Cleared Traditional

K863877 - BENZODIAZEPINE ENZYME IMMUNOASSAY KIT

K863877 is the FDA 510(k) clearance for BENZODIAZEPINE ENZYME IMMUNOASSAY KIT by General Diagnostics. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K863877 · General Diagnostics · Toxicology device
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Mar 1987
Decision
157d
Days
Class 2
Risk

K863877 is an FDA 510(k) clearance for the BENZODIAZEPINE ENZYME IMMUNOASSAY KIT. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by General Diagnostics (Great Neck, US). The FDA issued a Cleared decision on March 12, 1987 after a review of 157 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.

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Submission Details

510(k) Number K863877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1986
Decision Date March 12, 1987
Days to Decision 157 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
70d slower than avg
Panel avg: 87d · This submission: 157d
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 69
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K863877.
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
TDX BENZODIAZEPINES
K862250 · Abbott Laboratories · Jul 1986
EMIT 700 BENZODIAZEPINE ASSAY
K851568 · Syva Co. · May 1985
EMIT D.A.U. BENZODIAZEPINE ASSAY
K842815 · Syva Co. · Sep 1984