Cleared Traditional

K994380 - CEDIA DAU AMPHASSURE ASSAY

K994380 is the FDA 510(k) clearance for CEDIA DAU AMPHASSURE ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K994380 · Microgenics Corp. · Toxicology device
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May 2000
Decision
127d
Days
Class 2
Risk

K994380 is an FDA 510(k) clearance for the CEDIA DAU AMPHASSURE ASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on May 2, 2000 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 K994380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1999
Decision Date May 02, 2000
Days to Decision 127 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
40d slower than avg
Panel avg: 87d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K994380.
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