Cleared Traditional

K943313 - PHENYTOIN FPIA REAGENT SET AND CALIBRATORS

K943313 is an FDA 510(k) clearance for PHENYTOIN FPIA REAGENT SET AND CALIBRATORS, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code LGR cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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

FDA 510(k) Submission Details - K943313

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
Combination Product No
PCCP Authorized No
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.

LGR Device Classification - Class 2, Special Controls

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 13
Devices cleared under the same product code (LGR) and FDA review panel - the closest regulatory comparables to K943313.
INNOFLUOR PHENYTOIN ASSAY SYSTEM
K955562 · Oxis Intl., Inc. · Jan 1996
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
OPUS PHENYTOIN TEST SYSTEM
K896868 · Pb Diagnostic Systems, Inc. · Jan 1990