Cleared Traditional

K930844 - ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE

K930844 is an FDA 510(k) clearance for ROCHE ABUSCREEN ONTRAK POS. REF. CONTRO..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K930844 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
343d
Days
Class 1
Risk

K930844 is an FDA 510(k) clearance for the ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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. Elevated predicate reliance profile. 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 - K930844

510(k) Number K930844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1993
Decision Date January 27, 1994
Days to Decision 343 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
256d slower than avg
Panel avg: 87d · This submission: 343d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LAS Drug Specific Control Materials

All 69
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K930844.
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · Beckman Instruments, Inc. · Apr 1997
ROCHE-TDM ONLEIN(TM) CONTROLS
K946119 · Roche Diagnostic Systems, Inc. · Feb 1995
MICROGENICS THC CONTROL SETS
K943048 · Microgenics Corp. · Aug 1994
DUPONT ACA URINE METHADONE CONTROL
K934145 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE
K933557 · Consolidated Technologies, Inc. · Sep 1993
CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL
K932662 · More Diagnostics · Jul 1993