(41 days)
The quantitative determination of thyrotropin (TSH) concentration in human serum by a microplate enzymeimmunoassay.Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an enzymeimmunoassay (IEMA) kit for the determination of thyrotropin (TSH) In human serum. The proprietary name is Thyrotropin (TSH) ELISA and the usual name is TSH IEMA. This device classification name is - thyroid-stimulating hormone test system - product code JLW (per 21 CRF section 862.1690). The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-biotin reaction to effect separation. Upon mixing monoclonal biotinylated anti-TSH antibody, the enzyme-labeled anti-TSH antibody and a serum containing the native antigen (TSH), reaction results between the native antigen (TSH) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well is directly proportional to the native antigen (TSH) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.
Here's a breakdown of the acceptance criteria and study information for the Monobind Thyrotropin (TSH) ELISA, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Method Agreement (Correlation Coefficient) | 0.995 (between Monobind ELISA and predicate device) This indicates a very high degree of correlation, suggesting strong agreement between the two methods. |
| Linear Equation (Slope and Intercept) | y = 0.47 + 0.968x (between Monobind ELISA and predicate device) The slope (0.968) is very close to 1 and the intercept (0.47) is very close to 0, further indicating strong agreement. |
| Recovery Data | 98.1% average recovery when exogenous TSH was added to human serum specimens.**This suggests the device accurately measures TSH even when present at different concentrations. |
| Linearity Studies | 99.2% average when specimens were diluted and compared to the dose response curve. This demonstrates the device's ability to provide proportional results across a range of concentrations. |
Study Details:
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 170 specimens.
- Data Provenance: The specimens were obtained from "hypothyroid, euthyroid and hyperthyroid populations," implying human clinical samples. The text does not explicitly state the country of origin or if the study was retrospective or prospective.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document describes a "clinical comparison (linear regression)" against a predicate device (Ciba Corning ACS 180 chemiluminescence (ICMA) test), which is itself an established method for TSH determination. Therefore, the "ground truth" for the test set was essentially the results obtained from the predicate device, not established by human experts in this context.
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Adjudication Method for the Test Set:
- Not applicable. The comparison was statistical (linear regression) against a predicate device, not an expert-based adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not described. This study focused on the performance of the new device compared to an existing device, not on human reader performance with or without AI assistance.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, this was a standalone study of the device (Thyrotropin (TSH) ELISA) itself. Its performance was directly compared to the predicate device.
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Type of Ground Truth Used:
- Predicate Device Results: The results obtained from the Ciba Corning ACS 180 chemiluminescence (ICMA) test served as the reference or "ground truth" for comparison.
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Sample Size for the Training Set:
- The document implies that the "training" in this context refers to the development and calibration of the ELISA kit itself, including the generation of a dose-response curve using "several different serum references of known antigen values." It does not specify a distinct "training set" sample size in the same way a machine learning algorithm might.
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How the Ground Truth for the Training Set Was Established:
- The ground truth for generating the dose-response curve (calibration) for the Monobind ELISA was established by using "several different serum references of known antigen values." These known values would typically be traceable to international standards for TSH.
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.