# K012518: Trace Scientific Alkaline Phosphatase, Two Part Liquid, Model TR-113

- Pathway: 510(k) (Abbreviated)
- Applicant: Thermo Dma, Inc.
- Decided: Oct 9, 2001 after 64 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) Roche Diagnostics Alkaline Phosphatase: named in the summary without a submission number

## Indications for use
This reagent is intended for the in vitro quantitative determination of Alkaline Phosphatase in human serum and plasma. Measurements of Alkaline Phosphatase or its isoenzymes are used as in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.

Source page: https://510kreport.com/device/K012518
Methodology: https://510kreport.com/methodology