Cleared Special

K983703 - MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE

K983703 is an FDA 510(k) clearance for MODIFICATION TO ABUSCREEN ONLINE FOR ME..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DJR cleared through the Special 510(k) pathway after a 51-day FDA review.

K983703 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
51d
Days
Class 2
Risk

K983703 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 51 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K983703

510(k) Number K983703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date December 11, 1998
Days to Decision 51 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 87d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

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 62
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K983703.
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · Syva Co. · Jan 2000
ACCUSIGN MTD, BIOSIGN MTD
K991080 · Princeton BioMeditech Corp. · Apr 1999
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153
K982938 · Phamatech · Feb 1999
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
K981314 · Sun Biomedical Laboratories, Inc. · Sep 1998
CEDIA DAU EDDP ASSAY
K980746 · Boehringer Mannheim Corp. · May 1998
SYNCHRON SYSTEMS METHADONE REAGENT
K973069 · Beckman Instruments, Inc. · Sep 1997
K983703 · MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
Download PDF FDA Summary Roche Diagnostic Syst…