Cleared Traditional

K023252 - RAPID METHADONE TEST STRIP

K023252 is the FDA 510(k) clearance for RAPID METHADONE TEST STRIP by Icn Biomedicals, Inc.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K023252 · Icn Biomedicals, Inc. · Toxicology device
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Nov 2002
Decision
53d
Days
Class 2
Risk

K023252 is an FDA 510(k) clearance for the RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Icn Biomedicals, Inc. (Burlingame, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icn Biomedicals, Inc. devices

Submission Details

510(k) Number K023252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date November 22, 2002
Days to Decision 53 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 87d · This submission: 53d
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 48
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K023252.
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
K031797 · Lin-Zhi International, Inc. · Oct 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · Microgenics Corp. · Aug 2003
METHADONE ENZYME IMMUNOASSAY
K023317 · Lin-Zhi International, Inc. · Dec 2002
ONLINE DAT II METHADONE II
K021505 · Roche Diagnostics Corp. · Jul 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · Roche Diagnostics Corp. · Jul 2002
METHADONE
K013001 · Abbott Laboratories · Mar 2002