# Leica Biosystems ER clone 6F11 and PR clone 16 antibodies (Novocastra, BOND)

Source: https://onco.cc/drugs/leica-er-pr-ihc/  
OnCo record `leica-er-pr-ihc` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Leica's antibodies for staining the oestrogen receptor (clone 6F11) and progesterone receptor (clone 16) in breast cancer tissue, including ready-to-use versions for its BOND stainers.

## Summary

FDA 510(k) clearances under 21 CFR 864.1860 (class II), from the openFDA database: oestrogen receptor clone 6F11, first as Vision Biosystems (K060227, 25 May 2006), then Leica Biosystems Newcastle (K122556, 19 May 2014) and the BOND ready-to-use and Novocastra liquid concentrate (K183100, 7 December 2018); progesterone receptor clone 16, first as Vision Biosystems (K062615, 29 January 2007), then BOND ready-to-use and Novocastra liquid (K171753, 21 July 2017; K183102, 7 December 2018; K193393, 6 March 2020). The ASCO and College of American Pathologists guideline (Hammond et al., Journal of Clinical Oncology 2010) recommends that oestrogen and progesterone receptor status be determined on all invasive breast cancers and recurrences, and that an assay count as positive if at least 1% of tumour nuclei stain; it found that up to 20% of receptor tests worldwide might be inaccurate.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: Novocastra ER 6F11; Novocastra PR 16; BOND ER 6F11; BOND PR 16
- Tags: test; ihc-assay
- Brand: Novocastra ER 6F11 / PR 16
- Modality: Immunohistochemistry assay (oestrogen and progesterone receptor protein, breast tumour tissue)
- Mechanism: An antibody that binds the receptor protein is applied to a thin slice of the tumour; a chemical stain makes the cells carrying the receptor visible, and a pathologist reports the share of tumour cells that stain and how strongly.
- Approvals: US 2006: Oestrogen receptor IHC, clone 6F11 (510(k) K060227); US 2007: Progesterone receptor IHC, clone 16 (510(k) K062615)

## Sources

- FDA 510(k) K060227: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K060227
- FDA 510(k) K122556: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122556
- FDA 510(k) K183100: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183100
- FDA 510(k) K062615: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K062615
- FDA 510(k) K171753: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171753
- FDA 510(k) K183102: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183102
- FDA 510(k) K193393: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193393

## Connected records

- biomarkers: [ER status (oestrogen receptor by IHC)](https://onco.cc/biomarkers/er-status/), [PR status (progesterone receptor by IHC)](https://onco.cc/biomarkers/pr-status/)
- drugs: [Agilent (Dako) ER and PR immunohistochemistry: ER/PR pharmDx, ER clone EP1, PR clones PgR 636 and PgR 1294](https://onco.cc/drugs/dako-er-pr-ihc/), [VENTANA CONFIRM anti-ER (SP1) and anti-PR (1E2) antibodies](https://onco.cc/drugs/ventana-confirm-er-pr/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- targets: [Estrogen receptor (ERα)](https://onco.cc/targets/estrogen-receptor/), [Progesterone receptor (PGR)](https://onco.cc/targets/pgr/)
- companies: [Leica Biosystems (Danaher)](https://onco.cc/companies/leica-biosystems/)
- terms: [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)
- key papers: [American Society of Clinical Oncology/College Of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer](https://onco.cc/key-papers/paper-asco-cap-er-pr-testing-guideline-jco-2010/)

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