Cleared Traditional

K890691 - ADX TM BENZODIAZEPINES

K890691 is an FDA 510(k) clearance for ADX TM BENZODIAZEPINES, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K890691 · Abbott Laboratories · Toxicology device
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Aug 1989
Decision
192d
Days
Class 2
Risk

K890691 is an FDA 510(k) clearance for the ADX TM BENZODIAZEPINES. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 25, 1989 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K890691

510(k) Number K890691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1989
Decision Date August 25, 1989
Days to Decision 192 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
105d slower than avg
Panel avg: 87d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

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 75
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K890691.
EMIT II BENZODIAZEPINE ASSAY
K910376 · Syva Co. · Feb 1991
MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K896780 · Immunotech Corp. · Mar 1990
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
K896744 · Bio-Rad · Feb 1990
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697 · Roche Diagnostic Systems, Inc. · Mar 1989
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K890001 · Diagnostic Products Corp. · Jan 1989
TDX BENZODIAZEPINES SERUM
K883730 · Abbott Laboratories · Nov 1988