Cleared Traditional

K904815 - QMS TM- PHENYTOIN

K904815 is the FDA 510(k) clearance for QMS TM- PHENYTOIN by Seradyn, Inc.. It is a Class 2 Chemistry device (product code DIP) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K904815 · Seradyn, Inc. · Chemistry device
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Nov 1990
Decision
13d
Days
Class 2
Risk

K904815 is an FDA 510(k) clearance for the QMS TM- PHENYTOIN. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 6, 1990 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3350 - the FDA in vitro diagnostics and chemistry 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 Seradyn, Inc. devices

Submission Details

510(k) Number K904815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1990
Decision Date November 06, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DIP Enzyme Immunoassay, Diphenylhydantoin

All 37
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K904815.
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
K913429 · Syva Co. · Aug 1991
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
K911056 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1991
CEDIA PHENYTOIN ASSAY
K905689 · Microgenics Corp. · Jan 1991
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