510(k) · Cleared
ClearedDako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dako Corp. · MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Cleared on Feb 28, 2002 as substantially equivalent to P900013 (Abbott Laboratories, 1990) after a 56-day review. Its family tree reaches back 1 generation to 1990. 2 of the 11 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Feb 28, 2002
- Review
- 56 days
- Class
- Class II
- Product code
- MXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P900013 (1990). 9 later devices descend from it, 2 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backP900013 Abbott PGR-Eia MonoclonalAbbott Laboratories · 1990
- This deviceK020023 Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR…Dako Corp. · 2002
- Descendant · cites it directly · 7 of its ownK042884 Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK130861 Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636…Dako North America, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK120663 Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK081286 Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone…Dako North America, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK170028 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI…Dako Denmark A/S · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K042884Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005 · cites it directly7descendants
- K130861Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link)Dako North America, Inc. · 2013 · 2 generations on2descendants
- K120663Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013 · 2 generations on2descendants
- K081286Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634Dako North America, Inc. · 2009 · 2 generations on1descendant
- K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)Dako Denmark A/S · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P900013 | Abbott PGR-Eia Monoclonal | Abbott Laboratories | 1990 | — |
| 0 (this device) | K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636… | Dako Corp. | 2002 | — |
| +1 | K042884 | Dakocytomation ER/PR Pharmdx Kit | Dakocytomation California, Inc. | 2005 | — |
| +2 | K130861 | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use… | Dako North America, Inc. | 2013 | — |
| +2 | K120663 | Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi | Dako North America, Inc. | 2013 | — |
| +2 | K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model… | Dako North America, Inc. | 2009 | — |
| +3 | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako… | Dako Denmark A/S | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 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.
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.
Top candidate predicates for a new MXZ device
- #1 K193393 BOND Ready-to-Use Primary Antibody…score -1.0 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | P900013 | Abbott PGR-Eia MonoclonalSummary page 1…emical staining reagents (21 CFR 864.1860). Hematology and Pathology Devices Panel, Division of Clinical Laboratory Devices. Abbott PR-EIA approved by the FDA as PMA # P900013 and downclassified to Class Il by 21 CFR 864.1860, Immunohistochemistry Reagents and Kits on June 3, 1998. Device package insert… | 1990 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K110215Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K042884 (Dakocytomation California, Inc., 2005) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MXZ devicesMXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MXZ
Too few MXZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MXZ
No recall names MXZ since 2007.
Adverse event reports per year · MXZ
1in 2025
MAUDE reports naming product code MXZ, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 is intended for use in the qualitative detection of human progesterone receptor in tissue sections of human breast cancer by immunohistochemistry. The assay is intended for use as an aid in selecting patients most likely to benefit from hormonal therapy as well as an aid in the prognosis and management of breast cancer. The clinical interpretation of any positive staining or its absence…
Read the full statement (110 words)
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 is intended for use in the qualitative detection of human progesterone receptor in tissue sections of human breast cancer by immunohistochemistry. The assay is intended for use as an aid in selecting patients most likely to benefit from hormonal therapy as well as an aid in the prognosis and management of breast cancer.
The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual having knowledge of all the potential antibody reactivities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020023 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020023: Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020023
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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