510(k) · Cleared
ClearedBiogenex Monoclonal Anti-Progesterone Receptor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biogenex Laboratories · MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Cleared on Mar 8, 2002 as substantially equivalent to K990618 (Ventana Medical Systems, Inc., 1999) after a 185-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 8, 2002
- Review
- 185 days
- Class
- Class II
- Product code
- MXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P920006 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backP920006 Immunocytochemical Assay to Detect ProgesteroneAbbott Laboratories · 1995
- 1 generation backK990618 Ventana PGR Primary Antibody (Clone 1A6)Ventana Medical Systems, Inc. · 1999 · Recalled
- This deviceK012960 Biogenex Monoclonal Anti-Progesterone ReceptorBiogenex Laboratories · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P920006 | Immunocytochemical Assay to Detect Progesterone | Abbott Laboratories | 1995 | — |
| −1 | K990618 | Ventana PGR Primary Antibody (Clone 1A6) | Ventana Medical Systems, Inc. | 1999 | 2 |
| 0 (this device) | K012960 | Biogenex Monoclonal Anti-Progesterone Receptor | Biogenex Laboratories | 2002 | — |
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? (2)
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 |
|---|---|---|---|
| * | K990618 | Ventana PGR Primary Antibody (Clone 1A6)Summary page 1…(DCC) technique which were common in use prior to May 28, 1976. The device is substantially equivalent in methodology to similar kits for progesterone receptor (Ventana, K990618). 4600 Norris Canyon Rd. San Ramon, CA 94583 Tel 925-275-0550 Fax 925-275-0580 DESCRIPTION OF THE DEVICE: Bi… | 1999 |
| * | — | dextran-coated charcoal (DCC) technique Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K990618.
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 BioGenex Mouse Monoclonal Anti-Progesterone Receptor Antibody (Clone PR88) is an immunohistochemical (IHC) assay and is intended for laboratory use to qualitatively identify by light microscopy human progesterone receptor in normal and/or pathological paraffin-embedded, formalin-fixed tissues. The PR88 antibody specifically binds to antigens located in the nucleus of cell populations that express progesterone receptor in normal and abnormal tissues.…
Read the full statement (146 words)
The BioGenex Mouse Monoclonal Anti-Progesterone Receptor Antibody (Clone PR88) is an immunohistochemical (IHC) assay and is intended for laboratory use to qualitatively identify by light microscopy human progesterone receptor in normal and/or pathological paraffin-embedded, formalin-fixed tissues. The PR88 antibody specifically binds to antigens located in the nucleus of cell populations that express progesterone receptor in normal and abnormal tissues. This antibody is indicated as an aid in assessing patient response to hormonal therapy and as an aid in the prognosis and management of breast cancer patients. 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.
PR88 antibodies have been optimally manufactured for use with BioGenex Super Sensitive MultiLink® Detection Systems with or without BioGenex Automated Staining Systems.
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/K012960 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012960: Biogenex Monoclonal Anti-Progesterone Receptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012960
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026