# P880026: Abbott ER-Ica Monoclonal

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Sep 30, 1988 after 179 days
- Product code: LPJ (Kit, Assay, Estrogen 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.
12 later devices descend from it; 2 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)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K993957: Dako Monoclonal Mouse Anti-Human Estrogen Receptor (2000), 9 descendants of its own
- K984567: Ventana ER Primary Antibody (Clone 6F11) (1999), 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

Source page: https://510kreport.com/device/P880026
Methodology: https://510kreport.com/methodology