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510(k) Data Aggregation
(115 days)
The ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
The ARK™ Topiramate Calibrator is intended for use in calibration of the ARK Topiramate Assav.
The ARKTM Topiramate Control is intended for use in quality control of the ARK Topiramate Assay.
The ARK Topiramate Assay is a homogeneous immunoassay based on competition between drug in the specimen and topiramate epitope labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme used in the assay.
The ARK Topiramate Assay consists of reagents R1 anti-topiramate polyclonal antibody with substrate and R2 topiramate epitope labeled with bacterial G6PDH enzyme. The ARK Topiramate Calibrator consists of a six-level set to calibrate the assay, and the ARK Topiramate Control consists of a three-level set used for quality control of the assay.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | ≤20% CV with ±15% recovery | 1.5 µg/mL |
| Accuracy (Analytical Recovery) | Percent recoveries within 10% of theoretical levels | All reported values from 1.5 µg/mL to 55.0 µg/mL were within 10% of theoretical (e.g., 95.6% to 107.1% recovery). Example: 1.5 µg/mL recovered 95.6%, 55.0 µg/mL recovered 107.1%. |
| Linearity | Percent difference ≤ ±10% between predicted 1st and 2nd order regressed values | Demonstrated linearity between 1.2 and 54.0 µg/mL. Max % Difference outside this range was -18.14% at 0.6 µg/mL. All values within 1.2-54.0 µg/mL were within ±10%. |
| Assay Range | Not explicitly stated as acceptance criteria, but defined as output. | 1.5 µg/mL to 54.0 µg/mL |
| Precision (Total CV) | <10% total CV | Sample 1 (2.4 µg/mL): 4.2% CVSample 2 (10.2 µg/mL): 2.7% CVSample 3 (40.2 µg/mL): 3.2% CV |
| Interfering Substances | Measurement of topiramate resulted in ≤10% error | All tested substances (e.g., Albumin, Bilirubin, Cholesterol, Hemoglobin) at clinically high concentrations resulted in ≤10% error. |
| Metabolites (Cross-Reactivity) | Measurement of topiramate resulted in ≤10% error | 9-Hydroxy-topiramate at 40.0 µg/mL resulted in 8.6% error for low topiramate and 3.2% error for high topiramate. |
| Drug Interference | Measurement of topiramate resulted in ≤10% error | All tested co-administered drugs (e.g., Acetaminophen, Carbamazepine, Phenobarbital, Valproic Acid) at high concentrations resulted in ≤10% error. |
| Anticoagulants | No significant difference between serum and plasma recovery | Results indicated no significant difference between serum and plasma recovery. |
| Calibration Curve Stability | Not explicitly stated as acceptance criteria, but reported. | Effective up to 49 days. |
| Reagent On-board Stability | Not explicitly stated as acceptance criteria, but reported. | Effective for up to 60 days. |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy: Not explicitly stated as a "test set" in the traditional sense. Samples were human serum negative for topiramate, spiked with known topiramate concentrations. Six replicates were performed for each concentration. Data provenance is implied to be laboratory-generated through spiking.
- Linearity: A 60.0 µg/mL serum sample was prepared and proportionally diluted with human serum negative for topiramate. Topiramate concentrations ranged from 0.6 to 60.0 µg/mL. Data provenance is laboratory-generated.
- Method Comparison: 113 samples.
- Data Provenance: Not explicitly stated for this particular study (e.g., country of origin, retrospective/prospective). However, given the context of a 510(k) for an in vitro diagnostic, these samples would typically come from patients, likely collected retrospectively or prospectively for method validation purposes.
- Precision: Tri-level controls were used. Each level was assayed in quadruplicate, twice a day for 20 days (N=160 for each level). Data provenance is laboratory-generated.
- Interfering Substances: Samples were human serum with known levels of topiramate (approximately 5 and 20 µg/mL) spiked with high concentrations of various interfering substances. Data provenance is laboratory-generated.
- Metabolites: Samples were human serum with known levels of topiramate spiked with 9-hydroxy-topiramate. Data provenance is laboratory-generated.
- Drug Interference: Samples were normal human serum with known levels of topiramate (approximately 5 and 20 µg/mL) spiked with high concentrations of various drug compounds. Data provenance is laboratory-generated.
- Anticoagulants: Not explicitly detailed, but implied to involve testing serum and plasma samples containing topiramate. Data provenance is laboratory-generated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in vitro diagnostic device for quantitative determination of a drug in serum/plasma. The "ground truth" for the test set (e.g., known concentrations for accuracy, reference method results for method comparison) is established through analytical techniques, not expert adjudication of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this device performance is assessed through analytical measurements against known concentrations or a reference method, not through expert adjudication in the context of diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices where human readers interpret cases, and the AI's impact on their performance is evaluated. This device is an automated in vitro diagnostic assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are all standalone validations of the analytical performance of the ARK Topiramate Assay. The device is intended for quantitative determination on automated clinical chemistry analyzers, meaning it operates without direct human-in-the-loop interpretation of its primary output.
7. The Type of Ground Truth Used
The ground truth used for these studies includes:
- Known Reference Concentrations: For accuracy and linearity studies, serum samples were spiked with precisely measured, highly pure topiramate to create samples with known theoretical concentrations.
- Reference Method Results: For the method comparison study, results from the ARK Topiramate Assay were compared against a "commercially available FPIA Immunoassay." The results from this predicate method served as the reference or ground truth for comparison.
- Known Spiked Levels: For interference, metabolite, and drug interference studies, known quantities of the interfering substance, metabolite, or drug were added to samples with known topiramate concentrations.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a predefined assay, not the development or training of a machine learning algorithm. Therefore, there is no "training set" in the context of an AI/ML device. The reagents are pre-formulated for the immunoassay.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as point 8.
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