Cleared Traditional

K942436 - CEDIA DAU BARBITURATE ASSAY

K942436 is an FDA 510(k) clearance for CEDIA DAU BARBITURATE ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K942436 · Microgenics Corp. · Toxicology device
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Aug 1994
Decision
124d
Days
Class 2
Risk

K942436 is an FDA 510(k) clearance for the CEDIA DAU BARBITURATE ASSAY. 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 August 30, 1994 after a review of 124 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

FDA 510(k) Submission Details - K942436

510(k) Number K942436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date August 30, 1994
Days to Decision 124 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
37d slower than avg
Panel avg: 87d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K942436.
EMIT IIC BARBITURATE ASSAY
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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(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404 · Microgenics Corp. · Jul 1994
ACE CLINICAL CHEMISTRY SYSTEM
K941489 · Schiapparelli Biosystems, Inc. · Jul 1994
CEDIA DAU BARBITURATE ASSAY
K936030 · Microgenics Corp. · Mar 1994