510(k) · Cleared
ClearedMonoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dako North America, Inc. · MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Cleared on Feb 12, 2013 as substantially equivalent to K042884 (Dakocytomation California, Inc., 2005) after a 344-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Feb 12, 2013
- Review
- 344 days
- Class
- Class II
- Product code
- MYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P880026 (1988). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP880026 Abbott ER-Ica MonoclonalAbbott Laboratories · 1988
- 2 generations backK984567 Ventana ER Primary Antibody (Clone 6F11)Ventana, Inc. · 1999 · Recalled
- 1 generation backK042884 Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005
- This deviceK120663 Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK170028 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI…Dako Denmark A/S · 2017
- Descendant · cites it directly · 0 of its ownK160922 FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1…Dako North America, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See all- K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)Dako Denmark A/S · 2017 · cites it directly0descendants
- K160922FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)…Dako North America, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P880026 | Abbott ER-Ica Monoclonal | Abbott Laboratories | 1988 | — |
| −2 | K984567 | Ventana ER Primary Antibody (Clone 6F11) | Ventana, Inc. | 1999 | 2 |
| −1 | K042884 | Dakocytomation ER/PR Pharmdx Kit | Dakocytomation California, Inc. | 2005 | — |
| 0 (this device) | K120663 | Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi | Dako North America, Inc. | 2013 | — |
| +1 | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako… | Dako Denmark A/S | 2017 | — |
| +1 | K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1… | Dako North America, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 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.
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 |
|---|---|---|---|
| * | K042884 | Dakocytomation ER/PR Pharmdx KitSummary page 2…O D a koER a Clone EPi 7.7 Predicate Device: ER a component of the Dako ER/PR pharmDx M Kit (K042884) 7.8 Device Description Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EPi (Dako Anti-Hu… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K170028 (Dako Denmark A/S, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K042884.
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. 2013, 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?
For in vitro diagnostic use. FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EPi, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVisionTh FLEX, High pH visualization kit together with Autostainer Link 48 to semi-quantitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor α-positive cells and is useful in the…
Read the full statement (108 words)
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EPi, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVisionTh FLEX, High pH visualization kit together with Autostainer Link 48 to semi-quantitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor α-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.
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 a qualified pathologist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120663 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120663: Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120663
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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