# K981245: Alkaline Phosphatase (Alkp)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 20, 1998 after 44 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: 1 generation back to K902560 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902560: Roche Cobas Ready Alkaline Phosphatase Reagent, Roche Diagnostic Systems, Inc. (1990) Summary page 1.

## 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/K981245
Methodology: https://510kreport.com/methodology