Cleared Traditional

K864925 - EMDS TM PHENYTOIN (PTN) TESTPACK

K864925 is the FDA 510(k) clearance for EMDS TM PHENYTOIN (PTN) TESTPACK by Em Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DIP) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K864925 · Em Diagnostic Systems, Inc. · Toxicology device
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Jan 1987
Decision
22d
Days
Class 2
Risk

K864925 is an FDA 510(k) clearance for the EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 7, 1987 after a review of 22 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K864925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1986
Decision Date January 07, 1987
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
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 K864925.
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
K874856 · Syva Co. · Jan 1988
PHENYTOIN FPIA REAGENT SET
K870953 · Sigma Diagnostics, Inc. · Mar 1987
EASY-TEST PRIMIDONE ITEM NO. 67---/95
K864554 · Em Diagnostic Systems, Inc. · Jan 1987
PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS
K863403 · Technicon Instruments Corp. · Sep 1986
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
K862349 · Em Diagnostic Systems, Inc. · Jul 1986
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)
K860048 · Clinical Data, Inc. · Jan 1986