Cleared Traditional

K863625 - PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT

K863625 is an FDA 510(k) clearance for PHENOBARBITAL-FPIA FLUORES. POLAR. IMMU..., manufactured by Windsor Laboratories, Inc.. The device is a Class 2 Toxicology device with product code LGQ cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K863625 · Windsor Laboratories, Inc. · Toxicology device
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Nov 1986
Decision
54d
Days
Class 2
Risk

K863625 is an FDA 510(k) clearance for the PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT. Classified as Fluorescence Polarization Immunoassay, Phenobarbital (product code LGQ), Class II - Special Controls.

Submitted by Windsor Laboratories, Inc. (Garland, US). The FDA issued a Cleared decision on November 10, 1986 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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.

FDA 510(k) Submission Details - K863625

510(k) Number K863625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1986
Decision Date November 10, 1986
Days to Decision 54 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
33d faster than avg
Panel avg: 87d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGQ Device Classification - Class 2, Special Controls

Product Code LGQ Fluorescence Polarization Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 - LGQ Fluorescence Polarization Immunoassay, Phenobarbital

All 11
Devices cleared under the same product code (LGQ) and FDA review panel - the closest regulatory comparables to K863625.
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704 · Innotron of Oregon, Inc. · Apr 1990
FPR PHENOBARBITAL KIT
K894525 · Colony Laboratories, Inc. · Aug 1989
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397 · Roche Diagnostic Systems, Inc. · Jul 1987
IMMPULSE PHENOBARBITAL ASSAY REAGENTS
K862528 · Sclavo, Inc. · Jul 1986
TDX BARBITURATES
K854044 · Abbott Laboratories · Oct 1985
COBAS REAGENTS PHENOBARBITAL & PHENOBAR
K843825 · Roche Diagnostic Systems, Inc. · Feb 1985
K863625 · PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT
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