# K130141: S Test Reagent Cartridge Alp (Alkaline Phosphatase)

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: Mar 22, 2013 after 59 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: 3 generations back to K953239 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100853: Cobas 8000 Modular Series Analyzer, Roche Diagnostics Corp. (2010) Summary page 3.

## Indications for use
The S TEST Reagent Cartridge Alkaline Phosphatase (ALP) is intended for the quantitative measurement of alkaline phosphatase activity in serum, lithium heparinized plasma, or sodium citrate plasma using the HITACHI Clinical Analyzer. The S TEST Reagent Cartridge Alkaline Phosphatase (ALP) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Source page: https://510kreport.com/device/K130141
Methodology: https://510kreport.com/methodology