(85 days)
Access Thyroglobulin assay is a paramagetic particle, chemiluminescent immunossay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
The Access Thyroglobulin assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Thyroglobulin Sample Diluent, substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
Lumi-Phos PRO substrate was used with this pack. The modification does not affect the indications of the device or alter the fundamental scientific technology of the device.
The provided text is a 510(k) summary for the Access Thyroglobulin assay, which is a diagnostic device and not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies, such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set," are not applicable.
However, I can extract the relevant information regarding acceptance criteria and study results for this diagnostic device.
Acceptance Criteria and Reported Device Performance for Access Thyroglobulin Assay (K240927)
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit from reported results and CLSI guidelines) | Reported Device Performance (Access Thyroglobulin on Dxl 9000) |
|---|---|---|
| Method Comparison | Slope of 1.00 (95% CI covering 1.00); Intercept of 0.00 (95% CI covering 0.00); High Correlation Coefficient (R close to 1.00) | Slope: 1.00 (0.99 - 1.00); Intercept: 0.0044 (-0.029 - 0.021); Correlation Coefficient R: 1.00 |
| Imprecision (Within-lab/Total) | CV ≤ 10.0% at concentrations > 1.0 ng/mL; SD ≤ 0.1 ng/mL at concentrations ≤ 1.0 ng/mL | Achieved across all tested concentrations (e.g., 8.4% at 0.30 ng/mL, 6.8% at 5.5 ng/mL, 6.3% at 22 ng/mL, 2.5% at 111 ng/mL, 3.6% at 376 ng/mL, 3.6% at 417 ng/mL) |
| Reproducibility | Not explicitly stated as a separate acceptance criterion, but results imply meeting acceptable reproducibility for clinical use. | Example: Within-run CV 5.9% (0.34 ng/mL), Reproducibility CV 7.4% (0.34 ng/mL); Within-run CV 2.5% (402 ng/mL), Reproducibility CV 5.9% (402 ng/mL) |
| Linearity | Assay demonstrates linearity across the measuring interval. | Demonstrated linearity across the measuring interval. |
| Limit of Blank (LoB) | Not explicitly stated as a numerical criterion, but a low value is expected for accurate detection. | 0.03 ng/mL |
| Limit of Detection (LoD) | Not explicitly stated as a numerical criterion, but a low value is expected for accurate detection. | 0.05 ng/mL |
| Limit of Quantitation (LoQ) ≤20% within-lab CV | ≤ 0.1 ng/mL at 20% within-lab CV (explicitly stated criteria) | 0.1 ng/mL |
2. Sample sizes used for the test set and the data provenance
- Method Comparison: N = 187 samples. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Imprecision: For each sample, N = 88 or 80. Data provenance is not specified.
- Reproducibility: For each sample, N = 75. Data provenance is not specified.
- Linearity, LoB, LoD, LoQ: Sample sizes for specific points within the linearity study or number of samples for LoB/LoD/LoQ determinations are not explicitly given, but the studies were conducted using "multiple samples," "multiple reagent lots," and "multiple days." Data provenance is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a quantitative immunoassay for measuring thyroglobulin levels. The 'ground truth' for such a device is established by the analytical reference measurement procedures using a reference method or known concentrations, rather than expert consensus on diagnostic images or clinical assessments. Therefore, this question is not applicable in the context of this device.
4. Adjudication method for the test set
Not applicable for a quantitative immunoassay. The comparison is statistical analysis of measured values against a predicate device or expected values from reference materials.
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 not an AI/ML device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an automated immunoassay system. The performance studies ("Method Comparison," "Imprecision," "Reproducibility," "Linearity," "Detection Capability") represent the standalone performance of the assay and instrument without human interpretation of raw signals influencing the final quantitative result.
7. The type of ground truth used
For this immunoassay device, the "ground truth" implicitly refers to:
- Reference measurements from the predicate device (Access 2 Immunoassay System): Used for the method comparison study.
- Known concentrations/reference materials: Used to assess imprecision, linearity, and detection capabilities (LoB, LoD, LoQ) against expected values.
8. The sample size for the training set
Not applicable. This is a traditional diagnostic device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.