(36 days)
for the quantitative determination of free Ts in human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA).
AxSYM Free T2 is a microparticle enzyme immunoassay for the quantitative determination of free Ts in human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA). AxSYM Free T3 is calibrated with Abbott calibrators. Abbott controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
This 510(k) summary describes a new in-vitro diagnostic device, the Abbott AxSYM Free T3, and compares it to a legally marketed predicate device, the Ciba Corning Automated Chemiluminescence System (ACS) Free T3 Immunoassay. The document focuses on demonstrating substantial equivalence rather than establishing specific performance acceptance criteria for a de novo device.
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) are not explicitly stated as they would be for a de novo device. Instead, the "acceptance criterion" is successful correlation with the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance (AxSYM Free T3 vs. ACS Free T3) |
|---|---|
| Strong correlation with predicate device | Correlation Coefficient: 0.948 |
| Acceptable linear relationship with predicate device | Slope: 1.19 |
| Low variability around the regression line | Standard Error of Estimate: 0.775 |
| Acceptable intercept value | Y-axis Intercept: -0.96 pg/mL |
| Comparable intended use | Both for quantitative determination of free T3 |
| Comparable analytical range (within clinical utility) | AxSYM Free T3 Dynamic Range: 1.1 - 30.0 pg/mL |
| ACS Free T3 Dynamic Range: 0.5 - 20.0 pg/mL | |
| Comparable sample types | AxSYM Free T3: Human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA) |
| ACS Free T3: Human serum only |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 745 specimens
- Data Provenance: Not explicitly stated. Given the context of a 510(k) summary for a clinical diagnostic, these would typically be human serum/plasma samples, but the country of origin and whether they were retrospective or prospective are not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable (N/A). For this type of in-vitro diagnostic comparison, ground truth is typically assessed against the performance of a well-established and legally marketed predicate device, not by expert consensus on individual case diagnoses. The "ground truth" for the comparison is the reading from the predicate ACS Free T3 assay.
4. Adjudication Method for the Test Set
- Not applicable (N/A). No adjudication method is described, as the comparison is between two quantitative assays, where values are directly measured and correlated rather than requiring expert interpretation and consensus on diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is an in-vitro diagnostic device comparison, not a study involving human readers interpreting images or data. Therefore, an MRMC study and effects of AI assistance are not relevant here.
6. Standalone (Algorithm Only) Performance Study
- Yes, in the context of an IVD. The "standalone performance" is implicitly demonstrated through the correlation analysis of the AxSYM Free T3 assay when compared to the predicate ACS Free T3 assay using the 745 specimens. The device, in this case, is the assay system itself, and its performance is evaluated directly without human interpretation influencing the quantitative result.
7. Type of Ground Truth Used
- Comparative Ground Truth (Predicate Device Measurement). The "ground truth" for this study is the quantitative Free T3 value obtained from the legally marketed and established Ciba Corning Automated Chemiluminescence System (ACS) Free T3 Immunoassay. This is a common approach for 510(k) submissions demonstrating substantial equivalence.
8. Sample Size for the Training Set
- Not explicitly stated. The document describes a comparison study, not the development or training of an algorithm in the machine learning sense. For an immunoassay, the "training" involves assay development, reagent optimization, and calibration. The specifics of the samples used for these internal development phases are not typically detailed in a 510(k) summary. The 745 specimens are for the validation/comparison study, not a training set.
9. How the Ground Truth for the Training Set Was Established
- Not explicitly stated. As above, the concept of a "training set" with established ground truth as understood in AI/ML is not directly applicable here. For an immunoassay, the "ground truth" for calibration and optimization would be based on reference materials, established laboratory methods, and known concentrations, but the details are not provided.
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510(k) Summary Abbott AxSYM Free T3
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification for AxSYM® Free T3 constitutes data supporting a substantially equivalent determination.
AxSYM Free T2 is a microparticle enzyme immunoassay for the quantitative determination of free Ts in human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA). AxSYM Free T3 is calibrated with Abbott calibrators. Abbott controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
Substantial equivalence has been demonstrated between the Abbott AxSYM Free Ts assay and the Ciba Corning Automated Chemiluminescence System (ACS) Free T3 Immunoassay. The intended use of both assays is for the quantitative determination of free T3. AxSYM Free T3 can be performed with human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA). However, ACS Free T3 can be performed on human serum only. A correlation analysis between these two assays, using 745 specimens, vielded a correlation coefficient of 0.948, slope of 1.19, standard error of estimate of 0.775, and Y-axis intercept of -0.96 pg/mL. The AxSYM Free T3 assay has a dynamic range of 1.1- 30.0 pg/mL, whereas the ACS Free T3 assay has a dynamic range of 0.5- 20.0 pg/mL.
In conclusion, these data demonstrate that the AxSYM Free T3 assay is safe and effective, and is substantially equivalent to the Ciba Corning Automated Chemiluminescence System (ACS) Free T3 Immunoassay.
Prepared and Submitted September 20, 1996 by:
Abbott Laboratories Laura Granitz Senior Regulatory Specialist ADD Regulatory Affairs Abbott Park, IL 60064
AxSYM Free T3 510(k) September 1996 aft3510k.hwp
Attachment A Page 1 of 1
§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.