# K993957: Dako Monoclonal Mouse Anti-Human Estrogen Receptor

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Mar 3, 2000 after 102 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 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

## Indications for use
Monoclonal Mouse Anti-Human Estrogen Receptor, Clone 1D5 may be used in the semi-quantitative detection of human estrogen receptor in 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. The 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 individual having knowledge of all the potential antibody reactivities.

Source page: https://510kreport.com/device/K993957
Methodology: https://510kreport.com/methodology