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The BioCheck TSH ElA is intended for the quantitative determination of thyrotropin, or thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.

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The provided text is an FDA 510(k) clearance letter for the BioCheck TSH EIA test kit. It acknowledges the device's substantial equivalence to a predicate device and permits its marketing.

Unfortunately, the document does not contain the detailed study information required to answer the questions about acceptance criteria and device performance.

The letter primarily focuses on regulatory approval, referencing an "Indications for Use Statement" and general compliance with FDA regulations. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.
• Sample size or ground truth establishment for a training set.

To obtain this information, one would typically need to consult the full 510(k) submission (which is often publicly available through FDA databases but not provided in this excerpt) or the device's official documentation (e.g., package insert, manual).

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