# K023807: Modification to Alkp

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Dec 26, 2002 after 42 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K823213 (1982). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981806: ALKP, Abbott Laboratories (1998) Summary page 1.

## Most influential descendants
- K240468: Alkaline Phosphatase (2024), 0 descendants of its own
- K223317: Alkaline Phosphatase2 (2023), 0 descendants of its own

## Indications for use
The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Source page: https://510kreport.com/device/K023807
Methodology: https://510kreport.com/methodology