# K033379: Bayer Special Chemistry Controls

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Diagnostics Corp.
- Decided: Dec 19, 2003 after 58 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K023840 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030801: Bayer Advia 1650 Special Chemistry Control, Bayer Healthcare, LLC (2003) Summary page 1.

## Most influential descendants
- K061137: Advia Ims Cpsa Control (2006), 0 descendants of its own

## Indications for use
For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.

Source page: https://510kreport.com/device/K033379
Methodology: https://510kreport.com/methodology