(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).
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WANO-TECH CORPORATION
260 Harbor Boulevard Belmont, CA 94002, U. S. A.
Tel: (415) 802-7030 Fax: (415) 802-7042
APR
23 1997
510(k) Summary
- Trade name: Prostatic Acid Phosphatase Reagent Test .
- Common name: PAP test kit ●
- Classification name: CFR 862.1020 Acid phosphatase (total or prostatic) . test svstem
This applications identifies the Abbott PAP EIA test kit as the legally marketed device to which we claim equivalence.
Since Gutman et al reproted! in 1936 that abnormally high levels of acid phosphatase (ACP) and partially, prostatic acid phosphatase (PAP), were found in prostatic cancer patients, ACP and PAP have been used as indexes in the diagnosis and monitoring of prostatic cancer.
Previously, L- (+) tartaric acid inhibition method was used to determine the level of PAP2; however , it has been known to inhibit ACP of other origins. Thus sufficient sensitivity and organ specificity were not achieved until the development of RIA® and EIA4 methods. Despite their accuracy, RIA and EIA require a substantial amount of time to administer and are intricate to perform. Other problems with these methods include the prerequisite of specialized equipment.
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 analyzers5.
BIBLIOGRAPHY
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- Gutman, E.B., et al. Am. J. Cancer 28:485-495, 1936
- Fishman, W.H., et al. J. Biol. Chem. 200:89-97, 1963 2.
- Foti, A.G. , et al. Cancer Research 35:2448-2452, 1976 3.
- Choe, B.K. et al. Proc. Soc. Exp. Biol. Med. 162:369-400, 1979 4.
- Katayama, K. et al. Clin. Chem. 38:979, 1992 5.
§ 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.