(90 days)
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.
The Access BR Monitor assay, Access BR Monitor Calibrators, and the Access Immunoassay analyzers comprise the Dxl 9000 Access Immunoassay Amalyzer for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Dxl 9000 Access Immunoassay Analyzer.
Here's a breakdown of the acceptance criteria and study information for the Access BR Monitor device, based on the provided FDA document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | Not explicitly stated as numerical acceptance criteria for slope, intercept, or correlation coefficient, but inferred by comparison to predicate. | Comparing Dxl 9000 to Access 2: |
- Slope: 0.95 (95% CI: 0.94 - 0.96)
- Intercept: 0.70 (95% CI: 0.31 - 1.4)
- Correlation Coefficient (R): 1.00
(Implied acceptance if comparable to predicate) |
| Imprecision (Within-Laboratory) | - SD ≤ 1.5 U/mL at concentrations ≤ 15 U/mL - CV ≤ 10.0% at concentrations ≥ 15 U/mL | Met acceptance criteria.
- Sample 1 (4.2 U/mL): SD 0.1, CV 3.4%
- Sample 2 (19 U/mL): CV 2.9%
- Sample 3 (34 U/mL): CV 3.2%
- Sample 4 (79 U/mL): CV 3.0%
- Sample 5 (105 U/mL): CV 3.0%
- Sample 6 (425 U/mL): CV 3.2%
- Sample 7 (825 U/mL): CV 4.0% |
| Linearity | Not explicitly stated numerically, but stated as being linear throughout the analytical measuring interval. | Met acceptance criterion, indicating linearity throughout the analytical measuring interval (0.8 – 1,000 U/mL). |
| Limit of Blank (LoB) | 0.4 U/mL | Met acceptance criterion. LoB estimate: 0.1 U/mL. |
| Limit of Detection (LoD) | 0.5 U/mL | Met acceptance criterion. LoD estimate: 0.3 U/mL. |
| Limit of Quantitation (LoQ) | Not explicitly stated numerically, but two different LoQ definitions are provided. | - 20% CV LoQ estimate: 0.3 U/mL - LoQ at 20% within-laboratory imprecision estimate: 0.8 U/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: N = 163 samples.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
- Imprecision:
- Sample 1, 2: N = 126
- Sample 3, 4, 5, 6, 7: N = 120
- Data Provenance: Not specified.
- Linearity, LoB, LoD, LoQ: Sample sizes not explicitly stated for these specific studies, beyond the "N" for method comparison and imprecision.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or ground truth establishment for the test set in the provided document. The studies described are analytical performance studies (method comparison, imprecision, linearity, limits) of an immunoassay device, which typically compare the device's measurements against a reference method or predetermined values, not against expert consensus on clinical diagnoses.
4. Adjudication Method for the Test Set
Not applicable, as the studies are analytical performance assessments of an immunoassay, not studies involving human interpretation or adjudication of clinical cases.
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
No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for measuring CA 15-3 antigen levels, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described (Method Comparison, Imprecision, Linearity, LoB, LoD, LoQ) are all examples of standalone performance evaluations of the immunoassay system. The device itself (Access BR Monitor on the Dxl 9000 Access Immunoassay Analyzer) operates as an "algorithm only" in the sense that it automates the measurement of the analyte; there is no human-in-the-loop for the measurement process itself.
7. The Type of Ground Truth Used
The "ground truth" for these analytical studies is either:
- Reference method/Predicate device results: For the method comparison study, the Access 2 Immunoassay System served as the reference (predicate) for comparison.
- Known concentrations/values: For studies like Imprecision, Linearity, LoB, LoD, and LoQ, calibrated samples or controls with known or expected analyte concentrations are used as the reference against which the device's measurements are assessed. The document refers to "predetermined values" or "calculated estimates" based on established statistical methods (e.g., CLSI guidelines).
8. The Sample Size for the Training Set
Not applicable. This device is an immunoassay, not a machine learning or AI model that requires a "training set." Its calibration is established through a stored calibration curve, as mentioned in the "Comparison of Technological Characteristics" table.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML model for this immunoassay device. The "calibration curve" for the immunoassay is established using calibrators, which are materials with known concentrations of the analyte, manufactured and tested according to quality control standards.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.