(50 days)
Biomerica's T3 microwell EIA is Enzyme Immuno-assay test for the quantitative determination of Triodothyronine (T3 ) in human serum.
Biomerica's T3 EIA is a sensitive solid phase enzyme immunoassay system for the quantitative determination of T3 in patient serum or plasma. Specific antibodies to T3 are immobilized on the inside surface of microwells of microtiter plate (96). A known volume of serum or plasma containing T3 and an enzyme labeled T3 conjugate are added to the antibody coated microwells. Both the T3 in the sample and the enzyme conjugated T3 compete for a limited number of binding sites available on the antibody. The unbound T3-enzyme conjugate is washed off from the microwells. A chromogen substrate mixture is added to the bound T3 enzyme conjugate to develop color. The intensity of the color developed is measure by the microtiter reader and is inversely proportional to the amount of T3 present in the patient's sample. The quantity of T3 present in the patient's sample (serum or plasma) is measured by extrapolating from the dose response curve (DRC) .
The provided text describes an in vitro diagnostic test kit, Biomerica's T3 microwell EIA, for the quantitative determination of Triodothyronine (T3) in human serum. However, it does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and study design for proving device performance.
The document is a 510(K) Summary Statement, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical study report with performance metrics, ground truth establishment, or sample sizes.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance (Table 1): The document states that the device is "substantially equivalent to T3 Coat-a- Count RIA test ( DPC kit )" and that "performance data and clinical data is on file." It does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or the reported performance metrics of the Biomerica T3 EIA against those criteria.
- Sample size for the test set and data provenance: Not mentioned.
- Number of experts and their qualifications for ground truth: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is not applicable to an in vitro diagnostic assay. MRMC studies are typically used for imaging AI systems where human readers interpret images.
- Standalone (algorithm-only) performance: Not explicitly stated in terms of specific metrics, though the device is a standalone test kit. The performance would be in terms of its ability to quantitate T3.
- Type of ground truth used: Not explicitly stated, though for an immunoassay, the "ground truth" would generally be established by a reference method or validated calibrators and controls.
- Sample size for the training set: Not applicable, as this is an immunoassay kit, not a machine learning algorithm that requires a "training set" in the conventional AI sense. The development of the assay involves optimizing reagents and conditions, but not "training" on a dataset.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided document is a high-level regulatory summary and lacks the granular technical and study design details needed to fill out your request. To obtain this information, one would need to access the full 510(K) submission, which is referenced as "on file and is available to any qualified individual upon request."
§ 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.