Cleared Traditional

K983174 - ONTRAK TESTSTIK FOR BARBITURATES

K983174 is the FDA 510(k) clearance for ONTRAK TESTSTIK FOR BARBITURATES by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K983174 · Roche Diagnostic Systems, Inc. · Toxicology device
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Nov 1998
Decision
69d
Days
Class 2
Risk

K983174 is an FDA 510(k) clearance for the ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K983174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1998
Decision Date November 18, 1998
Days to Decision 69 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 87d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 67
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K983174.
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · Roche Diagnostics Corp. · Jun 1999
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
K991079 · Princeton BioMeditech Corp. · Apr 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
K983702 · Roche Diagnostic Systems, Inc. · Feb 1999
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
K981687 · Phamatech · Jun 1998
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B
K974181 · Princeton BioMeditech Corp. · Dec 1997
CEDIA DAU BENZODIAZEPINE ASSAY
K962734 · Boehringer Mannheim Corp. · Dec 1996