Cleared Traditional

K891697 - ABUSCREEN FP BENZODIAZEPHINE REAGENT

K891697 is the FDA 510(k) clearance for ABUSCREEN FP BENZODIAZEPHINE REAGENT by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K891697 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1989
Decision
9d
Days
Class 2
Risk

K891697 is an FDA 510(k) clearance for the ABUSCREEN FP BENZODIAZEPHINE REAGENT. 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 March 31, 1989 after a review of 9 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 K891697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1989
Decision Date March 31, 1989
Days to Decision 9 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
78d faster than avg
Panel avg: 87d · This submission: 9d
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 K891697.
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
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K890001 · Diagnostic Products Corp. · Jan 1989
TDX BENZODIAZEPINES SERUM
K883730 · Abbott Laboratories · Nov 1988
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
K883459 · Diagnostic Products Corp. · Sep 1988