(90 days)
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No
The summary describes a fluorescence polarization immunoassay for therapeutic drug monitoring, which is a standard laboratory technique. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
This device is an immunoassay system designed for quantitative determination and monitoring of therapeutic drug levels, not for treating a condition.
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 falls under the definition of a diagnostic device as it measures substances to aid in disease management or diagnosis.
No
The device is an immunoassay system consisting of reagents, calibrators, and controls, intended for use on specific hardware analyzers (Abbott TDx® or TDxfLx®). It is a chemical assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is "intended for the quantitative determination of total topiramate in serum or heparinized plasma". This indicates that the device is used to test samples taken from the human body (in vitro) to provide information about a person's health status (diagnostic).
- Sample Type: The assay uses "serum or heparinized plasma", which are biological samples taken from a patient.
- Purpose: The purpose is "therapeutic drug monitoring", which is a diagnostic process used to optimize drug therapy for a patient.
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in senum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxfLx® analyzer.
Product codes
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Device Description
Fluorescence Polarization Immunoassay, Topiramate
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
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Summary of Performance Studies
Comparison of the patient sample results by linear regression analysis resulted in the regression equation: (INNOFLUOR™) = 0.985 x (GC) - 0.147, with a correlation coefficient of 0.9934, demonstrating equivalency of results.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3200 Clinical toxicology calibrator.
(a)
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.)(b)
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.
0
AY 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.
Topiramate Fluorescence Polarization Immunoassay Common or Usual Name:
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 senum or heparinized plaama 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 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 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: (INNOFLUOR™) = 0.985 x (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 |
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| Date Prepared: | 01/29/97 |