# K161494: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Nov 15, 2016 after 167 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973993 (1998). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 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 5.
- K050374: Advia Ims Lithium Assay, Bayer Healthcare, LLC (2005) Summary page 5.

## Most influential descendants
- K242685: Atellica® CH Creatinine_3 (Crea3) (2024), 1 descendant of its own
- K251058: Tru Kidney Health Test Panel; Tru Analyzer (2025), 0 descendants of its own

## Recalls of this device
- Jun 5, 2020 · Class II · Z-2431-2020: Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

## Indications for use
The Atellica™ CH Creatinine_2 (Crea_2) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin), and urine using the Atellica™ CH Analyzer. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. The Atellica™ CH Chemistry Calibrator (CHEM CAL) is for in vitro diagnostic use in calibrating the Crea_2 assay using the Atellica™ CH Analyzer.

Source page: https://510kreport.com/device/K161494
Methodology: https://510kreport.com/methodology