Cleared Traditional

K950280 - TDX/TDXFLX FREE PHENYTOIN II

K950280 is an FDA 510(k) clearance for TDX/TDXFLX FREE PHENYTOIN II, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code MOJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K950280 · Abbott Laboratories · Toxicology device
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May 1995
Decision
98d
Days
Class 2
Risk

K950280 is an FDA 510(k) clearance for the TDX(R)/TDXFLX(R) FREE PHENYTOIN II. Classified as Fluorescence Polarization Immunoassay, Diphenylhydantoin (free) (product code MOJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 98 days - within the typical 510(k) review window.

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 Abbott Laboratories devices

FDA 510(k) Submission Details - K950280

510(k) Number K950280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1995
Decision Date May 02, 1995
Days to Decision 98 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
11d slower than avg
Panel avg: 87d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOJ Device Classification - Class 2, Special Controls

Product Code MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (free)
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.