Alkaline Phosphatase
by Abbott Laboratories Diagnostics Division
510(k) K240468
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240468 | Date16 Oct 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
Overview
AI-generated summary, 1 Oct 2026
The Alkaline Phosphatase is an in vitro diagnostic device used for measuring alkaline phosphatase enzyme activity in serum or plasma samples. It falls under the category of biochemical analyzers and is designed to assist in the diagnosis and monitoring of conditions affecting bone metabolism, liver disease, and other clinical indications where elevated or altered enzyme levels may be relevant.
This device is intended for single-use in clinical chemistry laboratories and requires no sterilization beyond standard laboratory practices. It is classified as a Class II medical device under FDA regulations (21 CFR 862.1050) and received Special 510(k) clearance (K240468) on October 16, 2024. Supplied as a reagent for use with compatible automated or semi-automated biochemical analyzers, it is not intended for MRI use and must be stored according to manufacturer instructions to maintain stability and accuracy.
Other devices from Abbott Laboratories Diagnostics Division
Questions
AI-generated answers, 1 Oct 2026
What clinical conditions is the Alkaline Phosphatase reagent used to diagnose or monitor?
This reagent measures alkaline phosphatase enzyme activity in serum or plasma, aiding in the diagnosis and monitoring of conditions like bone metabolism disorders (e.g., Paget’s disease, rickets) and liver diseases (e.g., cholestasis, cirrhosis). Elevated or altered enzyme levels can indicate these conditions, making it a key tool for clinicians assessing organ function or metabolic health.
How is the Alkaline Phosphatase reagent supplied, and what equipment does it require?
The reagent is supplied as a single-use component designed exclusively for use with compatible automated or semi-automated biochemical analyzers in clinical chemistry laboratories. It is not a standalone device and must be paired with the appropriate analyzer system to perform measurements. The reagent is not intended for manual testing or use outside of these automated platforms.
Is the Alkaline Phosphatase reagent sterile, and what are the storage requirements?
The reagent is intended for single-use in clinical settings and does not require additional sterilization beyond standard laboratory practices. To maintain stability and accuracy, it must be stored according to the manufacturer’s instructions, which typically include protecting it from extreme temperatures, light exposure, and contamination. Always refer to the accompanying documentation for specific storage conditions.
Can the Alkaline Phosphatase reagent be reused, or is it designed for one-time use?
This reagent is explicitly designed for single-use only. Reusing it could compromise test accuracy, introduce contamination, or violate manufacturer guidelines, potentially leading to unreliable diagnostic results. Single-use ensures consistency and safety in clinical chemistry applications.
What regulatory pathway was followed for the Alkaline Phosphatase reagent’s clearance?
The reagent received Special 510(k) clearance (K240468) from the FDA on October 16, 2024, under the classification of a Class II medical device (21 CFR 862.1050). This pathway was used to demonstrate that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets safety and performance standards for clinical use in measuring alkaline phosphatase activity.