# K051619: Lipoprotein for Multiple Analytes

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Aug 1, 2005 after 45 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990460 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031682: Lipoprotein Calibrator, Bayer Healthcare, LLC (2003) Summary page 2.

## Most influential descendants
- K061139: Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators (2006), 0 descendants of its own

## Indications for use
The Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein Al, Apolipoprotein B and the Direct HDL assays on the ADVIA® IMS Chemistry systems.

Source page: https://510kreport.com/device/K051619
Methodology: https://510kreport.com/methodology