Cleared Traditional

K903456 - PREMIER-C. DIFFICILE TOXIN A

K903456 is the FDA 510(k) clearance for PREMIER-C. DIFFICILE TOXIN A by Meridian Diagnostics, Inc.. It is a Class 1 Toxicology device (product code LLH) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K903456 · Meridian Diagnostics, Inc. · Toxicology device
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Oct 1990
Decision
61d
Days
Class 1
Risk

K903456 is an FDA 510(k) clearance for the PREMIER-C. DIFFICILE TOXIN A. 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 1, 1990 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.2660 - the FDA toxicology 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: 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 K903456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1990
Decision Date October 01, 1990
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 87d · This submission: 61d
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 K903456.
CLOSTRIDIUM DIFFICILE TOX-A-TEST
K914902 · Techlab, Inc. · Mar 1992
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
K905211 · Vitek Systems, Inc. · Oct 1991
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
K913229 · Baxter Diagnostics, Inc. · Aug 1991
CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST
K870864 · Marion Laboratories, Inc. · Apr 1987
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
K863485 · Marion Laboratories, Inc. · Sep 1986
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
K852044 · Marion Laboratories, Inc. · Jul 1985