510(k) · Cleared
ClearedVision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leica Biosystems Newcastle, Ltd. · MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Cleared on May 19, 2014 as substantially equivalent to K060227 (Vision Biosystems, Inc., 2006) after a 635-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- May 19, 2014
- Review
- 635 days
- Class
- Class II
- Product code
- MYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060227 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060227 Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)Vision Biosystems, Inc. · 2006
- This deviceK122556 Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)Leica Biosystems Newcastle, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060227 | Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) | Vision Biosystems, Inc. | 2006 | — |
| 0 (this device) | K122556 | Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) | Leica Biosystems Newcastle, Ltd. | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060227 | Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)Summary page 29…Clone 6F11 Liquid Concentrate Primary Antibody, NovocastraTM of estrogen receptor on the Bond Ill demonstrate similar performance to the predicate device K060227 for the indication for use, device design, material, operational principles and intended use. Leica Biosystems Newcas… | 2006 |
| † | K110215 | Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody | 2012 |
| † | K042884 | Dakocytomation ER/PR Pharmdx Kit | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MYA devicesMYA Immunohistochemistry Antibody Assay, Estrogen Receptor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MYA
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MYA
Too few MYA 510(k)s in any year since 2007 to give a median.
Recalls per year · MYA
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MYA
2in 2025
MAUDE reports naming product code MYA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Estrogen Receptor Clone 6F1 I (ER 6F 1I) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 611 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells. Estrogen Receptor Clone 611 is indicated as an aid in the…
Read the full statement (155 words)
Estrogen Receptor Clone 6F1 I (ER 6F 1I) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 611 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.
Estrogen Receptor Clone 611 is indicated as an aid in the management, prognosis and predication of therapy outcome of breast cancer. 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 qualified pathologist.
Estrogen Receptor Clone 611 Ready-to-Use Primary Antibody for BondTM and the Estrogen Receptor Clone 6F1 I Liquid Concentrate Primary Antibody, NovocastraTM are optimized for use on the Leica Biosystems Bond III staining platform using the Bond Polymer Refine Detection Kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122556: Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122556
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026