# K081300: Dimension Vista HDLC Flex Reagent Cartridge

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jul 2, 2008 after 55 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: 3 generations back to K983849 (1999). 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)
- K073072: Dimension Ahdl Flex Reagent Cartridge, Model: DF48B, Dade Behring, Inc. (2008) Summary page 1.

## Recalls of this device
- Aug 24, 2022 · Class II · Z-0089-2023: Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed o
- Feb 3, 2021 · Class II · Z-1188-2021: Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (

## Indications for use
The HDLC 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 Vista® 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/K081300
Methodology: https://510kreport.com/methodology