Cleared Traditional

PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (K943313) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943313 · Sigma Diagnostics, Inc. · Toxicology device
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Oct 1994
Decision
108d
Days
Class 2
Risk

K943313 is an FDA 510(k) clearance for the PHENYTOIN FPIA REAGENT SET AND CALIBRATORS. Classified as Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (product code LGR), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 27, 1994 after a review of 108 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K943313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1994
Decision Date October 27, 1994
Days to Decision 108 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 87d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)
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 - LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

All 14
Devices cleared under the same product code (LGR) and FDA review panel - the closest regulatory comparables to K943313.
AXSYM PHENYTOIN II
K953840 · Abbott Laboratories · Sep 1995
TDX(R)/TDXFLX(R) PHENYTOIN II
K946328 · Abbott Laboratories · Mar 1995
AXSYM PHENYTOIN ASSAY
K935375 · Abbott Laboratories · Jun 1994
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
K936131 · Roche Diagnostic Systems, Inc. · Mar 1994
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
K843824 · Roche Diagnostic Systems, Inc. · Feb 1985
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
K844171 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984