Cleared Traditional

K940159 - CEDIA DAU BENZODIAZEPINE ASSAY

K940159 is the FDA 510(k) clearance for CEDIA DAU BENZODIAZEPINE ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K940159 · Microgenics Corp. · Toxicology device
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May 1994
Decision
135d
Days
Class 2
Risk

K940159 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 Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 135 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 Microgenics Corp. devices

Submission Details

510(k) Number K940159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1994
Decision Date May 27, 1994
Days to Decision 135 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
48d slower than avg
Panel avg: 87d · This submission: 135d
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 K940159.
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS
K944076 · Beckman Instruments, Inc. · Nov 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K942795 · Microgenics Corp. · Aug 1994
BENZODIAZEPINE ENZYME IMMUNOASSAY
K930529 · Diagnostic Reagents, Inc. · Aug 1993
EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
K931536 · Syva Co. · May 1993
EMIT(R) II BENZODIAZEPINE ASSAY
K926067 · Syva Co. · Jan 1993