Cleared Traditional

K934376 - STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA

K934376 is an FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA, manufactured by Solarcare, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K934376 · Solarcare, Inc. · Toxicology device
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Dec 1993
Decision
89d
Days
Class 2
Risk

K934376 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Solarcare, Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 7, 1993 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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, Inc. devices

FDA 510(k) Submission Details - K934376

510(k) Number K934376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1993
Decision Date December 07, 1993
Days to Decision 89 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
2d slower than avg
Panel avg: 87d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 92
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K934376.
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404 · Microgenics Corp. · Jul 1994
ACE CLINICAL CHEMISTRY SYSTEM
K941489 · Schiapparelli Biosystems, Inc. · Jul 1994
CEDIA DAU BARBITURATE ASSAY
K936030 · Microgenics Corp. · Mar 1994
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · Syva Co. · Jun 1993
EMIT(R) II BARBITURATE ASSAY
K926068 · Syva Co. · Jan 1993
BARBITURATE EIA TEST
K925491 · Diagnostic Reagents, Inc. · Dec 1992