# K061139: Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Jul 6, 2006 after 73 days
- Product code: JIT (Calibrator, Secondary)
- 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: 4 generations back to K990460 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051619: Lipoprotein for Multiple Analytes, Bayer Healthcare, LLC (2005) Summary page 2.

## Indications for use
For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS System. For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.

Source page: https://510kreport.com/device/K061139
Methodology: https://510kreport.com/methodology