Cleared Traditional

PROSPECT MICROPLATE ASSAY (K934493) - FDA 510(k) Clearance

Class I Microbiology device.

K934493 · Alexon, Inc. · Microbiology device
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Sep 1994
Decision
370d
Days
Class 1
Risk

K934493 is an FDA 510(k) clearance for the PROSPECT MICROPLATE ASSAY. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Alexon, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 370 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 Alexon, Inc. devices

Submission Details

510(k) Number K934493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1993
Decision Date September 20, 1994
Days to Decision 370 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 102d · This submission: 370d
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 K934493.
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VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
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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