Cleared Traditional

K842586 - PHENYTOIN KIT FLUORESCENCE POLARIZATION

K842586 is an FDA 510(k) clearance for PHENYTOIN KIT FLUORESCENCE POLARIZATION, manufactured by Windsor Laboratories, Inc.. The device is a Class 2 Immunology device with product code LGR cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K842586 · Windsor Laboratories, Inc. · Immunology device
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Sep 1984
Decision
85d
Days
Class 2
Risk

K842586 is an FDA 510(k) clearance for the PHENYTOIN KIT FLUORESCENCE POLARIZATION. Classified as Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (product code LGR), Class II - Special Controls.

Submitted by Windsor Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3350 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Windsor Laboratories, Inc. devices

FDA 510(k) Submission Details - K842586

510(k) Number K842586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date September 26, 1984
Days to Decision 85 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 105d · This submission: 85d
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 Immunology 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 K842586.
IMMPULSE PHENYTOIN ASSAY REAGENT
K862554 · Sclavo, Inc. · Jul 1986
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