Cleared Traditional

K013001 - METHADONE

K013001 is an FDA 510(k) clearance for METHADONE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K013001 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
195d
Days
Class 2
Risk

K013001 is an FDA 510(k) clearance for the METHADONE. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 20, 2002 after a review of 195 days - an extended review 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K013001

510(k) Number K013001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date March 20, 2002
Days to Decision 195 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
108d slower than avg
Panel avg: 87d · This submission: 195d
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 51
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K013001.
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
'RAPIDONE'-METHADONE TEST
K012164 · American Bio Medica Corp. · Nov 2001
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