Cleared Traditional

K962734 - CEDIA DAU BENZODIAZEPINE ASSAY

K962734 is an FDA 510(k) clearance for CEDIA DAU BENZODIAZEPINE ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 148-day FDA review.

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

FDA 510(k) Submission Details - K962734

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.

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 K962734.
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
K982831 · OraSure Technologies, Inc. · Nov 1998
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K981687 · Phamatech · Jun 1998
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B
K974181 · Princeton BioMeditech Corp. · Dec 1997
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
K962672 · Princeton BioMeditech Corp. · Aug 1996
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP
K961325 · Princeton BioMeditech Corp. · Jun 1996
BENZODIAZEPINE SERUM TOX EIA TEST
K960708 · Diagnostic Reagents, Inc. · May 1996