Cleared Traditional

K932686 - PARAMAX(R) PHENYTOIN REAGENT

K932686 is an FDA 510(k) clearance for PARAMAX PHENYTOIN REAGENT, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DIP cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K932686 · Baxter Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
176d
Days
Class 2
Risk

K932686 is an FDA 510(k) clearance for the PARAMAX(R) PHENYTOIN REAGENT. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Irvine, US). The FDA issued a Cleared decision on November 26, 1993 after a review of 176 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 Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K932686

510(k) Number K932686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1993
Decision Date November 26, 1993
Days to Decision 176 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 87d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIP Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K932686.
PHENYTION EIA TEST
K945725 · Diagnostic Reagents, Inc. · Feb 1995
ACE(TM) CEDIA(R) PHENYTOIN ASSAY
K944085 · Schiapparelli Biosystems, Inc. · Dec 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
K941142 · Eastman Kodak Company · Jun 1994
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