Cleared Traditional

K932686 - PARAMAX PHENYTOIN REAGENT

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

K932686 · Baxter Diagnostics, Inc. · Toxicology device
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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

Submission Details

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.

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
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