Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA (K924462) - FDA 510(k) Clearance

K924462 · Solarcare Technologies Corp,Inc. · Toxicology device
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Nov 1992
Decision
61d
Days
-
Risk

K924462 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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 K924462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1992
Decision Date November 02, 1992
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 87
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