Cleared Traditional

K921328 - STC DIAGNOSTICS AUTO-LYTE OPIATE EIA

K921328 is an FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE OPIATE EIA, manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K921328

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.

DJG Device Classification - Class 2, Special Controls

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 195
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