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The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in serum and plasma. For In Vitro Diagnostic Use.

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This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain any information about acceptance criteria or specific study results.

The letter confirms that the STC Cotinine Micro-Plate EIA (Serum and Plasma) device is substantially equivalent to legally marketed predicate devices. However, it does not detail the studies performed to demonstrate this equivalence or the performance characteristics required for clearance.

Therefore, I cannot provide the requested information from this document. It lacks details regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

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The provided document is a 510(k) clearance letter for the "STC Cotinine Micro-Plate EIA" device. It does not contain the detailed study information required to answer all parts of your request. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for test and training sets.
• Information on MRMC studies or standalone algorithm performance.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the device (K974234).
• The regulatory classification (Class II, Product Code MKU).
• General controls and applicable regulations.
• The intended use of the device.

Therefore, I cannot provide a complete answer to your request based solely on the provided text. I can, however, extract the Indications for Use as this is the only performance-related information explicitly stated:

Indications For Use: The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

To answer your request thoroughly, I would need access to the actual 510(k) submission document (K974234) which details the validation studies conducted for the device.

Ask a specific question about this device