Cleared Traditional

K012595 - ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE

K012595 is an FDA 510(k) clearance for ACON MTD ONE STEP METHADONE TEST STRIP ..., manufactured by ACON Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K012595 · ACON Laboratories, Inc. · Toxicology device
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Oct 2001
Decision
66d
Days
Class 2
Risk

K012595 is an FDA 510(k) clearance for the ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on October 15, 2001 after a review of 66 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 ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K012595

510(k) Number K012595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2001
Decision Date October 15, 2001
Days to Decision 66 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
21d faster than avg
Panel avg: 87d · This submission: 66d
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 57
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K012595.
COBAS INTEGRA ONLINE DAT II METHADONE II
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METHADONE
K013001 · Abbott Laboratories · Mar 2002
'RAPIDONE'-METHADONE TEST
K012164 · American Bio Medica Corp. · Nov 2001
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
K010014 · Alfa Scientific Designs, Inc. · May 2001
INSTANT-VIEW METHADONE URINE CASSETTE TEST
K010015 · Alfa Scientific Designs, Inc. · May 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
K010962 · Syva Co., Dade Behring, Inc. · Apr 2001