Cleared Traditional

K931516 - STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALC...

K931516 is the FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALC... by Solarcare Technologies Corp,Inc.. It is a Class 2 Toxicology device (product code DIC) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K931516 · Solarcare Technologies Corp,Inc. · Toxicology device
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Jul 1993
Decision
115d
Days
Class 2
Risk

K931516 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 19, 1993 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Solarcare Technologies Corp,Inc. devices

Submission Details

510(k) Number K931516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date July 19, 1993
Days to Decision 115 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
28d slower than avg
Panel avg: 87d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3040
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 - DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

All 25
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K931516.
OPUS ETHANOL
K972011 · Behring Diagnostics, Inc. · Jul 1997
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
K955633 · Diagnostic Chemicals , Ltd. · May 1996
PARAMAX ALCOHOL REAGENT
K934275 · Baxter Diagnostics, Inc. · Apr 1994
ROCHE REAGENT FOR ETHANOL
K913125 · Roche Diagnostic Systems, Inc. · Aug 1991
DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD
K904302 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
EMIT ETHYL ALCOHOL ASSAY
K903153 · Syva Co. · Aug 1990