Cleared Traditional

K010015 - INSTANT-VIEW METHADONE URINE CASSETTE TEST

K010015 is the FDA 510(k) clearance for INSTANT-VIEW METHADONE URINE CASSETTE TEST by Alfa Scientific Designs, Inc.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K010015 · Alfa Scientific Designs, Inc. · Toxicology device
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May 2001
Decision
147d
Days
Class 2
Risk

K010015 is an FDA 510(k) clearance for the INSTANT-VIEW METHADONE URINE CASSETTE TEST. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 147 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 Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K010015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2001
Decision Date May 29, 2001
Days to Decision 147 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 87d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 47
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K010015.
METHADONE
K013001 · Abbott Laboratories · Mar 2002
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · ACON Laboratories, Inc. · Oct 2001
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
K010014 · Alfa Scientific Designs, Inc. · May 2001
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
K000466 · Dade Behring, Inc. · Apr 2000
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · Syva Co. · Jan 2000
ACCUSIGN MTD, BIOSIGN MTD
K991080 · Princeton BioMeditech Corp. · Apr 1999