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Clinical laboratories, performing quantitative or semi-quantitative tests to determine alpha fetoprotein (AFP) in patient specimen and desiring to use the quality control material that is not provided with the kit used for such measurement, may use Qualitrol AFP Control Set as an alternative. Compattibility among the test reagents and Qualitrol AFP Control Set needs to be established prior to such a use.

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This document is an FDA 510(k) clearance letter for a quality control material, the "Qualitrol, Alpha Fetoprotein (AFP) Control Set."

Such documents do not typically include details about acceptance criteria, device performance studies, or ground truth establishment in the way requested for AI/machine learning devices. This 510(k) is for an in-vitro diagnostic quality control product, not a device that directly analyzes patient data to provide a diagnosis or prediction.

Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) cannot be extracted from this document.

The document primarily focuses on:

• Confirming substantial equivalence to a predicate device.
• Listing regulatory information (regulation number, product code, regulatory class).
• Providing general FDA compliance requirements for the manufacturer.
• Stating the intended use of the device.

To answer your questions for this type of product, one would need to consult the original 510(k) submission summary or technical file, which would detail the analytical performance studies demonstrating the control material's stability, homogeneity, and assigned values, rather than clinical performance against a disease state.

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