# K122556: Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)

- Pathway: 510(k) (Traditional)
- Applicant: Leica Biosystems Newcastle, Ltd.
- Decided: May 19, 2014 after 635 days
- Product code: MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor)
- Device class: 2
- Regulation: 21 CFR 864.1860
- 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 K060227 (2006). 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)
- K060227: Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11), Vision Biosystems, Inc. (2006) Summary page 29.

## Indications for use
Estrogen Receptor Clone 6F1 I (ER 6F 1I) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 611 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells. Estrogen Receptor Clone 611 is indicated as an aid in the management, prognosis and predication of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by qualified pathologist. Estrogen Receptor Clone 611 Ready-to-Use Primary Antibody for BondTM and the Estrogen Receptor Clone 6F1 I Liquid Concentrate Primary Antibody, NovocastraTM are optimized for use on the Leica Biosystems Bond III staining platform using the Bond Polymer Refine Detection Kit.

Source page: https://510kreport.com/device/K122556
Methodology: https://510kreport.com/methodology