# K063608: Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and High

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 23, 2007 after 81 days
- Product code: MSJ (Apolipoproteins)
- 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: 2 generations back to K023158 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 1.
- K041870: N Apolipoprotein Standard Serum, Dade Behring, Inc. (2004) Summary page 1.
- K993310: Apolipoprotein Control Serum CHD, Model Ouph, Dade Behring, Inc. (1999) Summary page 1.

## Most influential descendants
- K181373: Extended Lipid Panel Assay (2018), 0 descendants of its own

## Indications for use
The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-I in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease. The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease. Apolipoprotein Calibrator is an in vitro diagnostic product for the calibration of the Apolipoprotein A-I (APOAI) and Apolipoprotein B (APOB) methods on the Dimension Vista® System. Apolipoprotein Control is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.

Source page: https://510kreport.com/device/K063608
Methodology: https://510kreport.com/methodology