# K130685: Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and Amy

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: Aug 9, 2013 after 149 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- 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 1.

## Indications for use
The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for the quantitative determination of LD in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of LD are used in the diagnosis and treatment of liver and cardiac diseases. The S TEST Reagent Cartridge Amylase (AMY) is intended for the quantitative determination of AMY in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Amylase (AMY) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of AMY are mainly used in the diagnosis and treatment of pancreatic diseases.

Source page: https://510kreport.com/device/K130685
Methodology: https://510kreport.com/methodology