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510(k) Data Aggregation
(52 days)
ABBOTT ARCHITECT TOTAL T3
The ARCHITECT™ Total T3 (TT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The ARCHITECT Total T, assay is to be used as an aid in the assessment of thyroid status.
ARCHITECT Total T2 is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Total T, is calibrated with ARCHITECT Total T. Calibrators. ARCHITECT Total T2 Controls are assayed for verification of the accuracy and precision of the Abbott ARCHITECT i System.
This 510(k) submission pertains to the Abbott ARCHITECT™ Total T3 assay, a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The study conducted aimed to demonstrate substantial equivalence to a legally marketed predicate device, the AxSYM® Total T3 assay.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for correlation, slope, or intercept. Instead, it presents the results of the comparison study to demonstrate substantial equivalence to the predicate device. The performance is reported in comparison to the AxSYM Total T3 assay.
| Metric | Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance (ARCHITECT Total T3 vs. AxSYM Total T3) |
|---|---|---|
| Correlation Coefficient (Least Squares) | Expected high correlation (implied from goal of substantial equivalence) | 0.950 |
| Slope (Least Squares) | Expected close to 1 (implied from goal of substantial equivalence) | 0.86 |
| Y-axis Intercept (Least Squares) | Expected close to 0 ng/mL (implied from goal of substantial equivalence) | 0.22 ng/mL |
| Correlation Coefficient (Passing-Bablok) | Expected high correlation (implied from goal of substantial equivalence) | 0.950 |
| Slope (Passing-Bablok) | Expected close to 1 (implied from goal of substantial equivalence) | 1.08 |
| Y-axis Intercept (Passing-Bablok) | Expected close to 0 ng/mL (implied from goal of substantial equivalence) | -0.04 ng/mL |
Note: The acceptance criteria are implicitly derived from the objective of showing substantial equivalence to the predicate device, meaning the new device should perform very similarly to the predicate.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: 1120 specimens
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
This type of in vitro diagnostic device (IVD) submission typically relies on a comparator method (the predicate device) as the reference for "ground truth" or a well-established clinical assay. There is no mention of human experts being used to establish ground truth for individual test cases in the context of this 510(k) submission.
4. Adjudication Method for Test Set
Not applicable. The ground truth was established by comparison to a predicate device, not by expert interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging devices where human readers interpret medical images. This submission is for an in vitro diagnostic assay.
6. Standalone Performance Study
Yes, a standalone performance study was done for the ARCHITECT Total T3 assay in the sense that its performance was assessed independently by comparing its results against a predicate device. This is a common approach for IVDs to demonstrate performance for regulatory clearance. The "algorithm only" in this context refers to the assay's performance itself, independent of human interpretation of the results.
7. Type of Ground Truth Used
The "ground truth" for the test set was essentially the results obtained from the AxSYM® Total T3 assay, which is the legally marketed predicate device. The study aimed to show strong agreement between the new device and this established method.
8. Sample Size for Training Set
The document does not specify a separate "training set" or its sample size. For an IVD like this, the development and optimization of the assay would typically involve extensive internal testing during the R&D phase, but this information is usually not detailed in the 510(k) summary, which focuses on validation data. The 1120 specimens mentioned are for the comparison study, effectively acting as the validation or test set against the predicate.
9. How Ground Truth for Training Set Was Established
As there is no explicit mention of a separate training set in the context of the 510(k) summary, how its "ground truth" was established is not provided. If a training phase existed for the assay's development, it would likely involve comparisons to reference methods or clinically validated samples during the assay optimization process.
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