Cleared Traditional

K053572 - C. DIFF QUIK CHEK (FDA 510(k) Clearance)

Class I Microbiology device.

K053572 · Techlab, Inc. · Microbiology device
Apr 2006
Decision
125d
Days
Class 1
Risk

K053572 is an FDA 510(k) clearance for the C. DIFF QUIK CHEK. This device is classified as a Antigen, C. Difficile (Class I - General Controls, product code MCB).

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 26, 2006, 125 days after receiving the submission on December 22, 2005.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K053572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2005
Decision Date April 26, 2006
Days to Decision 125 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 174d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MCB Antigen, C. Difficile
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.