INNOFLOUR CALIBRATOR REAGENT SET

K970509 · Oxis Intl., Inc. · DLJ · May 12, 1997 · Clinical Toxicology

Device Facts

• Record ID: K970509
• Device Name: INNOFLOUR CALIBRATOR REAGENT SET
• Applicant: Oxis Intl., Inc.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: May 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

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; operated by laboratory personnel; provides quantitative results for therapeutic drug monitoring; assists clinicians in managing topiramate dosage; benefits patients by ensuring therapeutic levels and minimizing toxicity.

Clinical Evidence

Bench testing; comparison of 117 patient samples using INNOFLUOR™ Topiramate Assay System on Abbott TDx® analyzer versus Gas Chromatography (GC). Linear regression analysis: y = 0.985x - 0.147; correlation coefficient r = 0.9934.

Technological Characteristics

Fluorescence polarization immunoassay (FPIA) technology; reagents, calibrators, and controls for use on Abbott TDx®/TDxFLx® analyzers; quantitative measurement of topiramate in serum/plasma.

Indications for Use

Indicated for quantitative determination of total topiramate in serum or heparinized plasma for therapeutic drug monitoring in patients receiving topiramate therapy.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• INNOFLUOR™ Phenobarbital Assay System (INNOFLUOR™ Phenobarbital Reagent Set and INNOFLUOR™ Phenobarbital Calibrator Set)
• Abbott Phenobarbital II Assay

Reference Devices

• Topiramate Gas Chromatography

Submission Summary (Full Text)

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K970509 MAY 12 1997

# 510(k) SUMMARY
## INNOFLUOR™ TOPIRAMATE CALIBRATOR 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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