Cleared Traditional

K860048 - DETERMINATION OF PHENYTOIN (DIPHENYLHYD...

K860048 is the FDA 510(k) clearance for DETERMINATION OF PHENYTOIN (DIPHENYLHYD... by Clinical Data, Inc.. It is a Class 2 Toxicology device (product code DIP) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K860048 · Clinical Data, Inc. · Toxicology device
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Jan 1986
Decision
16d
Days
Class 2
Risk

K860048 is an FDA 510(k) clearance for the DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN). Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 16 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K860048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date January 22, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
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 34
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K860048.
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
K864925 · 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
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY
K850712 · Syva Co. · Mar 1985
SERALYZER ARIS PHENYTOIN REAGENT STRIPS
K842092 · Miles Laboratories, Inc. · Mar 1985
EMIT PHENYTOIN ASSAY
K844991 · Syva Co. · Jan 1985