# K081286: Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634

- Pathway: 510(k) (Traditional)
- Applicant: Dako North America, Inc.
- Decided: May 8, 2009 after 366 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: 3 generations back to P880026 (1988). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042884: Dakocytomation ER/PR Pharmdx Kit, Dakocytomation California, Inc. (2005) Summary page 1.

## Most influential descendants
- K110215: Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody (2012), 0 descendants of its own

## Indications for use
For in vitro diagnostic use. Monoclonal Rabbit Anti-Human Estrogen Receptor α (ER α) antibody, Clone SP1, may be used in the semi-quantitative detection of human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients. Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Source page: https://510kreport.com/device/K081286
Methodology: https://510kreport.com/methodology