K970517 · Oxis Intl., Inc. · LAS · May 12, 1997 · Clinical Toxicology
Device Facts
Record ID
K970517
Device Name
INNOFLUOR TOPIRAMATE CONTROL SET
Applicant
Oxis Intl., Inc.
Product Code
LAS · Clinical Toxicology
Decision Date
May 12, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.3280
Device Class
Class 1
Indications for Use
The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plasma for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.
Device Story
Fluorescence polarization immunoassay (FPIA) system; measures total topiramate concentration in serum or heparinized plasma. Used on Abbott TDx® or TDxFLx® analyzers. Clinical laboratory setting; operated by laboratory technicians. Input: patient serum/plasma samples. Process: competitive binding immunoassay principle. Output: quantitative topiramate concentration. Assists clinicians in therapeutic drug monitoring to optimize patient dosing and safety.
Clinical Evidence
Bench testing only. Comparison study of 117 patient samples using INNOFLUOR™ Topiramate Assay System versus Gas Chromatography (GC). Linear regression analysis yielded equation: y = 0.985x - 0.147; correlation coefficient (r) = 0.9934.
Technological Characteristics
Fluorescence polarization immunoassay (FPIA) technology. Designed for use on Abbott TDx®/TDxFLx® automated analyzers. Reagent, calibrator, and control sets provided. Analyte: Topiramate.
Indications for Use
Indicated for therapeutic drug monitoring of total topiramate levels in serum or heparinized plasma for patients receiving topiramate therapy.
Regulatory Classification
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
Predicate Devices
INNOFLUOR™ Phenobarbital Assay System
Abbott Phenobarbital II Assay
Reference Devices
Topiramate Gas Chromatography
Submission Summary (Full Text)
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K970517
MAY 12 1997
# 510(k) SUMMARY
## INNOFLUOR™ TOPIRAMATE CONTROL SET
**Trade Name:** INNOFLUOR™ Topiramate Assay System, which consists of three products that are packaged and sold separately: the INNOFLUOR™ Topiramate Reagent Set, the INNOFLUOR™ Topiramate Calibrator Set and the INNOFLUOR™ Topiramate Control Set.
**Common or Usual Name:** Topiramate Fluorescence Polarization Immunoassay
**Classification Name:** Fluorescence Polarization Immunoassay, Topiramate
The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plasma for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.
Substantial equivalence has been demonstrated between the INNOFLUOR™ Topiramate Assay System, the INNOFLUOR™ Phenobarbital Assay System (INNOFLUOR™ Phenobarbital Reagent Set and INNOFLUOR™ Phenobarbital Calibrator Set), the Abbott Phenobarbital II Assay and Topiramate Gas Chromatography.
The technological characteristics, performance and intended use of the INNOFLUOR™ Topiramate Assay System are substantially equivalent to the INNOFLUOR™ Phenobarbital Assay System and the Abbott Phenobarbital II Assay with the exception of the specific anticonvulsant tested for by each method.
Topiramate concentrations measured by the INNOFLUOR™ Topiramate Assay System (INNOFLUOR™), on the Abbott TDx® analyzer, were compared with those measured by Topiramate Gas Chromatography (GC) on 117 patient samples from patients receiving topiramate therapy. Comparison of the patient sample results by linear regression analysis resulted in the regression equation: $$(\text{INNOFLUOR}^{\text{TM}}) = 0.985 \times (\text{GC}) - 0.147$$, with a correlation coefficient of 0.9934, demonstrating equivalency of results.
**Contact Person:** Lynda M. Taylor
Vice President Quality Assurance and Regulatory Affairs
**Date Prepared:** 01/29/97
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