Cleared Traditional

K915785 - STC DIAGNOSTICS BENZOYLECGONINE EIA

K915785 is the FDA 510(k) clearance for STC DIAGNOSTICS BENZOYLECGONINE EIA by Solarcare Technologies Corp,Inc.. It is a Class 2 Chemistry device (product code JXO) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K915785 · Solarcare Technologies Corp,Inc. · Chemistry device
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Mar 1992
Decision
78d
Days
Class 2
Risk

K915785 is an FDA 510(k) clearance for the STC DIAGNOSTICS BENZOYLECGONINE 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 March 11, 1992 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3250 - 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 Solarcare Technologies Corp,Inc. devices

Submission Details

510(k) Number K915785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date March 11, 1992
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.