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510(k) Data Aggregation
(146 days)
The ARK™ Levetiracetam Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with levetiracetam. The ARKTM Levetiracetam Calibrator is intended for use in calibration of the ARK Levetiracetam Assay. The ARK™ Levetiracetam Control is intended for use in quality control of the ARK Levetiracetam Assay.
The ARK Levetiracetam Assay is a homogeneous immunoassay based on competition between drug in the specimen and levetiracetam 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 Levetiracetam Assay consists of reagents RI anti-levetiracetam polyclonal antibody with substrate and R2 levetiracetam labeled with bacterial G6PDH enzyme. The ARK Levetiracetam Calibrator consists of a six-level set to calibrate the assay, and the ARK Levetiracetam Control consists of a three-level set used for quality control of the assay.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for ARK™ Levetiracetam Assay
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 | 2.0 µg/mL (not explicitly stated if it met the 20% CV & ±15% recovery, but implied as the determined LOQ) |
| Accuracy (Analytical Recovery) | Not explicitly stated, but implied to be acceptable based on percent recovery within reasonable limits. | Range of 94.6% to 105.3% recovery for concentrations 2.0 to 100.0 µg/mL. |
| Linearity | Percent difference ±10% between 1st and 2nd order regressed values, or ±15% below 3.0 µg/mL. | Linear relationship demonstrated between 2.0 and 100.0 µg/mL. All % Differences were within the specified ±10% (for values ≥3.0 µg/mL) and ±15% (for values <3.0 µg/mL, observed at 13.2% for 2.0 µg/mL which is within 15%). |
| Precision | <10% total CV | ARK Levetiracetam Control:LOW (7.5 µg/mL): 4.5% total CVMID (29.4 µg/mL): 3.7% total CVHIGH (73.4 µg/mL): 4.2% total CVHuman Serum:LOW (6.9 µg/mL): 4.8% total CVMID (30.2 µg/mL): 4.1% total CVHIGH (75.5 µg/mL): 4.4% total CV |
| Interfering Substances | Measurement of levetiracetam resulted in ≤10% error. | Measurement of levetiracetam resulted in ≤10% error in the presence of tested interfering substances (Albumin, Bilirubin, Cholesterol, Gamma-Globulin, Hemoglobin, Intralipid®, Rheumatoid Factor, Triglycerides, Uric Acid). |
| Metabolite Cross-Reactivity (ucb L057) | Measurement of levetiracetam resulted in ≤10% error. | Measurement of levetiracetam resulted in ≤10% error. Specifically, percent interference was -3.0% (at 15 µg/mL Levetiracetam) and 6.6% (at 50 µg/mL Levetiracetam). Percent cross-reactivity was -0.2% and 1.3%. |
| Drug Interference | Measurement of levetiracetam resulted in ≤10% error. | Measurement of levetiracetam resulted in ≤10% error in the presence of various anti-epileptic or co-administered drugs tested. All percentage recoveries listed for 15 µg/mL and 50 µg/mL Levetiracetam were within 10% of the expected value (i.e., between 90% and 110%). |
| Anticoagulants | No significant difference between recovery in serum or plasma. | Results indicate no significant difference between the recovery of levetiracetam in serum or plasma. |
| Sample Stability | Not explicitly stated beyond "stable for at least...". | Stable for at least 48 hours at room temperature (22 °C), 40 days when refrigerated (2-8 °C), and after three successive freeze/thaw cycles. |
| Calibration Curve Stability | Not explicitly stated beyond "effective up to...". | Effective up to 40 days. |
| Reagent On-Board Stability | Not explicitly stated beyond "effective for up to at least...". | Effective for up to at least 40 days. |
2. Sample Size and Data Provenance
- Accuracy: Not explicitly stated, but "highly pure levetiracetam was added volumetrically to human serum negative for levetiracetam, representing drug concentrations across the assay range." Six replicates of each sample were assayed. Data provenance not specified (retrospective/prospective, country of origin).
- Linearity: Not explicitly stated, but a 100.0 µg/mL serum sample was prepared and dilutions were made proportionally with human serum negative for levetiracetam. Data provenance not specified.
- Method Comparison: Number of samples = 305. Data provenance not specified.
- Precision: 160 measurements for each of the 6 levels (3 control levels, 3 human serum pools). This equates to 8 measurements per level per day (quadruplicate twice a day) over 20 days. Data provenance not specified.
- Interfering Substances: For each interfering substance, serum with known levels of levetiracetam (approx. 15 and 50 µg/mL) was evaluated. A serum control was also used. Amount of samples for each interfering substance is not explicitly stated. Data provenance not specified.
- Metabolites: Not explicitly stated for metabolite cross-reactivity. Data provenance not specified.
- Drug Interference: For each compound, normal human serum with known levels of levetiracetam (approx. 15 and 50 µg/mL) was spiked and assayed along with a serum control. Total number of samples is not explicitly stated. Data provenance not specified.
- Anticoagulants: Not explicitly stated. Data provenance not specified.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is an in-vitro diagnostic device (immunoassay) for quantitative determination of a drug. Ground truth is established by spiked concentrations, a reference method (LC/MS/MS), or intrinsic characteristics of known substances. No human expert interpretation of images or other subjective data is involved.
4. Adjudication Method
Not applicable. For an immunoassay, the "ground truth" is typically verifiable concentrations of the analyte or comparison to a gold standard analytical method. There is no subjective assessment that would require expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in-vitro diagnostic device for quantitative chemical analysis, not an imaging device or a device involving human interpretation where MRMC studies would be relevant.
6. Standalone Performance
Yes, the studies described are solely for the performance of the ARK™ Levetiracetam Assay system (algorithm/device only). There is no "human-in-the-loop" component to its stated intended use or the performance studies presented.
7. Type of Ground Truth Used
- Limit of Quantitation, Accuracy, Linearity, Interfering Substances, Metabolites, Drug Interference: Ground truth was established by known, spiked concentrations of levetiracetam and/or interfering substances into human serum, or by using highly pure reference materials.
- Method Comparison: Ground truth for comparison was established by a reference LC/MS/MS method.
- Precision: Ground truth was established by known concentrations in control materials and pooled human serum samples.
8. Sample Size for the Training Set
Not applicable. This is an immunoassay, which does not typically involve training a machine learning model in the same way as, for example, an AI for image analysis. The "training" in this context would be the development and optimization of the chemical reagents and assay parameters during the R&D phase, for which specific sample sizes and datasets for "training" are not usually reported in this manner.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not a machine learning device that uses a "training set" in the conventional sense. The "ground truth" for the development of the assay would involve fundamental chemical and biological principles to ensure proper antibody-antigen binding specificity and enzyme activity, calibrated against known standards.
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