Cleared Traditional

K810602 - EMIT-ST SERUM BARBITURATE ASSAY

K810602 is the FDA 510(k) clearance for EMIT-ST SERUM BARBITURATE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K810602 · Syva Co. · Toxicology device
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Apr 1981
Decision
28d
Days
Class 2
Risk

K810602 is an FDA 510(k) clearance for the EMIT-ST SERUM 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 April 3, 1981 after a review of 28 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 K810602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1981
Decision Date April 03, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 87d · This submission: 28d
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 K810602.
ACA BARBITURATES SCREEN ANALY TEST PACK
K842783 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984
EMIT ST SERUM BARBITURATE ASSAY
K840194 · Syva Co. · Mar 1984
MODIF. OF EMIT URINE BARBITURATE
K833577 · Syva Co. · Jan 1984
EMIT-STM BARBITURATE ASSAY
K802617 · Syva Co. · Oct 1980
EMIT-BARBITURATE ASSAY
K792114 · Syva Co. · Dec 1979