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510(k) Data Aggregation
(193 days)
The ARK Levetiracetam II 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 ARK Levetiracetam II 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 related 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 coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Levetiracetam II Assay consists of reagents R1 anti-levetiracetam monoclonal antibody with substrate and R2 levetiracetam labeled with bacterial G6PDH enzyme.
The provided text describes the performance of a diagnostic assay (ARK Levetiracetam II Assay), not an AI/ML-enabled medical device. Therefore, many of the requested criteria related to AI/ML evaluation (such as MRMC studies, training set details, expert ground truth establishment for AI) are not applicable.
However, I can extract the relevant acceptance criteria and performance data for this in-vitro diagnostic device:
Device Name: ARK Levetiracetam II Assay
Regulatory Class: Class II
Product Code: ORI
Intended Use: Quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers, as an aid in management of patients treated with levetiracetam.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from study design/CLSI guidelines) | Reported Device Performance (ARK Levetiracetam II Assay) |
|---|---|---|
| Limit of Quantitation (LoQ) | ≤20% CV precision and ±15% recovery | 2.0 µg/mL (at 2.80% CV and 95.0% recovery) |
| Measurement Range | Not explicitly stated as acceptance criterion, but established. | 2.0 - 100.0 µg/mL |
| Recovery | ±10% of the expected sample concentration | All tested concentrations (2.0-100.0 µg/mL) showed %Recovery within ±10% (e.g., 95.0% to 102.6%) |
| Linearity | Percent difference (Deviation) ±10% between predicted and observed results | All tested concentrations (2.0-100.0 µg/mL) showed %Deviation within ±10% (e.g., -6.1% to 9.5%) |
| Precision (Total CV) | <10% Total CV | For all control and human serum samples, Total CV ranged from 1.6% to 2.9% |
| Interfering Substances | ≤10% error (relative to serum control mean result) | All tested interferents showed ≤10% error (e.g., 91.0% to 102.7% recovery) |
| Metabolites (Cross-reactivity) | ≤10% error (relative to serum control mean result) | ucb L057 showed 0.0% cross-reactivity and ≤10% interference (0.8% and 0.1% for 15 and 50 µg/mL Levetiracetam, respectively) |
| Drug Interference (Other Anti-Epileptic/Coadministered Drugs) | ≤10% error (relative to serum control mean result) | All tested drugs (except brivaracetam) showed ≤10% error. |
| Sample Stability | Not explicitly stated (implied sufficient stability for clinical use) | Stable for 48 hours at 22°C, 40 days at 2-8°C, and after 3 freeze/thaw cycles. |
| Product Stability (Shelf-life) | Not explicitly stated (implied sufficient shelf-life) | 18 months when stored unopened at 2-8°C. |
| On-Board Stability (Reagents) | Not explicitly stated (implied sufficient stability) | Stable up to 96 days. |
| Calibration Curve Stability | Not explicitly stated (implied sufficient stability) | Effective up to at least 28 days. |
2. Sample Size Used for the Test Set and Data Provenance
- LoQ: 40 replicates (8 replicates x 5 runs) for each of 3 concentrations (pooled human serum supplemented with levetiracetam).
- Recovery: 6 replicates (3 replicates x 2 analytical runs) for each concentration (human serum negative for levetiracetam, spiked with drug).
- Linearity: 6 replicates (3 replicates x 2 analytical runs) for each dilution (human serum, spiked with drug and diluted).
- Method Comparison: 104 samples (levetiracetam concentrations 3.4 ug/mL to 98.3 ug/mL). No specific provenance (e.g., country of origin) is mentioned, but the samples are clinical human samples or quality control materials. The study is a prospective analytical study comparing two assays.
- Precision: 160 replicates per sample/control level (quadruplicate twice a day for 20 non-consecutive days) for tri-level controls and three human serum samples.
- Interfering Substances: 6 replicates (3 replicates x 2 analytical runs) for each interfering substance level in two known levetiracetam concentrations (human serum).
- Metabolites/Drug Interference: Not explicitly stated, but similar to interfering substances: "high concentration of each compound was spiked into normal human serum with known levels of levetiracetam."
The data provenance is from analytical studies conducted by the manufacturer, likely in a laboratory setting, using human serum/plasma samples/materials. The document does not specify country of origin for the samples/data, beyond "human serum/plasma". These are prospective analytical studies designed to characterize the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This section is not applicable as the document describes an in-vitro diagnostic assay for quantitative determination of a drug. The "ground truth" for such an assay is established by the known concentrations of calibrators, controls, and spiked samples, and comparison to a legally marketed predicate device using analytical methods (e.g., spectrophotometry). There are no human "experts" establishing a "ground truth" in the sense of image interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This is an in-vitro diagnostic device providing quantitative measurements. There is no qualitative assessment or interpretation by multiple readers that would require an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is an in-vitro diagnostic assay, not an AI/ML medical device where human readers interact with AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence. The performance studies (LoQ, Recovery, Linearity, Precision, Interference) demonstrate the "standalone" performance of the assay itself, as an automated clinical chemistry analyzer performs the measurements. There is no human-in-the-loop variable in the measurement process of an immunoassay. The output is a quantitative value, not a diagnostic interpretation that a human would then use as "assistance."
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is primarily:
- Known concentrations: For LoQ, Recovery, Linearity, Interfering Substances, Metabolites, and Drug Interference studies, concentrations of levetiracetam and potential interferents are precisely measured, prepared, or spiked into matrices.
- Reference Method/Predicate Device: For Method Comparison, the predicate ARK Levetiracetam Assay performed on the Roche/Hitachi 917 serves as the comparative "reference" for evaluating the substantial equivalence of the new assay. This is a common practice for IVD assays.
8. The Sample Size for the Training Set
Not applicable. This is a reagent-based immunoassay, not an AI/ML algorithm that requires a training set in the typical sense for machine learning. The "development" or "training" of such a diagnostic involves chemical formulation, antibody development, and optimization of reaction conditions, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no AI/ML training set in this context.
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(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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