# K032798: Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48A

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 30, 2003 after 51 days
- Product code: JHM (Colorimetric Method, Lipoproteins)
- 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 K983849 (1999). 1 ancestor in all.
5 later devices descend from it; 2 cite 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)
- K983849: Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge, Dade Behring, Inc. (1999) Summary page 1.

## Most influential descendants
- K042006: Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace (2004), 2 descendants of its own
- K073072: Dimension Ahdl Flex Reagent Cartridge, Model: DF48B (2008), 1 descendant of its own
- K120609: Vitros Chemistry Products DHDL Slides (2012), 0 descendants of its own
- K081300: Dimension Vista HDLC Flex Reagent Cartridge (2008), 0 descendants of its own
- K052867: Vitros Chemistry Products Dtibc Reagent (2005), 0 descendants of its own

## Indications for use
The AHDL method for the Dimension clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnosis of lipid disorders.

Source page: https://510kreport.com/device/K032798
Methodology: https://510kreport.com/methodology