510(k) · Cleared
ClearedDakocytomation ER/PR Pharmdx Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dakocytomation California, Inc. · MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Cleared on Feb 15, 2005 as substantially equivalent to K993957 (Dako Corp., 2000) and 2 other predicates after a 119-day review. Its family tree reaches back 2 generations to 1988. 1 of the 13 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Feb 15, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- MXZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P880026 (1988). 5 ancestors in all. 7 later devices descend from it, 3 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP880026 Abbott ER-Ica MonoclonalAbbott Laboratories · 1988
- 1 generation backK984567 Ventana ER Primary Antibody (Clone 6F11)Ventana, Inc. · 1999 · Recalled
- This deviceK042884 Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK130861 Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636…Dako North America, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK120663 Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK081286 Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone…Dako North America, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK170028 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI…Dako Denmark A/S · 2017
- Descendant · 2 generations on · 0 of its ownK170005 FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR…Dako Denmark A/S · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K110215 Confirm Anti-Estrogen Receptor (SP1) Rabbit…2 generations on · 2012
Most influential descendants
Showing 5 of 7 · See all- K130861Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link)Dako North America, Inc. · 2013 · cites it directly2descendants
- K120663Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EpiDako North America, Inc. · 2013 · cites it directly2descendants
- K081286Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634Dako North America, Inc. · 2009 · cites it directly1descendant
- K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)Dako Denmark A/S · 2017 · 2 generations on0descendants
- K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use…Dako Denmark A/S · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P880026 | Abbott ER-Ica Monoclonal | Abbott Laboratories | 1988 | — |
| −1 | K984567 | Ventana ER Primary Antibody (Clone 6F11) | Ventana, Inc. | 1999 | 2 |
| 0 (this device) | K042884 | Dakocytomation ER/PR Pharmdx Kit | Dakocytomation California, Inc. | 2005 | — |
| +1 | K130861 | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use… | Dako North America, Inc. | 2013 | — |
| +1 | K120663 | Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi | Dako North America, Inc. | 2013 | — |
| +1 | K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model… | Dako North America, Inc. | 2009 | — |
| +2 | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako… | Dako Denmark A/S | 2017 | — |
| +2 | K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294… | Dako Denmark A/S | 2017 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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.
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.
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? (3)
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 |
|---|---|---|---|
| * | K993957 | Dako Monoclonal Mouse Anti-Human Estrogen ReceptorSummary page 1…Estrogen Receptor * DakoCytomation Monoclonal Mouse Anti-Human Estrogen Receptor, Clone 1D5, (K993957) * Ventana ER clone 6F1 1, (K984567) Progesterone Receptor… | 2000 |
| * | K984567 | Ventana ER Primary Antibody (Clone 6F11)Summary page 1…ation Monoclonal Mouse Anti-Human Estrogen Receptor, Clone 1D5, (K993957) * Ventana ER clone 6F1 1, (K984567) Progesterone Receptor * DakoCytomation Monoclonal Mouse Anti-Human… | 1999 |
| * | K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for…Summary page 1…sterone Receptor * DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, (K020023) Device Description: The DakoCytomation ER/PR pharmDxTM assay is a semi-quantitative immunohistochemical (IHC) kit system to ide… | 2002 |
What descends from it? (7)
3 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 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K130861 (Dako North America, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K993957.
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?
The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffin-embedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. The clinical interpretation of any positive staining or its…
Read the full statement (186 words)
The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffin-embedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome 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
The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR protein located in the cell nucleus of ER and PR-expressing cells respectively.
ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with anti-hormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042884: Dakocytomation ER/PR Pharmdx Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042884
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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