# K984567: Ventana ER Primary Antibody (Clone 6F11)

- Pathway: 510(k) (Traditional)
- Applicant: Ventana, Inc.
- Decided: Aug 12, 1999 after 232 days
- Product code: MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P880026 (1988). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P880026: Abbott ER-Ica Monoclonal, Abbott Laboratories (1988) Summary page 1.

## Most influential descendants
- K042884: Dakocytomation ER/PR Pharmdx Kit (2005), 7 descendants of its own
- K130861: Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link) (2013), 2 descendants of its own
- K120663: Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi (2013), 2 descendants of its own
- K081286: Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634 (2009), 1 descendant of its own
- K170028: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) (2017), 0 descendants of its own

## Recalls of this device
- May 16, 2011 · Not classified · Z-2717-2011: The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection K
- May 16, 2011 · Not classified · Z-2716-2011: The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection K

## Indications for use
Ventana Medical Systems’ ER Primary Antibody (Clone 6F11) may be used in immunohistochemical methods to aid in the identification of estrogen receptor (ER) antigen in normal and neoplastic cells'as an aid in the diagnosis of ER positive tumors. The anti-ER (Clone 6F11) is intended for laboratory use to qualitatively stain ER antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated slide staining device. It is further intended as an aid in the assessment of prognosis in the evaluation of breast cancer. Detection chemistries used by Ventana to detect ER are DAB, AEC, Alkaline phosphatase red and blue. Light microscopy is used to detect the staining of cell components. It is indicated for use in the management, prognosis and prediction of therapy outcome of breast cancer.

Source page: https://510kreport.com/device/K984567
Methodology: https://510kreport.com/methodology