# K241800: Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 26, 2024 after 35 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K971573 (1997). 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)
- K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator, Genzyme Corp. (2002) Summary page 4.
- K020724: Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131, Dade Behring, Inc. (2002) Summary page 4.

## Indications for use
The Atellica® CH HDL Cholesterol (HDLC) assay is for in vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) using the Atellica® CH Analyzer. HDLC measurements are used in the diagnosis and treatment of atherosclerosis. The Atellica® CH LDL Cholesterol (LDLC) assay is for in vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin) using the Atellica® CH Analyzer. LDLC measurements are used in the diagnosis and treatment of atherosclerosis

Source page: https://510kreport.com/device/K241800
Methodology: https://510kreport.com/methodology