510(k) · Cleared
Recalled · Class I · 2018Confirm Anti-Progestorone Receptor (1E2) Rabbit Monoclonal Primary Antibody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Sytems, Inc. · MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Cleared on Nov 16, 2011 as substantially equivalent to K020023 (Dako Corp., 2002) after a 322-day review. Its family tree reaches back 2 generations to 1990. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Nov 16, 2011
- Review
- 322 days
- Class
- Class II
- Product code
- MXZ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to P900013 (1990). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP900013 Abbott PGR-Eia MonoclonalAbbott Laboratories · 1990
- 1 generation backK020023 Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR…Dako Corp. · 2002
- This deviceK103818 Confirm Anti-Progestorone Receptor (1E2) Rabbit Monoclonal Primary…Ventana Medical Sytems, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P900013 | Abbott PGR-Eia Monoclonal | Abbott Laboratories | 1990 | — |
| −1 | K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636… | Dako Corp. | 2002 | — |
| 0 (this device) | K103818 | Confirm Anti-Progestorone Receptor (1E2) Rabbit Monoclonal Primary Antibody | Ventana Medical Sytems, Inc. | 2011 | — |
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? (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 |
|---|---|---|---|
| * | K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for…Summary page 1…ubstantially equivalent to DAKO North America's commercially available Monoclonal Mouse Anti Human Progesterone Receptor, Clone PGR 636 K020023 Device Ventana's CONFIRM anti-Progesterone Receptor (1E2) Rabbit Mooclonal Primary Description Antibody specifical… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2018 | Class I | Z-3006-2018 | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K020023.
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. 2011, 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?
This antibody is intended for in vitro diagnostic (IVO) use. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal (IgG) Primary Antibody is intended for laboratory use for the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-PR (1E2) is directed against an epitope present on…
Read the full statement (121 words)
This antibody is intended for in vitro diagnostic (IVO) use.
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal (IgG) Primary Antibody is intended for laboratory use for the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-PR (1E2) is directed against an epitope present on human progesterone receptor protein located in the nucleus of PIR positive normal and neoplastic cells. CONFIRM anti-PR (1E2) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
Prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103818: Confirm Anti-Progestorone Receptor (1E2) Rabbit Monoclonal Primary Antibody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103818
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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