Cleared Traditional

K936030 - CEDIA DAU BARBITURATE ASSAY

K936030 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 95-day FDA review.

K936030 · Microgenics Corp. · Toxicology device
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Mar 1994
Decision
95d
Days
Class 2
Risk

K936030 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 March 22, 1994 after a review of 95 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 - K936030

510(k) Number K936030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1993
Decision Date March 22, 1994
Days to Decision 95 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
8d slower than avg
Panel avg: 87d · This submission: 95d
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 K936030.
CEDIA DAU BARBITURATE ASSAY
K942436 · Microgenics Corp. · Aug 1994
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404 · Microgenics Corp. · Jul 1994
ACE CLINICAL CHEMISTRY SYSTEM
K941489 · Schiapparelli Biosystems, Inc. · Jul 1994
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · Syva Co. · Jun 1993
EMIT(R) II BARBITURATE ASSAY
K926068 · Syva Co. · Jan 1993
BARBITURATE EIA TEST
K925491 · Diagnostic Reagents, Inc. · Dec 1992