# K031682: Lipoprotein Calibrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Jun 25, 2003 after 26 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: 2 generations back to K990460 (1999). 2 ancestors in all.
2 later devices descend 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)
- K030169: Setpoint Chemistry Calibrator, Bayer Healthcare, LLC (2003)

## Most influential descendants
- K051619: Lipoprotein for Multiple Analytes (2005), 1 descendant of its own
- K061139: Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators (2006), 0 descendants of its own

## Indications for use
Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B assays on the ADVIA IMS Chemistry systems.

Source page: https://510kreport.com/device/K031682
Methodology: https://510kreport.com/methodology