# K983849: Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 11, 1999 after 73 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
No predicates in its family tree.
6 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)
- None. The FDA summary names its predicate without a number.
- (no number) Dimension® High Density Lipoprotein Cholesterol (HDL) Assay: named in the summary without a submission number

## Most influential descendants
- K032798: Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48A (2003), 5 descendants of its own
- 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

## Indications for use
The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements are used as an aid in the diagnosis and treatment of lipid disorders.

Source page: https://510kreport.com/device/K983849
Methodology: https://510kreport.com/methodology