Cleared Traditional

K873538 - ACA URINE BENZODIAZEPINES (UBENZ) SCREE...

K873538 is the FDA 510(k) clearance for ACA URINE BENZODIAZEPINES (UBENZ) SCREE... by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K873538 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Oct 1987
Decision
31d
Days
Class 2
Risk

K873538 is an FDA 510(k) clearance for the ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on October 2, 1987 after a review of 31 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K873538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date October 02, 1987
Days to Decision 31 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
56d faster than avg
Panel avg: 87d · This submission: 31d
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 K873538.
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
K874376 · Syva Co. · Nov 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489 · Abbott Laboratories · Nov 1987
REVISED LABELING FOR BENZODIAZEPINE TEST KIT
K874265 · Roche Diagnostic Systems, Inc. · Nov 1987
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
K870994 · Roche Diagnostic Systems, Inc. · Mar 1987
BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K863877 · General Diagnostics · Mar 1987
TDX BENZODIAZEPINES
K862250 · Abbott Laboratories · Jul 1986