Cleared Traditional

K934869 - STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA

K934869 is an FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPIN..., manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K934869 · Solarcare Technologies Corp,Inc. · Toxicology device
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Nov 1993
Decision
41d
Days
Class 2
Risk

K934869 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 22, 1993 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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

FDA 510(k) Submission Details - K934869

510(k) Number K934869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date November 22, 1993
Days to Decision 41 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
46d faster than avg
Panel avg: 87d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 85
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K934869.
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