# K060227: Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)

- Pathway: 510(k) (Abbreviated)
- Applicant: Vision Biosystems, Inc.
- Decided: May 25, 2006 after 115 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ventana Medical Systems Estrogen Receptor Clone 6F11: named in the summary without a submission number
- (no number) DAKO Corporation Mouse Monoclonal Estrogen Receptor Clone 1D5: named in the summary without a submission number

## Most influential descendants
- K122556: Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) (2014), 0 descendants of its own

## Indications for use
Vision BioSystems Estrogen Receptor Clone 6F1 1 (ER 6F1 1) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F1 I specifically binds to the ER antigen located inthe nucleus of ER positive normal and neoplastic cells. ER 6Fl1 is indicated as an aid in the management, prognosis and prediction 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 a qualified pathologist. OriginrM antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMarkTM Immunohistochemistry Staining Systems in combination with Ventana® Detection Kits.

Source page: https://510kreport.com/device/K060227
Methodology: https://510kreport.com/methodology