Cleared Traditional

K874702 - REVISED LABELING FOR SYVA BARBITURATE A...

K874702 is the FDA 510(k) clearance for REVISED LABELING FOR SYVA BARBITURATE A... by Syva Co.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K874702 · Syva Co. · Toxicology device
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Jan 1988
Decision
50d
Days
Class 2
Risk

K874702 is an FDA 510(k) clearance for the REVISED LABELING FOR SYVA BARBITURATE ASSAYS. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 50 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 K874702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1987
Decision Date January 05, 1988
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
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 K874702.
BARBITURATE ENZYME IMMUNOASSAY KIT
K882663 · General Diagnostics · Sep 1988
EMIT HVA BARBITURATE ASSAY
K882611 · Syva Co. · Aug 1988
REVISED LABELING FOR ADX BARBITURATES
K880012 · Abbott Laboratories · Mar 1988
REVISED LABELING FOR TDX BARBITURATES
K874483 · Abbott Laboratories · Nov 1987
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
K874210 · Roche Diagnostic Systems, Inc. · Nov 1987
REVISED LABELING FOR BARBITURATE TEST KIT
K874266 · Roche Diagnostic Systems, Inc. · Nov 1987