Cleared Traditional

K944056 - AUTO-LYTE METHADONE DIA

K944056 is an FDA 510(k) clearance for AUTO-LYTE METHADONE DIA, manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K944056 · Solarcare Technologies Corp,Inc. · Toxicology device
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Dec 1994
Decision
132d
Days
Class 2
Risk

K944056 is an FDA 510(k) clearance for the AUTO-LYTE METHADONE DIA. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 - K944056

510(k) Number K944056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1994
Decision Date December 29, 1994
Days to Decision 132 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
45d slower than avg
Panel avg: 87d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJR Device Classification - Class 2, Special Controls

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 58
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K944056.
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
K962673 · Princeton BioMeditech Corp. · Aug 1996
CEDIA DAU METHADONE ASSAY
K954227 · Microgenics Corp. · Nov 1995
AXSYM METHADONE
K953499 · Abbott Laboratories · Nov 1995
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
K944074 · Beckman Instruments, Inc. · Dec 1994
METHADONE ENZYME IMMUNOASSAY
K934667 · Diagnostic Reagents, Inc. · Jan 1994
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993