# K033791: Bayer Specific Protein Reference Serum

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Feb 13, 2004 after 71 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 K833402 (1984). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833402: Tech. RA-1000SYS-Analytes Immunoglobulin, Technicon Instruments Corp. (1984) Summary page 1.

## Most influential descendants
- K063150: Complement C3 and C4, Specical Calibrator and Specitrol Control and High Control (2007), 0 descendants of its own

## Indications for use
For in vitro diagnostic use in the calibration of the ADVIA 1650 Technicon RA-500, Technicon RA-1000, Technicon RA-XT, Technicon RA-2000, opeRA chemistry systems specific protein methods.

Source page: https://510kreport.com/device/K033791
Methodology: https://510kreport.com/methodology