# K990024: Careside Alkaline Phosphatase

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Jan 13, 1999 after 8 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 K912844 (1991). 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure alkaline phosphatase from anticoagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with diseases of the liver, pancreas, bone, parathyroid, and intestines.

Source page: https://510kreport.com/device/K990024
Methodology: https://510kreport.com/methodology