510(k) · Cleared
ClearedNeomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lab Vision Corp. · MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Cleared on Jun 27, 2006 as substantially equivalent to K984567 (Ventana, Inc., 1999) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jun 27, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- MYA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P920006 (1995). 4 ancestors in all, the oldest P880026 (1988). No later device cites it as a predicate yet.
- Root · 2 generations backP920006 Immunocytochemical Assay to Detect ProgesteroneAbbott Laboratories · 1995
- 1 generation backK990618 Ventana PGR Primary Antibody (Clone 1A6)Ventana Medical Systems, Inc. · 1999 · Recalled
- This deviceK061360 Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody…Lab Vision Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P920006 | Immunocytochemical Assay to Detect Progesterone | Abbott Laboratories | 1995 | — |
| −1 | K990618 | Ventana PGR Primary Antibody (Clone 1A6) | Ventana Medical Systems, Inc. | 1999 | 2 |
| 0 (this device) | K061360 | Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1) | Lab Vision Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1999 | 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? (2)
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 |
|---|---|---|---|
| * | K984567 | Ventana ER Primary Antibody (Clone 6F11)Summary page 1…e Devices: NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor Antibody (Clone SP I) is substantially equivalent to the Ventana ER Primary Antibody (Clone 6F 1 ) (K984567) for its stated intended use. 6 ===… | 1999 |
| * | K990618 | Ventana PGR Primary Antibody (Clone 1A6)Summary page 3…Device Subject Device Predicate Ievice Characteristics (K984567) (K990618) Intended Use NeoMarkers Rabbit Monoclonal Anti- Ventana ER Primary Antibody (Clone Human ER A… | 1999 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K984567.
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?
NeoMarkers Rabbit Monoclonal anti-Human ER Antibody (Clone SPI) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061360 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061360: Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061360
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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