Cleared Traditional

TDX BENZODIAZEPINES (K862250) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862250 · Abbott Laboratories · Toxicology device
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Jul 1986
Decision
29d
Days
Class 2
Risk

K862250 is an FDA 510(k) clearance for the TDX 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 July 11, 1986 after a review of 29 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 Abbott Laboratories devices

Submission Details

510(k) Number K862250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1986
Decision Date July 11, 1986
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
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 51
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K862250.
REVISED LABELING FOR BENZODIAZEPINE TEST KIT
K874265 · Roche Diagnostic Systems, Inc. · Nov 1987
ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD
K873538 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1987
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
K870994 · Roche Diagnostic Systems, Inc. · Mar 1987
EMIT 700 BENZODIAZEPINE ASSAY
K851568 · Syva Co. · May 1985
EMIT D.A.U. BENZODIAZEPINE ASSAY
K842815 · Syva Co. · Sep 1984
ACA BENZODIAZEPINES SCREEN TEST PK
K842387 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984