(90 days)
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No
The summary describes a fluorescence polarization immunoassay for therapeutic drug monitoring, a standard laboratory technique. There is no mention of AI or ML in the intended use, device description, or performance studies. The comparison study uses linear regression, a statistical method, not AI/ML.
No
Explanation: This device is an assay system used for therapeutic drug monitoring, meaning it measures drug levels in the blood. It does not directly treat a medical condition or patient.
Yes
The device is described as an "immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plasma for therapeutic drug monitoring," which involves measuring a substance in bodily fluid to aid in patient management, a core function of a diagnostic device.
No
The device is a fluorescence polarization immunoassay system, which inherently involves chemical reagents and hardware (for use on the Abbott TDxf or TDxFLX® analyzer) to perform the assay. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of total topiramate in serum or heparinized plasma". This involves testing biological samples in vitro (outside the body).
- Therapeutic Drug Monitoring: The purpose of the test is for "therapeutic drug monitoring," which is a common application of IVD tests to measure drug levels in a patient's body fluid.
- Assay System: The description refers to it as an "assay system," which is a term commonly used for IVD tests that involve chemical or biological reactions to measure a substance.
- Use on Specific Analyzers: The mention of use on the Abbott TDx® or TDxFLX® analyzer indicates it's designed to be used with laboratory equipment for performing diagnostic tests.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INNOFLUOR™ Topinamate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay, 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Topiramate concentrations measured by the INNOFLUOR™ Topiramate Assay System (INNOFLUOR™), on the Abbott TDx® analyzer, were compared with those measured by Topinamate Gas Chromatography (GC) on 117 patient samples from patients receiving topiramate therapy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of the patient sample results by linear regression analysis resulted in the recression equation: (INNOFILUOR™) = 0.985 x (GC) - 0.147, with a correlation coefficient of 0.9934, demonstrating equivalency of results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3280 Clinical toxicology control material.
(a)
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.(b)
Classification. Class I (general 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.
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MAY 1 2 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™ Topinamate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.
Substantial equivalence has been demonstrated between the INNOFLUOR™ Topiramate Assay System, the INNOFLUOR™ Phonobarbital Assay System (INNOFLUOR™ Phenobarbital Reagent Set and INNOFLUOR™ Phenobarbital Callbrator Set), the Abbott Phenobarbital II Assay and Topiramate Gas Chromatography.
The technological characteristics, performance and intended use of the INNOFILUOR™ 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 Topinamate Gas Chromatography (GC) on 117 patient samples from patients receiving topiramate therapy. Companison of the patient sample results by linear regression analysis resulted in the recression equation: (INNOFILUOR™) = 0.985 x (GC) - 0.147, with a correlation coefficient of 0.9934, demonstrating equivalency of results.
Contact Person: Lynda M. Tavlor Vice President Quality Assurance and Regulatory Affairs
01/29/97 Date Prepared: