PMA · Approved
ApprovedAbbott ER-Ica Monoclonal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LPJ Kit, Assay, Estrogen Receptor
Approved on Sep 30, 1988 through premarket approval, which rests on the device’s own clinical evidence after a 179-day review. 1 of the 13 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Sep 30, 1988
- Review
- 179 days
- Class
- Class III
- Product code
- LPJ
- Recalls
- None
12 later devices descend from it, 2 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- This deviceP880026 Abbott ER-Ica MonoclonalAbbott Laboratories · 1988
- Descendant · cites it directly · 9 of its ownK993957 Dako Monoclonal Mouse Anti-Human Estrogen ReceptorDako Corp. · 2000
- Descendant · cites it directly · 9 of its ownK984567 Ventana ER Primary Antibody (Clone 6F11)Ventana, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 7 of its ownK042884 Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005
- Descendant · 3 generations on · 2 of its ownK130861 Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636…Dako North America, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK120663 Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K110215 Confirm Anti-Estrogen Receptor (SP1) Rabbit…4 generations on · 2012
Most influential descendants
Showing 5 of 12 · See all- K993957Dako Monoclonal Mouse Anti-Human Estrogen ReceptorDako Corp. · 2000 · cites it directly9descendants
- K984567Ventana ER Primary Antibody (Clone 6F11)Ventana, Inc. · 1999 · cites it directly9descendants
- K042884Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005 · 2 generations on7descendants
- K130861Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link)Dako North America, Inc. · 2013 · 3 generations on2descendants
- K120663Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P880026 | Abbott ER-Ica Monoclonal | Abbott Laboratories | 1988 | — |
| +1 | K993957 | Dako Monoclonal Mouse Anti-Human Estrogen Receptor | Dako Corp. | 2000 | — |
| +1 | K984567 | Ventana ER Primary Antibody (Clone 6F11) | Ventana, Inc. | 1999 | 2 |
| +2 | K042884 | Dakocytomation ER/PR Pharmdx Kit | Dakocytomation California, Inc. | 2005 | — |
| +3 | K130861 | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use… | Dako North America, Inc. | 2013 | — |
| +3 | K120663 | Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi | Dako North America, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (12)
See all 122 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)
No FDA recall names this device.
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 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K993957 (Dako Corp., 2000) has gone furthest, with 9 descendants of its own.
How does its category compare?
All LPJ devicesLPJ Kit, Assay, Estrogen Receptor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPJ
FDA has decided no LPJ device since 2007.
Median 510(k) review, days · LPJ
Too few LPJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LPJ
No recall names LPJ since 2007.
Adverse event reports per year · LPJ
No MAUDE report names LPJ since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P880026 · printed Nov 4, 2026
Cite this page
510(k) Report. “P880026: Abbott ER-Ica Monoclonal.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P880026
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026