← Product Code [DLJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ) · K970509 # INNOFLOUR CALIBRATOR REAGENT SET (K970509) _Oxis Intl., Inc. · DLJ · May 12, 1997 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K970509 ## Device Facts - **Applicant:** Oxis Intl., Inc. - **Product Code:** [DLJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ.md) - **Decision Date:** May 12, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3200 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 A3 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K970509](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K970509) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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