# K160724: ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Sep 7, 2016 after 175 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K834502 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991576: Additional Assays for the Bayer Advia 1650 Chemistry System, Bayer Corp. (1999) Summary page 4.
- K083579: Dimension Vista System Enzyme 6 Calibrator, Model KC360, Siemens Healthcare Diagnostics (2009) Summary page 4.

## Recalls of this device
- May 3, 2019 · Class II · Z-1914-2019: A steady upward trend in blank (u) absorbance was observed
- May 3, 2019 · Class II · Z-1913-2019: A steady upward trend in blank (u) absorbance was observed

## Indications for use
ADVIA Chemistry® Creatine Kinase (CK_L) Assay: The ADVIA Chemistry® Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy. ADVIA Chemistry® Enzyme 3 Calibrator: ADVIA Chemistry® Enzyme 3 Calibrator is intended for in vitro diagnostic use in the calibration of the ADVIA Chemistry Creatine Kinase (CK_L) assay on the ADVIA Chemistry systems.

Source page: https://510kreport.com/device/K160724
Methodology: https://510kreport.com/methodology