Cleared Traditional

K915755 - BIOTRACK PHENYTOIN TEST CARTRIDGE

K915755 is the FDA 510(k) clearance for BIOTRACK PHENYTOIN TEST CARTRIDGE by Biotrack, Inc.. It is a Class 2 Toxicology device (product code DIP) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K915755 · Biotrack, Inc. · Toxicology device
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Jul 1992
Decision
213d
Days
Class 2
Risk

K915755 is an FDA 510(k) clearance for the BIOTRACK PHENYTOIN TEST CARTRIDGE. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 213 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotrack, Inc. devices

Submission Details

510(k) Number K915755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date July 23, 1992
Days to Decision 213 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 87d · This submission: 213d
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 37
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K915755.
PHENYTION EIA TEST
K945725 · Diagnostic Reagents, Inc. · Feb 1995
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
K941142 · Eastman Kodak Company · Jun 1994
PARAMAX(R) PHENYTOIN REAGENT
K932686 · Baxter Diagnostics, Inc. · Nov 1993
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