# K212223: Atellica CH Enzymatic Creatinine_3 (ECre3)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Nov 24, 2021 after 131 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973993 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070727: Advia Chemistry Enzymatic Creatinine_2, Siemens Medical Solutions Diagnostics (2007) Summary page 4.

## Indications for use
The Atellica@ CH Enzymatic Creatinine_3 (ECre3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin and dipotassium EDTA), and urine using the Atellica@ CH Analyzer. Such measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Source page: https://510kreport.com/device/K212223
Methodology: https://510kreport.com/methodology