Cleared Traditional

K862554 - IMMPULSE PHENYTOIN ASSAY REAGENT

K862554 is an FDA 510(k) clearance for IMMPULSE PHENYTOIN ASSAY REAGENT, manufactured by Sclavo, Inc.. The device is a Class 2 Toxicology device with product code LGR cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K862554 · Sclavo, Inc. · Toxicology device
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Jul 1986
Decision
13d
Days
Class 2
Risk

K862554 is an FDA 510(k) clearance for the IMMPULSE PHENYTOIN ASSAY REAGENT. Classified as Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (product code LGR), Class II - Special Controls.

Submitted by Sclavo, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 16, 1986 after a review of 13 days - a notably fast clearance 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: 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 Sclavo, Inc. devices

FDA 510(k) Submission Details - K862554

510(k) Number K862554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date July 16, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 87d · This submission: 13d
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 K862554.
OPUS PHENYTOIN TEST SYSTEM
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INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
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INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
K872563 · Innotron of Oregon, Inc. · Aug 1987
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
PHENYTOIN KIT FLUORESCENCE POLARIZATION
K842586 · Windsor Laboratories, Inc. · Sep 1984