Cleared Traditional

K842675 - EMIT D.A.U. BARBITURATE ASSAY

K842675 is the FDA 510(k) clearance for EMIT D.A.U. BARBITURATE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K842675 · Syva Co. · Toxicology device
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Sep 1984
Decision
78d
Days
Class 2
Risk

K842675 is an FDA 510(k) clearance for the EMIT D.A.U. BARBITURATE ASSAY. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Syva Co. devices

Submission Details

510(k) Number K842675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date September 26, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 87d · This submission: 78d
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 K842675.
QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
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K843418 · Syva Co. · Sep 1984
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K842783 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984
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K840194 · Syva Co. · Mar 1984