(27 days)
The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment og thyroid diseases such as hyperthyroidism.
The DSL ACTIVE™ T3 RIA kit was developed for the quantitative measurement of Total T3 in human serum. The RIA format is a competitive binding protein assay. Radiolabeled T3 competes with un-labeled T3 in the serum sample for binding sites to the antibody. Separation of free from bound T3 is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the sample.
The provided text is a summary of safety and effectiveness for a diagnostic device, the DSL 3100 ACTIVE™ T3 RIA Kit. It describes the device's purpose, mechanism, and states its substantial equivalence to another device, the DPC COAT-A-COUNT TOTAL T3 RIA.
However, the text does not contain any information about acceptance criteria, a study proving device adherence to these criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
The only "study" mentioned is a comparison study to demonstrate substantial equivalence, which is described as follows:
Comparison Study Information (from the provided text):
- Objective: To demonstrate substantial equivalence between the DSL ACTIVE™ T3 RIA and the DPC COAT-A-COUNT TOTAL T3 RIA.
- Sample Size: n=30 patient samples.
- Sample Selection: Samples were chosen based on expected T3 levels (low, intermediate, and high).
- Method: Assayed using both methods.
- Results: Linear regression analysis yielded the equation Y = 1.09(X) + -8.8 with a correlation coefficient (r) = 0.90. (Where Y is likely the DSL ACTIVE™ T3 RIA result and X is the DPC COAT-A-COUNT TOTAL T3 RIA result, although this is not explicitly stated).
Based on the provided text, I cannot complete the requested table and information, as it is largely absent from the document. The document focuses on regulatory submission details and a short equivalence study, not detailed performance criteria or AI-specific development.
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Diagnostic Systems Laboratories, Inc 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220
Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 3100 ACTIVE™ T3 RIA Kit Name of Device: Classification Name: Radioimmunoassay, Triiodothyronine Analyte Code and Name: Total Triiodothyronine Regulatory Class:
Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678
February 7, 1996 Date:
The DSL ACTIVE™ T3 RIA kit was developed for the quantitative measurement of Total T3 in human serum. The RIA format is a competitive binding protein assay. Radiolabeled T3 competes with un-labeled T3 in the serum sample for binding sites to the antibody. Separation of free from bound T3 is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the sample.
The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment og thyroid diseases such as hyperthyroidism.
The DSL ACTIVE™ T3 RIA is substantially equivalent to the DPC COAT-A-COUNT TOTAL T3 RIA.
To demonstrate substantial equivalence between the two assays, patient samples (n=30) were collected and assayed using both methods. Samples were chosen based on expected T3 levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y = 1.09(X) + -8.8 with a correlation coefficient of (r) = 0.90.
§ 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.