Cleared Traditional

K944372 - STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA

K944372 is an FDA 510(k) clearance for STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA, manufactured by Solarcare, Inc.. The device is a Class 2 Toxicology device with product code JXN cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K944372 · Solarcare, Inc. · Toxicology device
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Feb 1995
Decision
154d
Days
Class 2
Risk

K944372 is an FDA 510(k) clearance for the STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Solarcare, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 154 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3700 - 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, Inc. devices

FDA 510(k) Submission Details - K944372

510(k) Number K944372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1994
Decision Date February 08, 1995
Days to Decision 154 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
67d slower than avg
Panel avg: 87d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXN Device Classification - Class 2, Special Controls

Product Code JXN Enzyme Immunoassay, Propoxyphene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3700
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 - JXN Enzyme Immunoassay, Propoxyphene

All 21
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K944372.
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
K983700 · Roche Diagnostic Systems, Inc. · Dec 1998
SYNCHRON SYSTEMS PROPOXYPHENE REAGENT
K955675 · Beckman Instruments, Inc. · Feb 1996
CEDIA DAU PROPOXYPHENE ASSAY
K951133 · Microgenics Corp. · May 1995
ABUSCREEN ONLINE PROPOXPHENE
K945195 · Roche Diagnostic Systems, Inc. · Dec 1994
PROPOXPHENE EIA TEST
K943414 · Diagnostic Reagents, Inc. · Sep 1994
SYVA EMIT II PROPOXYPHENE ASSAY
K923873 · Syva Co. · Nov 1992