# P900013: Abbott PGR-Eia Monoclonal

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Sep 6, 1990 after 202 days
- Product code: LPI (Kit, Assay, Progesterone Receptor)
- Device class: 3
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K020023: Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining (2002), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/P900013
Methodology: https://510kreport.com/methodology