Cleared Traditional

K874856 - EMIT CONVENIENCE PACK: PHENYTOIN ASSAY

K874856 is the FDA 510(k) clearance for EMIT CONVENIENCE PACK: PHENYTOIN ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DIP) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K874856 · Syva Co. · Toxicology device
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Jan 1988
Decision
41d
Days
Class 2
Risk

K874856 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK: PHENYTOIN ASSAY. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), 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 41 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - 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 K874856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1987
Decision Date January 05, 1988
Days to Decision 41 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
46d faster than avg
Panel avg: 87d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 - DIP Enzyme Immunoassay, Diphenylhydantoin

All 36
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K874856.
IL PHENYTOIN ASSAY SYSTEM
K902952 · Instrumentation Laboratory CO · Aug 1990
EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT
K901080 · Immunotech Corp. · May 1990
VISION PHENYTOIN
K896074 · Abbott Laboratories · Nov 1989
PHENYTOIN FPIA REAGENT SET
K870953 · Sigma Diagnostics, Inc. · Mar 1987
EASY-TEST PRIMIDONE ITEM NO. 67---/95
K864554 · Em Diagnostic Systems, Inc. · Jan 1987
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
K864925 · Em Diagnostic Systems, Inc. · Jan 1987