# K991387: Elan Alkaline Phosphate Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Elan Holdings, Inc.
- Decided: May 19, 1999 after 28 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. The FDA summary names its predicate without a number.
- (no number) Beckman® SYNCHRON® Systems ALP Reagent, product no. 442670: named in the summary without a submission number

## Indications for use
Elan ALP Reagent is intended for the quantitative determination of alkaline phosphatase in serum and plasma for the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This reagent is intended to be used on a Beckman® SYNCHRON CX® autoanalyzer in a professional setting or by trained personnel, and is not intended for home use.

Source page: https://510kreport.com/device/K991387
Methodology: https://510kreport.com/methodology