# K120369: Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: May 10, 2012 after 94 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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.
- K072140: S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test Glu, Alfa Wassermann Diagnostic Technologies, Inc. (2008) Summary page 1.

## Indications for use
The S TEST reagent cartridge for glucose is intended for the quantitative measurement of glucose in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemnia.

Source page: https://510kreport.com/device/K120369
Methodology: https://510kreport.com/methodology