# K030452: Bayer Ligand Plus 1, 2, 3 Controls

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Diagnostics Corp.
- Decided: Mar 3, 2003 after 20 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 K901212 (1990). 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)
- K901212: Lig/TDM a, B, C, Ciba Corning Diagnostics Corp. (1990) Summary page 1.

## Most influential descendants
- K060359: Archiect Insulin and Controls, Model 8K41-01, 8K41-10 (2006), 1 descendant of its own
- K171168: VITROS Immunodiagnostic Products Insulin Calibrators (2017), 0 descendants of its own
- K082141: Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10 (2008), 0 descendants of its own

## Indications for use
Assayed control material for in vitro diagnostic use to monitor the precision and accuracy of immunochemistry test procedures for the ADVIA Centaur@ andACS: 1808 Systems.

Source page: https://510kreport.com/device/K030452
Methodology: https://510kreport.com/methodology