Cleared Traditional

K921328 - STC DIAGNOSTICS AUTO-LYTE OPIATE EIA

K921328 is the FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE OPIATE EIA by Solarcare Technologies Corp,Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K921328 · Solarcare Technologies Corp,Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
155d
Days
Class 2
Risk

K921328 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE OPIATE EIA. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 20, 1992 after a review of 155 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 K921328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1992
Decision Date August 20, 1992
Days to Decision 155 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
68d slower than avg
Panel avg: 87d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 147
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K921328.
CEDIA(R) DAU OPIATE ASSAY
K935346 · Microgenics Corp. · Jan 1994
EMIT(R) IIC OPIATE ASSAY
K935117 · Syva Co. · Jan 1994
MICRO-PLATE OPIATES ASSAY
K924446 · Solarcare Technologies Corp,Inc. · Oct 1992
OPIATE EIA ASSAY
K915180 · Diagnostic Reagents, Inc. · Jan 1992
IL TEST(TM) OPIATE
K913742 · Instrumentation Laboratory CO · Nov 1991
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K913863 · Immunalysis Corporation · Sep 1991