# K042884: Dakocytomation ER/PR Pharmdx Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dakocytomation California, Inc.
- Decided: Feb 15, 2005 after 119 days
- Product code: MXZ (Immunohistochemistry Assay, Antibody, Progesterone 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: 2 generations back to P880026 (1988). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993957: Dako Monoclonal Mouse Anti-Human Estrogen Receptor, Dako Corp. (2000) Summary page 1.
- K984567: Ventana ER Primary Antibody (Clone 6F11), Ventana, Inc. (1999) Summary page 1.
- K020023: Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining, Dako Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K170005: FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) (2017), 0 descendants of its own

## Indications for use
The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffin-embedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. 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 The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR protein located in the cell nucleus of ER and PR-expressing cells respectively. ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with anti-hormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer.

Source page: https://510kreport.com/device/K042884
Methodology: https://510kreport.com/methodology