Cleared Traditional

K021505 - ONLINE DAT II METHADONE II

K021505 is the FDA 510(k) clearance for ONLINE DAT II METHADONE II by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K021505 · Roche Diagnostics Corp. · Toxicology device
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Jul 2002
Decision
68d
Days
Class 2
Risk

K021505 is an FDA 510(k) clearance for the ONLINE DAT II METHADONE II. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 16, 2002 after a review of 68 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K021505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date July 16, 2002
Days to Decision 68 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
19d faster than avg
Panel avg: 87d · This submission: 68d
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 38
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K021505.
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
K062637 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
RANDOX METHADONE ASSAY
K040570 · Randox Laboratories, Ltd. · May 2004
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · Microgenics Corp. · Aug 2003
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · Roche Diagnostics Corp. · Jul 2002
METHADONE
K013001 · Abbott Laboratories · Mar 2002
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · ACON Laboratories, Inc. · Oct 2001