: 325d
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 K905211.
IMMUNOCARD(TM) C. DIFFICILE
K924979 · Meridian Diagnostics, Inc. · Jan 1993
PREMIER C. DIFFICILE TOXIN A CONTROLS
K924136 · Meridian Diagnostics, Inc. · Oct 1992
CLOSTRIDIUM DIFFICILE TOX-A-TEST
K914902 · Techlab, Inc. · Mar 1992
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
K913229 · Baxter Diagnostics, Inc. · Aug 1991
PREMIER-C. DIFFICILE TOXIN A
K903456 · Meridian Diagnostics, Inc. · Oct 1990
CDT CYTOTOXI TEST
K883560 · Advanced Clinical Diagnostics · Oct 1988