Cleared Traditional

K930844 - ROCHE ABUSCREEN ONTRAK POS. REF. CONTRO...

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

K930844 · Roche Diagnostic Systems, Inc. · Toxicology device
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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

Submission Details

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.

Device Classification

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 53
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
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
K921939 · Heraeus Kulzer, Inc. · Jul 1992
CANNABINOID URINE CONTROLS
K921141 · Diagnostic Reagents, Inc. · Apr 1992