510(k) · Cleared
Recalled · 2011Ventana PGR Primary Antibody (Clone 1A6)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Cleared on Jul 23, 1999 as substantially equivalent to P920006 (Abbott Laboratories, 1995) after a 148-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 23, 1999
- Review
- 148 days
- Class
- Class II
- Product code
- MXZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to P920006 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP920006 Immunocytochemical Assay to Detect ProgesteroneAbbott Laboratories · 1995
- This deviceK990618 Ventana PGR Primary Antibody (Clone 1A6)Ventana Medical Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK061360 Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody…Lab Vision Corp. · 2006
- Descendant · cites it directly · 0 of its ownK012960 Biogenex Monoclonal Anti-Progesterone ReceptorBiogenex Laboratories · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P920006 | Immunocytochemical Assay to Detect Progesterone | Abbott Laboratories | 1995 | — |
| 0 (this device) | K990618 | Ventana PGR Primary Antibody (Clone 1A6) | Ventana Medical Systems, Inc. | 1999 | — |
| +1 | K061360 | Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1) | Lab Vision Corp. | 2006 | — |
| +1 | K012960 | Biogenex Monoclonal Anti-Progesterone Receptor | Biogenex Laboratories | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | P920006 | Immunocytochemical Assay to Detect ProgesteroneSummary page 5…confidence interval of 76 — 96%. Conclusions: Ventana claims that PGR Primary Antibody (Clone 1A6) is substantially equivalent to Abbott PgR-ICA Monoclonal, subject of P920006, which was downclassified from class III to Class Il as a result of 21 CFR 864.1860, Immunohistochemistry Reagents and Kits. Perf… | 1995 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2011 | Not classified | Z-2717-2011 | Pending | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885… |
| May 16, 2011 | Not classified | Z-2716-2011 | Pending | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K061360 (Lab Vision Corp., 2006) has gone furthest, with 0 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?
Ventana Medical Systems’ PGR Primary Antibody (Clone 1A6) may be used in immunohistochemical methods to aid in the identification of progesterone receptor (PGR) antigen in normal and neoplastic cells as an aid in the diagnosis of PGR positive tumors. The anti-PGR is intended for laboratory use to qualitatively stain PGR antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated slide staining device. Detection chemistries used…
Read the full statement (113 words)
Ventana Medical Systems’ PGR Primary Antibody (Clone 1A6) may be used in immunohistochemical methods to aid in the identification of progesterone receptor (PGR) antigen in normal and neoplastic cells as an aid in the diagnosis of PGR positive tumors. The anti-PGR is intended for laboratory use to qualitatively stain PGR antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated slide staining device. Detection chemistries used by Ventana to detect PGR are DAB, AEC, Alkaline phosphatase red and blue. Light microscopy is used to detect the staining of cell components. It is indicated for use as an aid in the management, prognosis and prediction of therapy outcome of breast cancer.
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/K990618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990618: Ventana PGR Primary Antibody (Clone 1A6).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990618
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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