Cleared Traditional

K092048 - ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP

K092048 is an FDA 510(k) clearance for ONE STEP EDDP (METHADONE METABOLITE) TE..., manufactured by Biosite Incorporated. The device is a Class 2 Chemistry device with product code DJR cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K092048 · Biosite Incorporated · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
286d
Days
Class 2
Risk

K092048 is an FDA 510(k) clearance for the ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on April 19, 2010 after a review of 286 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3620 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosite Incorporated devices

FDA 510(k) Submission Details - K092048

510(k) Number K092048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2009
Decision Date April 19, 2010
Days to Decision 286 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 88d · This submission: 286d
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 Chemistry 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 K092048.
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
K131232 · Guangzhou Wondfo Biotech Co., Ltd. · May 2013
RANDOX METHADONE ASSAY
K092272 · Randox Laboratories, Ltd. · Nov 2010
RANDOX METABOLITE (EDDP) ASSAY
K092258 · Randox Laboratories, Ltd. · Nov 2010
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
K081378 · Thermo Fisher Scientific · Jan 2009
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
K062637 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791 · Biosite Incorporated · Jun 2006