# K061360: Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1)

- Pathway: 510(k) (Traditional)
- Applicant: Lab Vision Corp.
- Decided: Jun 27, 2006 after 42 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: 2 generations back to P920006 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984567: Ventana ER Primary Antibody (Clone 6F11), Ventana, Inc. (1999) Summary page 1.
- K990618: Ventana PGR Primary Antibody (Clone 1A6), Ventana Medical Systems, Inc. (1999) Summary page 3.

## Indications for use
NeoMarkers Rabbit Monoclonal anti-Human ER Antibody (Clone SPI) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.

Source page: https://510kreport.com/device/K061360
Methodology: https://510kreport.com/methodology