Cleared Traditional

K023252 - RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020

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

K023252 · Icn Biomedicals, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K023252

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.

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 59
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K023252.
VISUALINE METHADONE DIPSTRIPTEST
K023856 · Sun Biomedical Laboratories, Inc. · Aug 2003
'RAPIDTEC'-5M-MULTIPLE DIP TEST
K023869 · American Bio Medica Corp. · Apr 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