# K030169: Setpoint Chemistry Calibrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Jan 31, 2003 after 14 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: 1 generation back to K990460 (1999). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K990460: Calibrator for Automated Systems (C.F.a.S.), Roche Diagnostics Corp. (1999) Summary page 1.

## Most influential descendants
- K031682: Lipoprotein Calibrator (2003), 2 descendants of its own
- 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
- K031683: Tox Ammonia Calibrator (2003), 0 descendants of its own

## Indications for use
Bayer SETpoint Calibrator is intended for in vitro diagnostic use to calibrate the following systems: Technicon RA and opeRA Chemistry Systems, Technicon RA-100, Technicon DAX, ADVIA 1650/ADVIA 2400 Chemistry systems, and ADVIA IMS Chemistry systems.

Source page: https://510kreport.com/device/K030169
Methodology: https://510kreport.com/methodology