# K073072: Dimension Ahdl Flex Reagent Cartridge, Model: DF48B

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 21, 2008 after 113 days
- Product code: JHM (Colorimetric Method, Lipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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: 2 generations back to K983849 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032798: Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48A, Dade Behring, Inc. (2003) Summary page 1.

## Most influential descendants
- K081300: Dimension Vista HDLC Flex Reagent Cartridge (2008), 0 descendants of its own

## Recalls of this device
- Mar 17, 2016 · Class II · Z-1663-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre
- Mar 17, 2016 · Class II · Z-1659-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre

## Indications for use
The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Source page: https://510kreport.com/device/K073072
Methodology: https://510kreport.com/methodology