Abbott Clinical Chemistry Reagent Alkaline Phosphatase (ALP)
by Abbott Laboratories 510(k)
Active
510(k) K890521
Overview
This device is a Clinical Chemistry Reagent for Alkaline Phosphatase (ALP) and its isoenzymes, classified under the FDA’s Nitrophenylphosphate category. It is designed for use in automated clinical chemistry analyzers to measure ALP activity in serum or plasma samples, aiding in the diagnosis and monitoring of bone disorders, liver disease, and other metabolic conditions. The reagent facilitates enzymatic reactions that produce a measurable colorimetric change, enabling quantitative analysis of ALP levels.
The reagent is supplied as a liquid for use with compatible clinical chemistry analyzers, including those listed under the FDA K890521 clearance. It is intended for single-use in laboratory settings and requires adherence to standard laboratory protocols for handling and storage. The device is regulated under FDA 510(k) clearance (K890521) and falls under Class II medical devices (FDA device class 2). No specific sterility or MRI safety information is provided, and compliance with FDA regulation 862.1050 applies. Storage conditions and expiration dates are manufacturer-specified and must be followed as per labeling instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890521 | Date24 Mar 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Abbott Clinical Chemistry Reagent Alp
- 510(k) Number
- FDA Product Code
- CJE
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1050
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Abbott Clinical Chemistry Reagent ALP used for?
The Abbott Clinical Chemistry Reagent ALP is designed for use in automated clinical chemistry analyzers to measure Alkaline Phosphatase (ALP) activity and its isoenzymes in serum or plasma samples. ALP levels are critical for diagnosing and monitoring conditions such as bone disorders (e.g., metabolic bone disease, Paget’s disease), liver disease (e.g., cholestasis, cirrhosis), and other metabolic conditions. The reagent facilitates an enzymatic reaction that produces a measurable colorimetric change, enabling precise quantitative analysis of ALP levels.
How is the Abbott Clinical Chemistry Reagent ALP supplied and intended for use?
This reagent is supplied as a liquid formulation specifically for use with compatible automated clinical chemistry analyzers. It is intended for single-use in laboratory settings, adhering to standard laboratory protocols for handling and storage. The reagent is not designed for reuse or repeated use beyond its intended single application per vial or container.
Is sterility or MRI safety information provided for this reagent?
The provided documentation does not specify any details regarding sterility or MRI safety for the Abbott Clinical Chemistry Reagent ALP. Users should follow the manufacturer’s labeling instructions and local regulatory guidelines for handling and storage, particularly if sterility or MRI compatibility are concerns in their workflow.
What storage conditions and expiration dates apply to this reagent?
Storage conditions and expiration dates for the Abbott Clinical Chemistry Reagent ALP are manufacturer-specified and must be strictly followed as outlined on the labeling. These details typically include temperature ranges (e.g., refrigerated or room temperature), protection from light, and shelf-life validity. Always verify the expiration date before use to ensure accuracy and reliability of results.
Which clinical chemistry analyzers are compatible with this reagent?
The Abbott Clinical Chemistry Reagent ALP is compatible with automated clinical chemistry analyzers listed under the FDA clearance K890521. While the exact models are not explicitly enumerated in the provided data, the reagent is designed for use with systems that support the Nitrophenylphosphate reaction method for ALP measurement. For precise compatibility, refer to the manufacturer’s instructions or contact Abbott Laboratories for a full list of supported analyzers.