# K024017: Bayer Advia Centaur Her-2/Neu Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jan 30, 2003 after 57 days
- Product code: NCW (System, Test, Her-2/Neu, Monitoring)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992228 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992228: Bayer Immuno 1 Her-2/Neu Assay, Bayer Corp. (2000) Summary page 1.

## Recalls of this device
- Aug 25, 2020 · Class II · Z-0115-2021: Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.

## Indications for use
For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum using the ADVIA Centaur System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of HER-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established. This test should be used by or under the order of a physician. This assay is not intended for use on any other system.

Source page: https://510kreport.com/device/K024017
Methodology: https://510kreport.com/methodology