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510(k) Data Aggregation
(172 days)
The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Lamotrigine concentrations can be used as an aid in management of patients treated with lamotrigine.
The ARKTM Lamotrigine Calibrator is intended for use in calibration of the ARK Lamotrigine Assay.
The ARKTM Lamotrigine Control is intended for use in quality control of the ARK Lamotrigine Assay.
The ARK Lamotrigine Assay is a homogeneous immunoassay based on competition between drug in the specimen and lamotrigine 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 Lamotrigine Assay consists of reagents R1 anti-lamotrigine polyclonal antibody with substrate and R2 lamotrigine labeled with bacterial G6PDH enzyme. The ARK Lamotrigine Calibrator consists of a six-level set to calibrate the assay, and the ARK Lamotrigine Control consists of a three-level set used for quality control of the assay.
The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lamotrigine in human serum or plasma. The device performance was evaluated through various studies, including limit of quantitation (LOQ), assay range, recovery, linearity, method comparison, precision, interfering substances, specificity, and anticoagulant studies.
1. Acceptance Criteria and Reported Device Performance:
| Study/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | <20% CV with ±15% recovery | 0.85 µg/mL |
| Assay Range | Not explicitly stated as acceptance criteria, but defined as the operational range. | 0.85 to 40.00 µg/mL |
| Recovery | Not explicitly stated as acceptance criteria, but individual recovery values are presented. | Mean percent recovery: 99.2%. Individual recoveries ranged from 95.8% to 105.1%. |
| Linearity | Percent difference ±10% between predicted and 2nd order regressed values. | All tested concentrations showed a percentage difference within ±10% (range -0.4% to 7.1%). |
| Method Comparison (Study 1 - HPLC) | Not explicitly stated as acceptance criteria, but presented with 95% confidence limits. | Slope: 1.01 (0.99 to 1.03), y-intercept: 0.37 (0.22 to 0.55), Correlation Coefficient (r²): 0.97 (0.96 to 0.98) |
| Method Comparison (Study 2 - Turbidimetric Immunoassay) | Not explicitly stated as acceptance criteria, but presented with 95% confidence limits. | Slope: 0.93 (0.89 to 0.97), y-intercept: 0.41 (0.07 to 0.74), Correlation Coefficient (r²): 0.96 (0.94 to 0.97) |
| Precision | ≤10% total CV | All tested samples (low, mid, high controls, and human serum pools) showed total CVs well within 10% (range 4.1% to 8.8%). |
| Interfering Substances | ≤10% error in the presence of interfering substances. | Measurement of lamotrigine resulted in ≤10% error in the presence of various interfering substances (e.g., albumin, bilirubin, cholesterol, hemoglobin, etc.) at tested levels. |
| Specificity (Metabolites) | Not explicitly stated as acceptance criteria for cross-reactivity percentage. | Metabolites showed low cross-reactivity: Lamotrigine-2-N-glucuronide (1.09-2.91%), Lamotrigine-2-N-methyl (0.02-0.24%), Lamotrigine-2-N-oxide (1.30-3.94%). |
| Specificity (Drug Interference) | ≤10% error in the presence of co-administered drugs. | Measurement of lamotrigine resulted in ≤10% error in the presence of a wide range of co-administered drugs at tested levels. |
| Cross-Reacting Drug (Trimethoprim) | Caution advised if trimethoprim is administered, no explicit error threshold for this specific drug. | Trimethoprim at 40.0 µg/mL showed 4.4% cross-reactivity at 3 µg/mL lamotrigine and 3.0% cross-reactivity at 15 µg/mL lamotrigine. Percentage recovery was 156.0% (at 3 µg/mL Lamotrigine) and 108.0% (at 15 µg/mL Lamotrigine), indicating significant interference. |
| Anticoagulants | No significant difference between serum and plasma recovery. | Results indicated no significant difference between the recovery of lamotrigine in serum or plasma. |
| Sample Stability | Defined stability periods. | Serum specimens stable for at least 6 months frozen, 50 hours at room temperature (22°C), 37 days refrigerated (2-8°C), and after 3 freeze/thaw cycles. |
| On-Board Stability (Calibration Curve) | Calibration curve stability for 30 days. | Calibration curve stability for a period of 30 days is supported by data. |
| On-Board Stability (Reagent) | Reagents effective for up to 30 days. | Reagents were effective when stored on-board for up to at least 30 days. |
| On-Board Stability (Calibrator/Controls) | In-use stability demonstrated; 12 months opened at 2-8°C after accelerated stability. | In-use stability of calibrators and controls was demonstrated. Accelerated OPEN stability at 37°C for 7 days showed stability. Once opened, vials may be stored at 2-8°C for 12 months. |
2. Sample Size and Data Provenance for Test Set:
- Recovery: Not explicitly stated, but "six replicates of each sample" were assayed across various concentrations, implying a total of 48 individual assays. Data provenance is human serum negative for lamotrigine, spiked with concentrated drug.
- Linearity: Not explicitly stated, but dilutions from a 48.00 µg/mL serum sample were made. Data provenance is human serum negative for lamotrigine, spiked with drug.
- Method Comparison (Study 1 - HPLC): 193 samples. Provenance not explicitly stated (e.g., country of origin, retrospective/prospective), but implied to be clinical samples or samples prepared to simulate clinical range.
- Method Comparison (Study 2 - Turbidimetric Immunoassay): 77 samples. Provenance not explicitly stated.
- Precision: Tri-level controls and three human serum pooled specimens. Each level assayed in quadruplicate twice a day for 20 days (160 measurements per control/pool level).
- Interfering Substances: Clinically high concentrations of substances in human serum with known lamotrigine levels (approximately 3 and 15 µg/mL).
- Specificity (Metabolites): Metabolites spiked into two separate samples each containing low (3 µg/mL) and high (15 µg/mL) therapeutic levels of lamotrigine.
- Specificity (Drug Interference): High concentration of each compound spiked into normal human serum with known lamotrigine levels (approximately 3 and 15 µg/mL).
- Anticoagulants: Not explicitly stated but implies a set of serum and plasma samples were tested.
- Sample Stability: Not explicitly stated, but samples were subject to various conditions (frozen, room temp, refrigerated, freeze/thaw cycles).
3. Number of Experts and their Qualifications for Ground Truth:
This type of device (quantitative immunoassay) relies on analytical performance against established reference methods or known concentrations, rather than expert interpretation of images or clinical data. Therefore, the concept of "experts establishing ground truth" as it applies to subjective assessments is not directly applicable here. The ground truth for analytical studies like recovery and linearity are based on gravimetric dilutions/known concentrations, and for method comparisons, the reference methods themselves (HPLC, predicate immunoassay) serve as the comparative standard.
4. Adjudication Method for the Test Set:
Not applicable for this type of analytical device validation. The studies involve quantitative measurements and comparisons to reference methods or known values, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices requiring human interpretation of results, such as imaging studies, where the AI's effect on human reader performance is evaluated. This device is an automated immunoassay for quantitative measurement.
6. Standalone (Algorithm Only) Performance:
Yes, the entire submission describes the standalone performance of the ARK™ Lamotrigine Assay. The studies (LOQ, assay range, recovery, linearity, method comparison, precision, interference, specificity, stability) evaluate the device's analytical performance independently. The device operates on automated clinical chemistry analyzers without human intervention for result generation.
7. Type of Ground Truth Used:
- Known Concentrations/Gravimetric Dilutions: For studies such as Limit of Quantitation, Recovery, Linearity, Precision, Interfering Substances, Specificity (Metabolites, Drug Interference), and Anticoagulants, the ground truth is established by preparing samples with known, precise concentrations of lamotrigine or interfering substances through gravimetric dilutions.
- Reference Methods: For method comparison studies, the reference methods are High Performance Liquid Chromatography (HPLC) and a predicate turbidimetric immunoassay (QMS® Lamotrigine, K062966).
8. Sample Size for the Training Set:
Not applicable. This device is a quantitative immunoassay with "wet lab" validation, not an AI/ML algorithm that typically requires a large clinical "training set" to learn patterns. The validation process involves demonstrating analytical performance against known standards and comparative methods.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there isn't a "training set" in the context of an AI/ML algorithm. The device's analytical characteristics are determined through laboratory experiments using carefully prepared samples with known concentrations or by comparison to reference methods.
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