# K030801: Bayer Advia 1650 Special Chemistry Control

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Apr 9, 2003 after 27 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: 1 generation back to K023840 (2003). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K023840: Acid Phosphatase Assay for the Advia 1650, Bayer Diagnostics Corp. (2003)

## Most influential descendants
- K033379: Bayer Special Chemistry Controls (2003), 1 descendant of its own
- K061137: Advia Ims Cpsa Control (2006), 0 descendants of its own
- K031644: Bayer Advia Chemistry Special Chemistry Control (2003), 0 descendants of its own

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

Source page: https://510kreport.com/device/K030801
Methodology: https://510kreport.com/methodology