(54 days)
The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.
The Randox Specific Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.
I am sorry, but the provided text from the FDA letter (K972608) refers to a RANDOX Assayed Specific Protein Control, which is a control material used for clinical chemistry applications. It is not a medical device that uses AI or requires the extensive studies (like MRMC, standalone performance, training sets, etc.) typically associated with AI-powered devices.
The document is an FDA clearance letter stating that the device is "substantially equivalent" to previously marketed devices. It does not contain information on:
- Acceptance criteria and reported device performance in the context of an AI study.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used (pathology, outcomes data, etc.).
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request for details about acceptance criteria and studies using AI, as this information is not present in the provided document, which pertains to a different type of medical product.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.