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510(k) Data Aggregation
(237 days)
The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.
The ARK™ Oxcarbazepine Metabolite Calibrator is intended for use in calibration of the ARK Oxcarbazepine Metabolite Assay.
The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended for use in quality control of the ARK Oxcarcarbazepine Metabolite Assay.
For prescription use only. Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.
The ARK Oxcarbazepine Metabolite Assay is a homogeneous immunoassay based on competition between drug in the specimen and Oxcarbazepine Metabolite 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 Oxcarbazepine Metabolite Assay consists of reagents R1 anti-Oxcarbazepine Metabolite polyclonal antibody with substrate and R2 Oxcarbazepine Metabolite labeled with bacterial G6PDH enzyme. The ARK Oxcarbazepine Metabolite Calibrator consists of a six-level set to calibrate the assay, and the ARK Oxcarbazepine Metabolite Control consists of a three-level set used for quality control of the assay.
The provided document describes the performance characteristics of the ARK™ Oxcarbazepine Metabolite Assay, Ark Oxcarbazepine Metabolite Calibrator, and Ark Oxcarbazepine Metabolite Control. This is a 510(k) premarket notification for a medical device (an in-vitro diagnostic assay), not an AI/ML powered device, therefore the information typically requested for AI/ML device studies (such as number of experts, adjudication methods, multi-reader multi-case studies, separate training/test sets with ground truth establishment methods for AI/ML models) are not applicable.
The acceptance criteria and performance data are detailed for several analytical validation studies.
Here's the breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Implicit from CLSI guidelines and successful submission) | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | ≤20% CV with ±15% recovery (according to CLSI EP17-A2) | 1.0 µg/mL |
| Recovery | Desired close agreement between theoretical and recovered concentrations | Generally good, variations with S:R ratio. Example: For S:R 9:1, range 0.98 µg/mL (at 1.0 µg/mL theoretical) to 44.63 µg/mL (at 45.0 µg/mL theoretical). |
| Linearity | Percent difference ±10% between 1st and 2nd order regressed values, or ≤ 0.20 µg/mL below 2.0 µg/mL (according to CLSI/NCCLS Protocol EP6-A) | Linear relationship demonstrated between 1.0 and 50.0 µg/mL (y = 1.0388x -0.0693). All differences within acceptance criteria. |
| Assay Range | Clinically relevant measurable range | 1.0 to 37.0 µg/mL |
| Method Comparison (vs. LC-MS/MS) | Desired strong correlation (slope close to 1, y-intercept close to 0, high r²) (according to CLSI Protocol EP9-A3) | Slope: 1.01 (0.98 to 1.04 95% CI) |
| y-intercept: -0.38 (-0.84 to 0.12 95% CI) | ||
| Correlation Coefficient (r²): 0.95 (0.94 to 0.97 95% CI) | ||
| Precision | ≤10% CV (Total CV) | ARK Control: |
| LOW: 5.7% CV | ||
| MID: 4.8% CV | ||
| HIGH: 5.1% CV | ||
| Human Serum: | ||
| LOW: 5.5% CV | ||
| MID: 5.5% CV | ||
| HIGH: 5.1% CV | ||
| All results meet the ≤10% CV criterion. | ||
| Interfering Substances | ≤10% error in measurement | All tested substances (Human Albumin, Bilirubin, Cholesterol, Human IgG, Hemoglobin, Rheumatoid Factor, Triglycerides, Uric Acid) resulted in ≤10% error. |
| Stability (Serum Specimens) | Defined stability period at various conditions | Stable for at least 48 hours at room temperature (22 °C), 14 days refrigerated (2-8 °C), 3 months frozen (-20 °C), and after 3 freeze/thaw cycles. |
| Calibration Curve Stability | Defined stability period for stored calibration | Effective for at least 15 days. |
2. Sample size used for the test set and the data provenance
- LOQ: Not explicitly stated how many unique samples, but "mean of six (6) replicate measurements" for recovery at different enantiomer ratios.
- Recovery: Not explicitly stated how many unique samples, but "mean of six (6) replicate measurements" of Oxcarbazepine Metabolite was tabulated as a function of the enantiomer ratio.
- Linearity: Not explicitly stated how many unique samples other than a "60.0 µg/mL serum sample was prepared and dilutions were made proportionally."
- Method Comparison: 190 samples.
- Precision: 3 levels of ARK Control (N=160 each) and 3 human serum pooled specimens (N=160 each). This means for each of the 6 material types, 160 measurements were taken (quadruplicate twice a day for 20 days).
- Interfering Substances: Not explicitly stated the number of unique human serum samples, but substances were tested "in serum with known levels of Oxcarbazepine Metabolite (approximately 3 and 30 µg/mL)."
- Specificity & Drug Interference: Not explicitly stated how many unique human serum samples, but tested with spiked compounds into normal human serum with known Oxcarbazepine Metabolite levels.
- Sample Stability & Calibration Curve Stability: "supporting data" cited, but specific sample sizes are not provided within this document.
Data Provenance: The document does not specify the country of origin of the human serum samples. The studies are analytical validations performed retrospectively in a laboratory setting (e.g., Beckman Coulter AU480® automated clinical chemistry analyzer). It's not a prospective clinical trial with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is an analytical chemistry assay validation, not a diagnostic imaging AI/ML model. Therefore, "experts" in the sense of physicians establishing ground truth for patient cases are not applicable. The "ground truth" for the test set (e.g., concentration of Oxcarbazepine Metabolite) is established by highly accurate reference methods such as LC-MS/MS (for method comparison) or by precise gravimetric/volumetric preparation of controls and calibrators using certified reference materials. The qualifications of the personnel performing these analytical tests are implicitly assumed to be those typical for a laboratory setting conducting such validations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an analytical validation of an in-vitro diagnostic assay measuring a chemical concentration, not a study involving human readers or subjective interpretations 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 an analytical validation of an in-vitro diagnostic assay, not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is an "algorithm only" in the sense that it is an automated chemical assay system. Its performance (quantification of Oxcarbazepine Metabolite) is assessed independently through the various analytical studies (e.g., LOQ, linearity, precision, method comparison against LC-MS/MS). Human "human-in-the-loop" performance is not a direct component of the assay's function, though human operators are involved in running the assay and interpreting the results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the analytical performance studies is primarily:
- Reference Method: For method comparison, LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is used as the reference "ground truth" method. LC-MS/MS is a highly accurate and precise analytical technique for quantifying specific compounds in complex mixtures.
- Gravimetric/Volumetric Preparation: For calibrators and controls, the "ground truth" concentrations are established by precise gravimetric addition of certified Oxcarbazepine Metabolite powder to solvents. Purity is determined by NMR and elemental analysis.
8. The sample size for the training set
This is an immunoassay, not a machine learning or AI algorithm in the traditional sense that requires a "training set" for model development. The "training" of the assay refers to its calibration. The calibrators are prepared and value-assigned as described (e.g., "Two calibrated runs are performed using the Master Calibrator. In each run, five replicates of Master Lot (reference) and Test Lot are tested as matched pairs for each calibrator level.").
9. How the ground truth for the training set was established
As described above, for an immunoassay, the "training set" is the calibrator set. The ground truth for the calibrators is established through:
- Traceability to certified powder: The calibrators are traceable to certified Oxcarbazepine Metabolite powder. "The purity of Oxcarbazepine Metabolite in the certified raw material is determined by NMR and elemental analysis as performed by the supplier of the certified powder."
- Gravimetric Addition: "Bulk solutions of the ARK Oxcarbazepine Metabolite Calibrator are prepared volumetrically using a stock solution prepared by gravimetric addition of powder to solvent."
- Value Assignment: "Testing is performed with the ARK Oxcarbazepine Metabolite Assay on the Beckman Coulter AU480® automated analyzer. Two calibrated runs are performed using the Master Calibrator. In each run, five replicates of Master Lot (reference) and Test Lot are tested as matched pairs for each calibrator level. Mean values for ten replicates are calculated." This process ensures consistency and accuracy against a master reference.
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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 |
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