Cleared Traditional

K910590 - ABUSCREEN ONTRAK FOR BENZODIAZEPINE

K910590 is the FDA 510(k) clearance for ABUSCREEN ONTRAK FOR BENZODIAZEPINE by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K910590 · Roche Diagnostic Systems, Inc. · Toxicology device
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Apr 1991
Decision
52d
Days
Class 2
Risk

K910590 is an FDA 510(k) clearance for the ABUSCREEN ONTRAK FOR BENZODIAZEPINE. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on April 5, 1991 after a review of 52 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 K910590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date April 05, 1991
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
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 K910590.
EMIT D.A.U BENZODIAZEPINE ASSAY
K915501 · Syva Co. · Feb 1992
IL TEST(TM) BENZODIAZEPINE
K914815 · Instrumentation Laboratory CO · Jan 1992
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
K914509 · Roche Diagnostic Systems, Inc. · Nov 1991
EMIT II BENZODIAZEPINE ASSAY
K910376 · Syva Co. · Feb 1991
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
K896744 · Bio-Rad · Feb 1990
ADX TM BENZODIAZEPINES
K890691 · Abbott Laboratories · Aug 1989