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The STC Auto-Lyte® Cotinine EIA is a homogeneous immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine. Cotinine is the major metabolite of nicotine, and the STC kit is useful in the detection of cotinine after ingestion of or exposure to nicotine. For In Vitro Diagnostic Use.

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I am sorry, but the provided text does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that you are requesting. The document is an FDA 510(k) clearance letter for the STC Auto-Lyte® Cotinine EIA, indicating that it has been found substantially equivalent to a predicate device.

It specifies:

• Device Name: STC Auto-Lyte® Cotinine EIA
• Indications For Use: Homogeneous immunoassay for qualitative and semiquantitative analysis of cotinine in human urine, useful in detecting cotinine after nicotine ingestion or exposure. For In Vitro Diagnostic Use.
• Regulatory Class: II

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication method for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
4. Stand-alone algorithm performance.
5. Type of ground truth used.
6. Sample size for the training set.
7. How ground truth for the training set was established.

This document is a regulatory approval, not a performance study report. To find the information you are looking for, you would typically need to refer to the 510(k) submission itself or related study publications if they exist.

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