510(k) · Cleared
Recalled · Class I · 2018Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Cleared on Dec 17, 2012 as substantially equivalent to K081286 (Dako North America, Inc., 2009) after a 719-day review. Its family tree reaches back 4 generations to 1988. 1 of the 8 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Dec 17, 2012
- Review
- 719 days
- Class
- Class II
- Product code
- MYA
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to P880026 (1988). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backP880026 Abbott ER-Ica MonoclonalAbbott Laboratories · 1988
- 3 generations backK984567 Ventana ER Primary Antibody (Clone 6F11)Ventana, Inc. · 1999 · Recalled
- 2 generations backK042884 Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005
- 1 generation backK081286 Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone…Dako North America, Inc. · 2009
- This deviceK110215 Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary…Ventana Medical Systems, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P880026 | Abbott ER-Ica Monoclonal | Abbott Laboratories | 1988 | — |
| −3 | K984567 | Ventana ER Primary Antibody (Clone 6F11) | Ventana, Inc. | 1999 | 2 |
| −2 | K042884 | Dakocytomation ER/PR Pharmdx Kit | Dakocytomation California, Inc. | 2005 | — |
| −1 | K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model… | Dako North America, Inc. | 2009 | — |
| 0 (this device) | K110215 | Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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.
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 |
|---|---|---|---|
| * | K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634Summary page 1…ER (SPi) Classification Name: Immunohistochemistry Antibody Assay, Estrogen Receptor PREDICATE DEVICE FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a Clone SP 1(081286) DEVICE DESCRIPTION CONFIRM anti-ER (SF1) binds to human estrogen receptor alpha (ER) in paraffin embedded tissue sections. Th… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2018 | Class I | Z-3007-2018 | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
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. 2012, 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?
This antibody is intended for in vitro diagnostic (IVD) use. CONFIRM anti-Estrogen Receptor (ER) (SP1i) Rabbit Monoclonal Primary Antibody is intended for laboratory use for the qualitative detection of estrogen receptor (ER) antigen in sections of formalin-fixed, paraffin-embedded breast tissue on a Ventana automated slide stainer with Ventana detection kits and ancillary reagents. CONFIRM anti-ER (SPi) is directed against an epitope present on human ER…
Read the full statement (118 words)
This antibody is intended for in vitro diagnostic (IVD) use.
CONFIRM anti-Estrogen Receptor (ER) (SP1i) Rabbit Monoclonal Primary Antibody is intended for laboratory use for the qualitative detection of estrogen receptor (ER) antigen in sections of formalin-fixed, paraffin-embedded breast tissue on a Ventana automated slide stainer with Ventana detection kits and ancillary reagents. CONFIRM anti-ER (SPi) is directed against an epitope present on human ER alpha protein located in the nucleus of ER positive normal and neoplastic cells. CONFIRM anti-ER (SPi) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110215: Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110215
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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