# K132462: S Test Reagent Cartridge Bun and S Test Reagent Cartridge Cre

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Chemical Diagnostics, Inc.
- Decided: Oct 28, 2013 after 82 days
- Product code: CDN (Urease, Photometric, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- 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 Blood Urea Nitrogen (BUN) is intended for the quantitative measurement of BUN in serum, lithium heparin plasma. K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. The s TEST Reagent Cartridge Creatinine (CRE) is intended for the quantitative measurement of' creatinine in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the H-itachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. an(] as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K132462
Methodology: https://510kreport.com/methodology