Cleared Traditional

K934493 - PROSPECT MICROPLATE ASSAY

K934493 is an FDA 510(k) clearance for PROSPECT MICROPLATE ASSAY, manufactured by Alexon, Inc.. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 370-day FDA review.

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

FDA 510(k) Submission Details - K934493

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.

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 37
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K934493.
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · Biomerieux Vitek, Inc. · Apr 1997
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
K964864 · Alexon Biomedical, Inc. · Feb 1997
IMMUNOCARD TOXIN A
K955859 · Meridian Diagnostics, Inc. · Apr 1996
CLOSTRIDIUM DIFFICILE TOX-B TEST
K935296 · Techlab, Inc. · Apr 1994
TECHLAB 1-HOUR TOX-A-TEST
K931129 · Techlab, Inc. · Sep 1993
CULTURETTE BRAND TOXIN CD TEST
K925329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993