Cleared Traditional

CEDIA DAU BENZODIAZEPINE ASSAY (K962734) - FDA 510(k) Clearance

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

K962734 · Boehringer Mannheim Corp. · Toxicology device
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Dec 1996
Decision
148d
Days
Class 2
Risk

K962734 is an FDA 510(k) clearance for the CEDIA DAU BENZODIAZEPINE ASSAY. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on December 10, 1996 after a review of 148 days - within the typical 510(k) review window.

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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K962734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date December 10, 1996
Days to Decision 148 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 87d · This submission: 148d
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 49
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K962734.
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · Roche Diagnostics Corp. · Jun 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
K983702 · Roche Diagnostic Systems, Inc. · Feb 1999
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · Roche Diagnostic Systems, Inc. · Nov 1998
AXSYM BENZODIAZEPINES
K951286 · Abbott Laboratories · May 1995
AXSYM CANNABINOIDS
K951288 · Abbott Laboratories · May 1995
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995