Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (K950308) - FDA 510(k) Clearance

Class I Toxicology device.

K950308 · Solarcare Technologies Corp,Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
79d
Days
Class 1
Risk

K950308 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA. Classified as Block, Cutting, Ent, Sterile (product code JXS), Class I - General Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 14, 1995 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 874.3540 - 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: 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 K950308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1995
Decision Date April 14, 1995
Days to Decision 79 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
8d faster than avg
Panel avg: 87d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXS Block, Cutting, Ent, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3540
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.