Cleared Traditional

PREMIER C. DIFFICILE TOXIN A CONTROLS (K924136) - FDA 510(k) Clearance

Class I Chemistry device.

K924136 · Meridian Diagnostics, Inc. · Chemistry device
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Oct 1992
Decision
62d
Days
Class 1
Risk

K924136 is an FDA 510(k) clearance for the PREMIER C. DIFFICILE TOXIN A CONTROLS. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 19, 1992 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meridian Diagnostics, Inc. devices

Submission Details

510(k) Number K924136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1992
Decision Date October 19, 1992
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
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 41
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K924136.
SensiTox C. difficile Toxin Test
K193490 · First Light Diagnostics, Inc. · Jul 2021
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · bioMerieux, Inc. · Jun 2008
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · bioMerieux, Inc. · Dec 2007
COLORPAC TOXIN A
K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
CULTURETTE BRAND TOXIN CD TEST
K925329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993