# K020724: Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 9, 2002 after 64 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: 1 generation back to K971573 (1997). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971573: N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set, Genzyme Corp. (1997) Summary page 1.
- (no number) Beta-Quantification reference method utilized by the Cholesterol Reference Method Laboratory Network (CRMLN): named in the summary without a submission number

## Most influential descendants
- K063841: NMR Profiler and NMR Lipoprofile Assay, Controls (2008), 4 descendants of its own
- K111516: NMR Lipoprofile (R) Test and NMR Profiler (2011), 2 descendants of its own
- K113830: Vantera Clinical Analyzer (2012), 1 descendant of its own
- K061655: Dimension Vista Flex Reagent Cartridges (2006), 1 descendant of its own
- K241800: Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (2024), 0 descendants of its own

## Indications for use
The Dade Behring Dimension® Automated LDL Cholesterol Flex® reagent cartridge method is an in vitro diagnostic test intended for the quantitative determination of low-density lipoprotein cholesterol in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Source page: https://510kreport.com/device/K020724
Methodology: https://510kreport.com/methodology