(147 days)
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No
The device description focuses on a biochemical assay method using antibodies and a specific substrate, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is described as a test kit that uses antibodies and a substrate to measure PAP levels, indicating it is an in-vitro diagnostic (IVD) device for diagnostic purposes, not for treating a condition.
Yes
This device is a test kit designed to measure prostatic acid phosphatase (PAP) levels, which is a common diagnostic marker for prostate conditions. The description explicitly states it "completely eliminated from ACP in calculating the level of PAP," indicating its role in providing quantitative diagnostic information.
No
The device description clearly describes a test kit utilizing antibodies and a chemical substrate, indicating a hardware-based diagnostic test, not a software-only device.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Method Description: The description details a method for measuring Prostatic Acid Phosphatase (PAP) activity using antibodies and a substrate. This is a laboratory test performed on biological samples (likely blood or serum, although not explicitly stated).
- Target Analyte: It measures PAP, which is a biomarker found in the body.
- Comparison to Reference Device: The mention of a "Reference Device(s)" which is an "Abbott PAP EIA test kit" strongly suggests that this device is also a test kit designed for laboratory use to measure PAP. EIA (Enzyme Immunoassay) is a common IVD technique.
- Use with Automated Analyzers: The statement "making it simple and fast to use with general purpose automated analyzers" indicates it's designed for use in a clinical laboratory setting.
While the "Intended Use / Indications for Use" section is missing, the technical description of the method and its comparison to a known IVD test kit (Abbott PAP EIA) strongly point towards it being an in vitro diagnostic device used to measure PAP levels in biological samples.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
prostatic
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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.