# K030804: Bayer Advia 1650 Special Chemistry Calibrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Apr 10, 2003 after 28 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 K023840 (2003). 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)
- K023840: Acid Phosphatase Assay for the Advia 1650, Bayer Diagnostics Corp. (2003)

## Most influential descendants
- K033380: Bayer Special Chemistry Calibrators (2003), 0 descendants of its own

## Indications for use
For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

Source page: https://510kreport.com/device/K030804
Methodology: https://510kreport.com/methodology