Modification to Alkaline Phosphatase
by Abbott Laboratories 510(k)
Active
510(k) K023807
Overview
The Modification to Alkaline Phosphatase is a diagnostic device classified as Nitrophenylphosphate, Alkaline Phosphatase or Isoenzymes, per FDA nomenclature. It measures alkaline phosphatase or its isoenzymes in serum or plasma to aid in the diagnosis and monitoring of liver, bone, parathyroid, and intestinal conditions. The device employs nitrophenylphosphate substrates to detect enzyme activity, facilitating clinical assessments of metabolic and organ-related disorders.
This device is supplied as a modification to existing alkaline phosphatase test systems and is intended for in vitro diagnostic use in clinical chemistry laboratories. It is regulated under FDA regulation 862.1050 and falls under Device Class II with a 510(k) clearance (K023807) for substantial equivalence. The modification does not alter sterility or single-use/reusable status, as these are determined by the parent test system’s specifications. Storage and handling comply with standard in vitro diagnostic protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023807 | Date26 Dec 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Modification to Alkp
- 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 clinical conditions does this modification help diagnose or monitor?
This modification to the alkaline phosphatase test system measures alkaline phosphatase or its isoenzymes in serum or plasma. It aids in diagnosing and monitoring metabolic and organ-related disorders, including liver, bone, parathyroid, and intestinal conditions. The nitrophenylphosphate substrates detect enzyme activity, providing critical insights for clinical assessments.
How is this modification supplied and how does it integrate with existing systems?
The Modification to Alkaline Phosphatase is designed as an add-on to existing alkaline phosphatase test systems. It is not a standalone device but enhances the functionality of compatible systems to measure alkaline phosphatase or isoenzymes. The modification does not alter sterility or single-use/reusable status—those specifications remain determined by the parent test system’s design.
Is this modification single-use or reusable, and what are the storage requirements?
The single-use or reusable status of this modification depends entirely on the specifications of the parent test system it is integrated with. Abbott does not alter these attributes. Storage and handling must comply with the standard protocols for in vitro diagnostic devices, ensuring proper conditions for the parent system’s reagents and components.
What regulatory pathway does this modification follow, and what class is it assigned?
This modification was cleared by the FDA under a 510(k) pathway (K023807) as substantially equivalent to a predicate device. It falls under Device Class II and is regulated under FDA regulation 862.1050. The clearance was granted by the Clinical Chemistry (CH) Advisory Committee, confirming its compliance with in vitro diagnostic standards.
Are there specific model or reference numbers associated with this modification?
While this modification is not assigned a standalone model or reference number, it is compatible with multiple existing alkaline phosphatase test systems, each identified by unique registration numbers (e.g., 8040374, 8020316) and FEI numbers (e.g., 3016438761). These identifiers correspond to the parent systems it enhances, ensuring proper integration and functionality.