510(k) · Cleared
ClearedMonoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dako North America, Inc. · MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Cleared on Dec 9, 2013 as substantially equivalent to K042884 (Dakocytomation California, Inc., 2005) after a 256-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Dec 9, 2013
- Review
- 256 days
- Class
- Class II
- Product code
- MXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P880026 (1988). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP880026 Abbott ER-Ica MonoclonalAbbott Laboratories · 1988
- 2 generations backK984567 Ventana ER Primary Antibody (Clone 6F11)Ventana, Inc. · 1999 · Recalled
- 1 generation backK042884 Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005
- This deviceK130861 Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636…Dako North America, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK170005 FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR…Dako Denmark A/S · 2017
- Descendant · cites it directly · 0 of its ownK160922 FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1…Dako North America, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See all- K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use…Dako Denmark A/S · 2017 · cites it directly0descendants
- K160922FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)…Dako North America, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P880026 | Abbott ER-Ica Monoclonal | Abbott Laboratories | 1988 | — |
| −2 | K984567 | Ventana ER Primary Antibody (Clone 6F11) | Ventana, Inc. | 1999 | 2 |
| −1 | K042884 | Dakocytomation ER/PR Pharmdx Kit | Dakocytomation California, Inc. | 2005 | — |
| 0 (this device) | K130861 | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use… | Dako North America, Inc. | 2013 | — |
| +1 | K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294… | Dako Denmark A/S | 2017 | — |
| +1 | K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1… | Dako North America, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 MXZ? 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 |
|---|---|---|---|
| * | K042884 | Dakocytomation ER/PR Pharmdx KitSummary page 1…5.3 Substantially Equivalent Predicate Device Device Name: PR component of the Dako ER/PR pharmDx Tm Kit Device 510O(k): K042884 Dako North America, Inc. 17 6 'Dako A… | 2005 |
| † | K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K170005 (Dako Denmark A/S, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K042884.
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. 2013, this device’s year, is highlighted.
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?
For in vitro diagnostic use. FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636. Ready-to-Use, (LINK) is intended for use in immunohistochemistry with EnVision FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semiquantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma, This antibody labels progesterone receptor positive cells and is useful in the…
Read the full statement (110 words)
For in vitro diagnostic use.
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636. Ready-to-Use, (LINK) is intended for use in immunohistochemistry with EnVision FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semiquantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma, This antibody labels progesterone receptor positive cells and is useful in the assessment of progesterone receptor status in human breast carcinomas.
The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130861: Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130861
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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