510(k) · Cleared
Recalled · 2011Ventana ER Primary Antibody (Clone 6F11)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana, Inc. · MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Cleared on Aug 12, 1999 as substantially equivalent to P880026 (Abbott Laboratories, 1988) after a 232-day review. Its family tree reaches back 1 generation to 1988. 1 of the 11 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 12, 1999
- Review
- 232 days
- Class
- Class II
- Product code
- MYA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to P880026 (1988). 9 later devices descend from it, 2 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backP880026 Abbott ER-Ica MonoclonalAbbott Laboratories · 1988
- This deviceK984567 Ventana ER Primary Antibody (Clone 6F11)Ventana, Inc. · 1999
- Descendant · cites it directly · 7 of its ownK042884 Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK130861 Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636…Dako North America, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK120663 Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK081286 Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone…Dako North America, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK170028 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI…Dako Denmark A/S · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K110215 Confirm Anti-Estrogen Receptor (SP1) Rabbit…3 generations on · 2012
Most influential descendants
Showing 5 of 9 · See all- K042884Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005 · cites it directly7descendants
- K130861Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link)Dako North America, Inc. · 2013 · 2 generations on2descendants
- K120663Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013 · 2 generations on2descendants
- K081286Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634Dako North America, Inc. · 2009 · 2 generations on1descendant
- K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)Dako Denmark A/S · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P880026 | Abbott ER-Ica Monoclonal | Abbott Laboratories | 1988 | — |
| 0 (this device) | K984567 | Ventana ER Primary Antibody (Clone 6F11) | Ventana, Inc. | 1999 | — |
| +1 | K042884 | Dakocytomation ER/PR Pharmdx Kit | Dakocytomation California, Inc. | 2005 | — |
| +2 | K130861 | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use… | Dako North America, Inc. | 2013 | — |
| +2 | K120663 | Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi | Dako North America, Inc. | 2013 | — |
| +2 | K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model… | Dako North America, Inc. | 2009 | — |
| +3 | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako… | Dako Denmark A/S | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | P880026 | Abbott ER-Ica MonoclonalSummary page 1…lent to commercially available Abbot Laboratories’ ER-ICA Monoclonal, Immunocytochemical Assay for the Detection of Human Estrogen Receptor, approved by the FDA as PMA # P880026 and downclassified to class II by 21 CFR 864.1860 Immunohistochemistry Reagents and Kits on June 3, 1998. Description: Ventana'… | 1988 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2011 | Not classified | Z-2717-2011 | Pending | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885… |
| May 16, 2011 | Not classified | Z-2716-2011 | Pending | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K110215Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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.
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?
Ventana Medical Systems’ ER Primary Antibody (Clone 6F11) may be used in immunohistochemical methods to aid in the identification of estrogen receptor (ER) antigen in normal and neoplastic cells'as an aid in the diagnosis of ER positive tumors. The anti-ER (Clone 6F11) is intended for laboratory use to qualitatively stain ER antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated slide staining device. It is further…
Read the full statement (129 words)
Ventana Medical Systems’ ER Primary Antibody (Clone 6F11) may be used in immunohistochemical methods to aid in the identification of estrogen receptor (ER) antigen in normal and neoplastic cells'as an aid in the diagnosis of ER positive tumors. The anti-ER (Clone 6F11) is intended for laboratory use to qualitatively stain ER antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated slide staining device. It is further intended as an aid in the assessment of prognosis in the evaluation of breast cancer. Detection chemistries used by Ventana to detect ER are DAB, AEC, Alkaline phosphatase red and blue. Light microscopy is used to detect the staining of cell components. It is indicated for use in the management, prognosis and prediction of therapy outcome of breast cancer.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984567 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984567: Ventana ER Primary Antibody (Clone 6F11).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984567
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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