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The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of PAP level in human serum to aid in the management and monitoring the effectiveness of various therapeutic treatments of prostate cancer patients. (for Professional use only)

The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA).

This document is a marketing authorization letter for the UBI MAGIWEL™ PAP EIA Quantitative device (K981573) from the FDA dated September 15, 1998. It states that the device is substantially equivalent to legally marketed predicate devices. The document also includes an "Indications for Use" statement. However, it does not contain any information regarding acceptance criteria, study details, or performance data of the device.

Therefore, I cannot provide the requested information based on the provided text. The document is solely an authorization letter and does not include the technical details of the device's performance or the studies conducted to support its claims.

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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).

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