(147 days)
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This method uses anti-human PAP mouse monoclonal antibodies to inhibit PAP activity which results in much higher specificity than is obtained with tartaric acid inhibition method. With this test kit, the PAP is completely eliminated from ACP in calculating the level of PAP. High sensitivity composite substrate 2,6-doichloro-4-acetylphenyl phosphate (DCAP-P) is used, making it simple and fast to use with general purpose automated analyzers.
The provided text is a 510(k) summary for a Prostatic Acid Phosphatase Reagent Test, focusing on its equivalence to existing methods and the scientific background of PAP testing. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the requested questions about a modern AI/ML medical device submission.
Therefore, I cannot provide the requested table and details based on the given input text. The input discusses a traditional in-vitro diagnostic (IVD) assay from 1997, not an AI/ML-based device that would typically involve the types of studies and criteria mentioned in the prompt (e.g., test sets, training sets, human readers, adjudication, MRMC studies).
§ 862.1020 Acid phosphatase (total or prostatic) test system.
(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.