Search Results
Found 1 results
510(k) Data Aggregation
(44 days)
The Access® OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access® Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
The Access® OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access® Immunoassay Systems.
Acceptance Criteria and Device Performance for Access® OV Monitor ELISA
This document outlines the acceptance criteria and the performance of the Access® OV Monitor assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Specificity (Therapeutic Drugs) | No significant interference (<10% change) from specified therapeutic drugs. | Doxorubicin (100 µg/mL), Amthopterin (500 μg/mL), Carboplatin (1000 μg/mL), Cyclophosphamide (1000 μg/mL), 5-Fluorouracil (1000 µg/mL), Cisplatin (2000 µq/mL), Melphalan (100 µg/mL), Acetominopehn (200 µg/mL), Aspirin (500 µg/mL), Paclitaxel (10 ng/mL), Biotin (50 ng/mL), Vitamin D2 (1 U/mL) all showed no significant interference. |
| Specificity (Sample Contaminants) | No significant interference (<10% change) from specified sample contaminants. | Total protein (9%), Bilirubin (20 mg/dL), Hemoglobin (1000 mg/dL), and Triglycerides (1800 mg/dL) all showed no significant interference. |
| Analytical Sensitivity (Lowest Detectable Level) | Distinguishable from zero. | 0.2 U/mL (Calibrator S0). |
| Analytical Sensitivity (Claimed in Labeling) | 0.5 U/mL. | |
| Measurement Range | Accurate measurement between lower limit of detection and highest calibrator value. | Approximately 0.5 U/mL to 5,000 U/mL. |
| Recovery (Linearity Studies) | Average recovery within an acceptable range, with individual recoveries also acceptable. | Average recovery of 107%, with individual recoveries ranging from 100% to 118%. |
| Precision (Within-run Imprecision) | Coefficient of Variation (CV) within acceptable limits for various concentrations. | Ranged from 1.3% CV to 2.4% CV for concentrations from ~24 to 2962 U/mL. |
| Precision (Between-run Imprecision) | CV within acceptable limits. | Ranged from 3.3% CV to 6.0% CV. |
| Precision (Total Imprecision) | CV within acceptable limits. | Ranged from 3.9% CV to 6.0% CV. |
| Method Comparison | ||
| Correlation (vs. Predicate Device) | Acceptable correlation coefficient (r). | r = 0.9871 (compared to Abbott Axsym CA 125 assay). |
| Bias (vs. Predicate Device) | Acceptable bias (slope, intercept). | y = 1.197 + (-0.985) across the range of the Axsym assay (0 - 600 U/mL). |
| Clinical Performance | ||
| Clinical Sensitivity (vs. Predicate Device) | Comparable to predicate device. | 84.4% (95% CI = 71.2% - 92.3%) |
| Clinical Specificity (vs. Predicate Device) | Comparable to predicate device. | 82.5% (95% CI = 82.5% - 90.0%) |
| Monitoring Ovarian Cancer Patients | CA 125 concentrations obtained with the device should be comparable and parallel those of the FDA cleared predicate device. | Results from 20 female subjects with ovarian cancer (stages I to IV), monitored for 7-53 months, demonstrated comparable and paralleled CA 125 concentrations to the FDA cleared predicate device. |
2. Sample Size for Test Set and Data Provenance
- Specificity (Therapeutic Drugs & Sample Contaminants): The exact number of samples tested for each compound/contaminant is not specified, but the compounds themselves are listed. Each compound was tested at a specific concentration.
- Analytical Sensitivity: Not explicitly stated as a separate "test set" but likely derived from a series of dilutions or measurements around the lower limit.
- Recovery: 6 human serum samples.
- Precision: Not explicitly stated as a separate "test set" size, but concentrations from 24 to 2962 U/mL were tested, implying multiple measurements at these levels.
- Correlation: 290 samples.
- Clinical Data (Sensitivity & Specificity): The total number of subjects used to calculate clinical sensitivity and specificity is not explicitly stated, but it is derived from the comparison between the Access OV Monitor and the Abbott Axsym CA 125 assays.
- Clinical Data (Monitoring): 20 female subjects diagnosed with ovarian cancer (stages I to IV).
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, although the monitoring study for clinical data implies a prospective approach over an extended period (7 to 53 months).
3. Number of Experts for Ground Truth and Qualifications
This information is not provided in the given text. For an immunoassay, the "ground truth" is typically established by the reference measurement method itself or by clinical diagnosis, rather than by human expert interpretation of an image or a complex medical case.
4. Adjudication Method
This information is not applicable as the studies described pertain to an in vitro diagnostic immunoassay, not a device requiring interpretation or adjudication by human experts in the context of a "test set" like in radiological imaging. The "truth" for this type of device is based on analytical measurements and correlation with an existing, cleared device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted, and therefore, the effect size of human readers improving with AI assistance is not applicable. This type of study design is typically used for imaging diagnostics where human interpretation is a critical component, not for quantitative immunoassays.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. All the analytical performance studies (Specificity, Analytical Sensitivity, Recovery, Precision) and the correlation study against the Abbott Axsym CA 125 assay represent the standalone performance of the Access® OV Monitor assay. The clinical sensitivity and specificity calculations also reflect the standalone performance of the device in comparison to a predicate.
7. Type of Ground Truth Used
- Analytical Performance (Specificity, Analytical Sensitivity, Recovery, Precision): The ground truth was established through reference analytical methods and standards (e.g., spectrophotometry for total protein, known concentrations of therapeutic drugs, calibrated reference materials).
- Correlation: The ground truth was based on the quantitative results obtained from the Abbott Axsym CA 125 assay, which served as the predicate device.
- Clinical Data (Sensitivity & Specificity): The ground truth for disease status (ovarian cancer) would have been established by clinical diagnosis, possibly confirmed by pathology or other definitive medical diagnoses. The specific method for determining "true positive" and "true negative" cases is not detailed but would align with clinical standards.
- Clinical Data (Monitoring): The ground truth for monitoring effectiveness was implicitly established by comparing the CA 125 concentration trends to clinical outcomes and the trends observed with the FDA-cleared predicate device against the known disease progression of the 20 ovarian cancer patients.
8. Sample Size for Training Set
This information is not provided in the document. For an in vitro diagnostic assay like this, "training set" typically refers to studies performed during the development and optimization phase, rather than a distinct, formally reported dataset as seen in machine learning applications.
9. How the Ground Truth for the Training Set Was Established
As the concept of a formal "training set" for this type of immunoassay is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided. However, during the development of such an assay, internal studies would use well-characterized samples (e.g., spiked samples, clinical samples with known CA 125 levels from reference methods, samples from patients with confirmed clinical status) to optimize reagents, calibrate signals, and establish initial operating parameters.
Ask a specific question about this device
Page 1 of 1