PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

K964756 · Wano-Tech Corp. · JFH · Apr 23, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964756
• Device Name: PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
• Applicant: Wano-Tech Corp.
• Product Code: JFH · Clinical Chemistry
• Decision Date: Apr 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1020
• Device Class: Class 2

Device Story

In vitro diagnostic reagent test kit for measuring prostatic acid phosphatase (PAP) levels in human serum or plasma. Utilizes anti-human PAP mouse monoclonal antibodies to inhibit PAP activity, providing higher organ specificity than traditional tartaric acid inhibition methods. Employs high-sensitivity composite substrate 2,6-dichloro-4-acetylphenyl phosphate (DCAP-P). Designed for use on general-purpose automated analyzers in clinical laboratory settings. Provides quantitative results to assist clinicians in diagnosing and monitoring prostatic cancer patients. Replaces complex, time-consuming RIA and EIA methods with a faster, simpler procedure requiring less specialized equipment.

Clinical Evidence

No clinical data provided. Summary relies on established literature (Gutman et al., 1936; Fishman et al., 1963; Foti et al., 1976; Choe et al., 1979; Katayama et al., 1992) regarding the clinical utility of PAP as an index for prostatic cancer diagnosis and monitoring.

Technological Characteristics

In vitro diagnostic reagent kit. Key components: anti-human PAP mouse monoclonal antibodies; 2,6-dichloro-4-acetylphenyl phosphate (DCAP-P) substrate. Principle: Monoclonal antibody-mediated inhibition of PAP activity followed by enzymatic reaction with DCAP-P. Designed for integration with general-purpose automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of prostatic acid phosphatase (PAP) in human serum or plasma to aid in the diagnosis and monitoring of prostatic cancer.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Abbott PAP EIA test kit

Submission Summary (Full Text)

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WANO-TECH CORPORATION
260 Harbor Boulevard Belmont, CA 94002, U. S. A.
K96H736
Tel: [phone]
Fax: [phone]
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 system

This applications identifies the Abbott PAP EIA test kit as the legally marketed device to which we claim equivalence.

Since Gutman et al reported¹ 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 RIA³ 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

1. Gutman, E.B., et al. Am. J. Cancer 28:485-495, 1936
2. Fishman, W.H., et al. J. Biol. Chem. 200:89-97, 1963
3. Foti, A.G., et al. Cancer Research 35:2448-2452, 1976
4. Choe, B.K, et al. Proc. Soc. Exp. Biol. Med. 162:369-400, 1979
5. Katayama, K. et al. Clin. Chem. 38:979, 1992

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