Cleared Traditional

K930928 - ROCHE ABUSCREEN ONLINE FOR METHADONE

K930928 is an FDA 510(k) clearance for ROCHE ABUSCREEN ONLINE FOR METHADONE, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K930928 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
213d
Days
Class 2
Risk

K930928 is an FDA 510(k) clearance for the ROCHE ABUSCREEN ONLINE FOR METHADONE. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on September 24, 1993 after a review of 213 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K930928

510(k) Number K930928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date September 24, 1993
Days to Decision 213 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 87d · This submission: 213d
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 54
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K930928.
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
K944074 · Beckman Instruments, Inc. · Dec 1994
METHADONE ENZYME IMMUNOASSAY
K934667 · Diagnostic Reagents, Inc. · Jan 1994
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
METHADONE METABOLITE EIA ASSAY
K931780 · Diagnostic Reagents, Inc. · Aug 1993
IL TEST METHADONE
K920858 · Instrumentation Laboratory CO · Apr 1992
SYVA EMIT II METHADONE ASSAY
K920751 · Syva Co. · Mar 1992