Cleared Traditional

K942404 - CEDIA DAU BARBITURATE ASSAY

K942404 is the FDA 510(k) clearance for CEDIA DAU BARBITURATE ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K942404 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
129d
Days
Class 2
Risk

K942404 is an FDA 510(k) clearance for the CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on July 28, 1994 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 K942404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date July 28, 1994
Days to Decision 129 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 87d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 67
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K942404.
CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST
K944075 · Beckman Instruments, Inc. · Dec 1994
CEDIA DAU BARBITURATE ASSAY
K945344 · Microgenics Corp. · Dec 1994
CEDIA DAU BARBITURATE ASSAY
K942436 · Microgenics Corp. · Aug 1994
CEDIA DAU BARBITURATE ASSAY
K936030 · Microgenics Corp. · Mar 1994
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · Syva Co. · Jun 1993
EMIT(R) II BARBITURATE ASSAY
K926068 · Syva Co. · Jan 1993