Cleared Traditional

K921140 - STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA

K921140 is an FDA 510(k) clearance for STC DIAGNOSTICS AUTO0LYTE COCAINE METAB..., manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 Toxicology device with product code JXO cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K921140 · Solarcare Technologies Corp,Inc. · Toxicology device
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Aug 1992
Decision
163d
Days
Class 2
Risk

K921140 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA. Classified as Enzyme Immunoassay, Cocaine (product code JXO), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 20, 1992 after a review of 163 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Solarcare Technologies Corp,Inc. devices

FDA 510(k) Submission Details - K921140

510(k) Number K921140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1992
Decision Date August 20, 1992
Days to Decision 163 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 87d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXO Device Classification - Class 2, Special Controls

Product Code JXO Enzyme Immunoassay, Cocaine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - JXO Enzyme Immunoassay, Cocaine

Devices cleared under the same product code (JXO) and FDA review panel - the closest regulatory comparables to K921140.
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K915785 · Solarcare Technologies Corp,Inc. · Mar 1992
IL TEST(TM) COCAINE
K913737 · Instrumentation Laboratory CO · Dec 1991