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510(k) Data Aggregation
(261 days)
ARK Methotrexate Assay
The ARK™ Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of methotrexate to help ensure appropriate therapy.
Specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy should not be tested with the ARK Methotrexate Assay.
The ARK Methotrexate Assay is a homogeneous immunoassay based on competition between drug in the specimen and Methotrexate 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 coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Methotrexate Assay consists of reagents R1 anti-Methotrexate polyclonal antibody with substrate and R2 Methotrexate labeled with bacterial G6PDH enzyme. The ARK Methotrexate Calibrator consists of a six-level set to calibrate the assay, and the ARK Methotrexate Control consists of a six-level set used for quality control of the assay (tri-level calibration range set and tri-level high range set). The ARK Methotrexate Dilution Buffer is equivalent to zero calibrator (Calibrator A).
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Acceptance Criteria and Device Performance for ARK™ Methotrexate Assay
The provided document describes the acceptance criteria and the study that proves the ARK™ Methotrexate Assay, when used on the Beckman Coulter AU680 analyzer, meets these criteria. The study aims to demonstrate substantial equivalence to the assay's performance on the predicate device, the Roche/Hitachi 917 analyzer.
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The pre-determined Pass/Fail acceptance criteria were met for all of the above performance studies." However, the specific numerical acceptance criteria or performance values for each characteristic are not provided in the given text. It only lists the types of performance characteristics evaluated.
| Performance Characteristic | Acceptance Criteria (Not Detailed) | Reported Device Performance |
|---|---|---|
| Limit of Blank | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Limit of Detection | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Limit of Quantitation | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Recovery | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Linearity | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Accuracy (Method Comparison) | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Precision | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Specificity | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Cross-reactivity | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Carry-over | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| Dilution Recovery | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
| On-board Stability | Undisclosed Pass/Fail Criteria | Met Acceptance Criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test set for any of the performance studies.
The document refers to "human serum or plasma" as the sample type. The country of origin of the data is not explicitly stated. The study is a "validation and verification" activity, implying it was conducted specifically for this submission, likely making it a prospective study for the purpose of device validation.
3. Number of Experts and Qualifications for Ground Truth
The concept of "experts" and their qualifications for establishing ground truth, as typically seen in image analysis or diagnostic interpretation, is not applicable to this type of in vitro diagnostic device (immunoassay) study. The ground truth for this device's performance characteristics is established through analytical methods and reference standards, not expert interpretation.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable to this type of in vitro diagnostic device (immunoassay) study. Performance is assessed through quantitative measurements against established analytical criteria, not through expert consensus on diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of in vitro diagnostic device (immunoassay). This study design is typically used for imaging or diagnostic interpretation tasks where human readers' performance is being evaluated, often with and without AI assistance. This device is an automated assay, not an AI for human interpretive tasks.
6. Standalone (Algorithm Only) Performance Study
The study described is a standalone performance study for the algorithm (assay system) on the Beckman Coulter AU680 analyzer. The validation and verification activities listed (Limit of Blank, Limit of Detection, Accuracy, Precision, etc.) directly evaluate the performance of the device itself, without human interpretation in the loop. The purpose is to demonstrate that the assay system alone performs comparably to its predicate.
7. Type of Ground Truth Used
For an immunoassay like the ARK™ Methotrexate Assay, the "ground truth" for evaluating its performance characteristics (analytical accuracy, precision, linearity, etc.) would be established through:
- Reference materials/standards: Calibrators and controls with precisely known concentrations of methotrexate.
- Reference methods: Comparison with established, validated analytical methods (e.g., LC-MS/MS, or the predicate device's performance which was previously validated) for samples with unknown concentrations.
- Spiking studies: Adding known amounts of analyte to a sample and measuring recovery to assess accuracy.
The document implicitly refers to these as part of the "analytical performance studies" and "validation and verification activities."
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This is expected as the ARK™ Methotrexate Assay is a homogeneous enzyme immunoassay kit, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a system would involve validating its components and establishing its operational parameters on the target analyzer.
9. How Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of machine learning, this question is not applicable. The assay is a chemical and biological system where parameters are set based on chemical principles and reagent characteristics, and then validated through performance studies.
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(105 days)
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL
The ARK™ Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Methotrexate in human serum or automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of methotrexate to help ensure appropriate therapy.
The ARK™ Methotrexate Calibrator is intended for use in calibration of the ARK Methotrexate Assay.
The ARKTM Methotrexate Control is intended for use in quality control of the ARK Methotrexate Assay.
Specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy should not be tested with the ARK Methotrexate Assay.
The ARK Methotrexate Assay is a homogeneous immunoassay based on competition between drug in the specimen and Methotrexate 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 Methotrexate Assay consists of reagents R1 anti-Methotrexate polyclonal antibody with substrate and R2 Methotrexate labeled with bacterial G6PDH enzyme. The ARK Methotrexate Calibrator consists of a six-level set to calibrate the assay, and the ARK Methotrexate Control consists of a six-level set used for quality control of the assay (tri-level calibration range set and tri-level high range set). The ARK Methotrexate Dilution Buffer is equivalent to zero calibrator (Calibrator A).
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LoQ) | LoB LoD met) | |
| Accuracy (Analytical Recovery) | Not explicitly stated as a numerical criterion in the "Acceptance Criteria" section for each data point, but typically implied to be close to 100% recovery. | Mean percentage recovery: 102.1% (Individual recoveries ranged from 98.3% to 111.1%) |
| Linearity | Percent difference was ±10% between the predicted 1st and 2nd order regressed values for concentrations >0.10 µmol/L or ±0.01 µmol/L at concentrations ≤ 0.10 µmol/L. | All observed differences for concentrations >0.10 µmol/L were within ±10% (-2.3% to 4.8%). |
| All observed differences for concentrations ≤ 0.10 µmol/L were within ±0.01 µmol/L (-0.010 µmol/L to -0.004 µmol/L). The highest theoretical concentration tested was 1.30 µmol/L. Regression of assayed methotrexate concentrations was linear throughout the range of 2 to 1200 µmol/L when proportionally diluted. | ||
| Assay Range | Not explicitly stated as an acceptance criterion, but the functional range. | Measurement range: 0.04 - 1.20 µmol/L |
| Method Comparison | Not explicitly stated as a numerical acceptance criterion (e.g., minimum correlation coefficient or confidence intervals for slope/intercept), but comparison to a predicate device is expected. | Range 0.04 to 1.19 µM (102 samples): |
| Slope: 1.00 (95% CI: 1.00 to 1.02) | ||
| y-intercept: 0.01 (95% CI: 0.00 to 0.01) | ||
| Correlation Coefficient (r²): 0.978 (95% CI: 0.968 to 0.985) | ||
| Range 0.04 to 1440 µM (147 samples, including diluted): | ||
| Slope: 0.99 (95% CI: 0.96 to 1.00) | ||
| y-intercept: 0.01 (95% CI: 0.01 to 0.01) | ||
| Correlation Coefficient (r²): 0.998 (95% CI: 0.997 to 0.998) | ||
| Precision | 0.10 µmol/L | |
| SD ≤0.01 at ≤0.10 µmol/L | All control and patient pool samples met the criteria: |
- ARK Methotrexate Control (MID, HIGH, 5, 50, 500 µmol/L): Total CVs ranged from 3.8% to 7.0%.
- ARK Methotrexate Control (LOW, 0.06 µmol/L): Total SD was 0.007, which is ≤0.01.
- Patient Pool (MID, HIGH, 5, 50, 500 µmol/L): Total CVs ranged from 5.3% to 7.2%.
- Patient Pool (LOW, 0.07 µmol/L): Total SD was 0.008, which is ≤0.01. |
| Interfering Substances | Not substantially affected by tested endogenous substances. | Measurement of methotrexate was not substantially affected by clinically high concentrations of Albumin, Bilirubin (conjugated & unconjugated), Cholesterol, Gamma-Globulin, Hemoglobin, Intralipid®, Rheumatoid Factor, Triglycerides, and Uric Acid. |
| Specificity - Crossreactivity |
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