Immunohistochemistry Assay, Antibody, Progesterone Receptor
The Immunohistochemistry Assay for Progesterone Receptor Antibody is an in vitro diagnostic test used in histological laboratory settings to detect the presence of progesterone receptor (PR) proteins in tissue sections, primarily for breast cancer diagnosis and treatment planning. PR status is an important biomarker that guides hormonal therapy decisions. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 864.1860 (Hematology specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MXZ
- Device Class
- FDA class 2
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | Mar 06, 2020 | Substantially Equivalent | Leica Biosystems Newcastle, Ltd. |
| K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | Dec 07, 2018 | Substantially Equivalent | Leica Biosystems Newcastle, Limited |
| K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | Dec 21, 2017 | Substantially Equivalent | Dako Denmark A/S |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | Jul 21, 2017 | Substantially Equivalent | Leica Biosystems Newcastle, Limited |
| K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) | May 03, 2016 | Substantially Equivalent | Dako North America, Inc. |
| K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | Dec 09, 2013 | Substantially Equivalent | Dako North America, Inc. |
| K103818 | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | Nov 16, 2011 | Substantially Equivalent | Ventana Medical Sytems, Inc. |
| K062615 | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 | Jan 29, 2007 | Substantially Equivalent | Vision Biosystems, Inc. |
| K060462 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) | Apr 24, 2006 | Substantially Equivalent | Lab Vision Corp. |
| K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT | Feb 15, 2005 | Substantially Equivalent | Dakocytomation California, Inc. |
| K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | Mar 08, 2002 | Substantially Equivalent | Biogenex Laboratories |
| K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | Feb 28, 2002 | Substantially Equivalent | Dako Corp. |
| K990618 | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) | Jul 23, 1999 | Substantially Equivalent | Ventana Medical Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.