PMA · Approved
ApprovedAbbott PGR-Eia Monoclonal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LPI Kit, Assay, Progesterone Receptor
Approved on Sep 6, 1990 through premarket approval, which rests on the device’s own clinical evidence after a 202-day review. 2 of the 11 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.
- Decided
- Sep 6, 1990
- Review
- 202 days
- Class
- Class III
- Product code
- LPI
- Recalls
- None
10 later devices descend from it, 1 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- This deviceP900013 Abbott PGR-Eia MonoclonalAbbott Laboratories · 1990
- Descendant · cites it directly · 9 of its ownK020023 Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR…Dako Corp. · 2002
- 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
- Descendant · 3 generations on · 1 of its ownK081286 Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone…Dako North America, Inc. · 2009
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K020023Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for…Dako Corp. · 2002 · 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
- K081286Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634Dako North America, Inc. · 2009 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P900013 | Abbott PGR-Eia Monoclonal | Abbott Laboratories | 1990 | — |
| +1 | K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636… | Dako Corp. | 2002 | — |
| +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 | — |
| +3 | K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model… | Dako North America, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 1 |
| 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.
2 devices in this family have 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? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for… | 2002 | 9 |
Has anything in its family been recalled? (2 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.
- K103818Confirm Anti-Progestorone Receptor (1E2) Rabbit Monoclonal Primary AntibodyVentana Medical Sytems, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- 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, K020023 (Dako Corp., 2002) has gone furthest, with 9 descendants of its own.
How does its category compare?
All LPI devicesLPI Kit, Assay, Progesterone Receptor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPI
FDA has decided no LPI device since 2007.
Median 510(k) review, days · LPI
Too few LPI 510(k)s in any year since 2007 to give a median.
Recalls per year · LPI
No recall names LPI since 2007.
Adverse event reports per year · LPI
No MAUDE report names LPI 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/P900013 · printed Nov 6, 2026
Cite this page
510(k) Report. “P900013: Abbott PGR-Eia Monoclonal.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P900013
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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