# K980316: Alkaline Phosphatase-SL Assay Catalogue Number 309-10, 309-30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Feb 12, 1998 after 16 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For the quantitative determination of Alkaline Phosphatase in serum. For IN VITRO diagnostic use. Elevated alkaline phosphatase activity in serum is of interest in the diagnosis of several general disease conditions including hepatobiliary disease and bone disease associated with increased osteoblastic activity. Alkaline phosphatase activity in serum may be elevated due to obstructive jaundice, occlusion of the common bile or hepatic duct, and cirrhosis. (1) Alkaline phosphatase (AP) activity was first measured by Kay (2). Since that time many substrates such as glycerol phosphate and phenyl phosphate have been used. Bessey, Lowry, and Brock (3) introduced a more sensitive substrate p-nitrophenyl phosphate (p-NPP). Several recommendations have been made on the optimum conditions for the determination of AP in serum. These suggestions have been put forth by the German Society for Clinical Chemistry (4) as well as by the committee on enzymes of the Scandinavian Society for Clinical Chemistry (5). This method is in accordance with the recommendations of the International Federation of Clinical Chemistry (IFCC) for AP measurement in serum (6).

Source page: https://510kreport.com/device/K980316
Methodology: https://510kreport.com/methodology