# K130861: Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link)

- Pathway: 510(k) (Traditional)
- Applicant: Dako North America, Inc.
- Decided: Dec 9, 2013 after 256 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: 3 generations back to P880026 (1988). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have 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
- K170005: FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) (2017), 0 descendants of its own
- K160922: FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) (2016), 0 descendants of its own

## Indications for use
For in vitro diagnostic use. FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636. Ready-to-Use, (LINK) is intended for use in immunohistochemistry with EnVision FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semiquantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma, This antibody labels progesterone receptor positive cells and is useful in the assessment of progesterone receptor status in human breast carcinomas. 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.

Source page: https://510kreport.com/device/K130861
Methodology: https://510kreport.com/methodology