(90 days)
The INNOFLUOR™ Topiramate Assay System is an in vitro diagnostic device intended for the quantitative determination of total topiramate in serum or heparinized plasma by fluorescence polarization immunoassay. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® (TDx or TDxFLx®) analyzer.
The INNOFLUOR™ Topiramate Reagent Set is intended for the quantitative determination of total topiramate in serum or heparinized plasma. The reagent set is intended for use in the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Calibrator Set is intended for use in the calibration of the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Reagent Set and Calibrator Set are used together to generate the calibration curve on the TDx or TDxFLx® analyzer. The calibration curve must be established prior to assaying unknown samples. Prior to performing the calibration procedure, the correct analyzer operating parameters must be set by following the instructions provided in the Product Insert Supplement, which is included with every INNOFLUOR™ Topiramate Reagent Set. The INNOFLUOR™ Topiramate Control Set is intended for use in the quality control of the INNOFLUOR™ Topiramate Assay System. The Controls have been selected to best monitor the quality and stability of the calibration curve. The control results must be within established acceptable ranges before patient samples are assayed.
The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay for the quantitative determination of total topiramate in serum or heparinized plasma. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.
Here's a summary of the acceptance criteria and study detailed in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Equivalency Demonstrated Through) | Reported Device Performance (Comparison of Methods) |
|---|---|
| Substantial equivalence to predicate devices (INNOFLUOR™ Phenobarbital Assay System and Abbott Phenobarbital II Assay) in technological characteristics, performance, and intended use. | Linear Regression Analysis: (INNOFLUOR™) = 0.985 x (GC) - 0.147 |
| Correlation Coefficient: 0.9934 | |
| Equivalency of results between the INNOFLUOR™ Topiramate Assay System and Topiramate Gas Chromatography. | Demonstrated by the linear regression analysis and high correlation coefficient. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 117 patient samples.
- Data Provenance: The text states these were "patient samples from patients receiving Topiramate therapy," implying real-world patient data. There is no information provided about the country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable/Not mentioned. The ground truth was established by Topiramate Gas Chromatography (GC), which is a laboratory method, not expert interpretation.
4. Adjudication Method for the Test Set
- Not applicable. The comparison was against a reference laboratory method (GC), not human assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a diagnostic assay, not an AI-assisted interpretation study involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, the study describes the performance of the INNOFLUOR™ Topiramate Assay System (an automated fluorescence polarization immunoassay) when compared directly to Topiramate Gas Chromatography. This is a standalone performance assessment of the device.
7. The Type of Ground Truth Used
- Reference Method/Laboratory Standard: Topiramate Gas Chromatography (GC) was used as the reference method for determining the "true" Topiramate concentrations in the patient samples.
8. The Sample Size for the Training Set
- Not explicitly mentioned. The provided document focuses on the validation of the device, not its development or training process. It's likely that a training set would have been used during the development of the immunoassay, but this information is not included in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
- Not mentioned. As with the training set size, details on how the ground truth was established for any potential training set are not included in this document.
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.