Spinchem Acid Phosphatase Reagent
by Smithkline Diagnostics, Inc. 510(k)
Active
510(k) K821674
Overview
The Spinchem Acid Phosphatase Reagent is a diagnostic reagent used for measuring acid phosphatase activity in clinical chemistry. Acid phosphatase is an enzyme whose elevated levels can indicate conditions such as prostate cancer, bone disorders, or other metabolic diseases. This reagent is designed for use in automated clinical chemistry analyzers to provide quantitative results in serum or plasma samples.
This reagent is supplied as a liquid for in vitro diagnostic use and is intended for single-use applications in clinical laboratories. It is classified as a Class II device under FDA regulations and has received a 510(k) clearance (K821674) as substantially equivalent to a predicate device. The product is distributed in sterile or non-sterile forms depending on the specific lot and must be stored according to manufacturer instructions to maintain stability and accuracy. No MRI safety information is specified, and the device is regulated under FDA product code CKB.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821674 | Date22 Jun 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1020
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Smithkline Diagnostics, Inc.
Questions
What is the Spinchem Acid Phosphatase Reagent used for?
The Spinchem Acid Phosphatase Reagent is designed for measuring acid phosphatase activity in clinical chemistry. Elevated levels of this enzyme can indicate potential conditions such as prostate cancer, bone disorders, or other metabolic diseases. It provides quantitative results when used with automated clinical chemistry analyzers on serum or plasma samples, helping clinicians assess patient health.
How is the Spinchem Acid Phosphatase Reagent supplied?
This reagent is supplied as a liquid for in vitro diagnostic use. It is intended for single-use applications in clinical laboratories, ensuring accuracy and consistency for each test run. The liquid form allows for easy integration into automated systems.
Is the Spinchem Acid Phosphatase Reagent sterile?
The sterility of the Spinchem Acid Phosphatase Reagent depends on the specific lot. Some lots may be sterile, while others may be non-sterile. Always refer to the manufacturer’s instructions or labeling for the sterility status of your particular lot to ensure proper handling and compliance with laboratory protocols.
Can the Spinchem Acid Phosphatase Reagent be reused?
No, the Spinchem Acid Phosphatase Reagent is intended for single-use applications only. Reusing the reagent could compromise test accuracy and introduce contamination risks, potentially leading to unreliable diagnostic results. Always follow the manufacturer’s guidelines for proper usage.
How should the Spinchem Acid Phosphatase Reagent be stored?
The Spinchem Acid Phosphatase Reagent must be stored according to the manufacturer’s instructions to maintain its stability and accuracy. Proper storage conditions typically include protecting it from extreme temperatures, light exposure, and contamination. Always check the labeling or accompanying documentation for specific storage recommendations.