Cleared Traditional

K030991 - C. DIFF CHEK - 30

K030991 is an FDA 510(k) clearance for C. DIFF CHEK - 30, manufactured by Techlab, Inc.. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K030991 · Techlab, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
105d
Days
Class 1
Risk

K030991 is an FDA 510(k) clearance for the C. DIFF CHEK - 30. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on July 11, 2003 after a review of 105 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 Techlab, Inc. devices

FDA 510(k) Submission Details - K030991

510(k) Number K030991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2003
Decision Date July 11, 2003
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 102d · This submission: 105d
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 K030991.
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 - 60
K030992 · Techlab, Inc. · Jul 2003
C. DIFFICILE TOX A/B II
K030404 · Techlab, Inc. · Apr 2003
C. DIFFICILE TOX A/B II
K003306 · Techlab, Inc. · Nov 2000