Immunohistochemistry Antibody Assay, Estrogen Receptor
The Immunohistochemistry Antibody Assay for Estrogen Receptor is an in vitro diagnostic test used to detect estrogen receptor (ER) expression in tumor tissue sections through immunohistochemical staining. ER status is a critical biomarker for determining eligibility for hormonal therapies in breast cancer patients. 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
- MYA
- 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 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | Dec 07, 2018 | Substantially Equivalent | Leica Biosystems Newcastle, Limited |
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | Dec 21, 2017 | Substantially Equivalent | Dako Denmark A/S |
| K122556 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | May 19, 2014 | Substantially Equivalent | Leica Biosystems Newcastle, Ltd. |
| K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | Feb 12, 2013 | Substantially Equivalent | Dako North America, Inc. |
| K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | Dec 17, 2012 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | May 08, 2009 | Substantially Equivalent | Dako North America, Inc. |
| K061360 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) | Jun 27, 2006 | Substantially Equivalent | Lab Vision Corp. |
| K060227 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | May 25, 2006 | Substantially Equivalent | Vision Biosystems, Inc. |
| K012138 | MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Sep 30, 2002 | Substantially Equivalent | Chroma Vision Medical Systems, Inc. |
| K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | Feb 28, 2002 | Substantially Equivalent | Biogenex Laboratories |
| K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | Mar 03, 2000 | Substantially Equivalent | Dako Corp. |
| K984567 | VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) | Aug 12, 1999 | Substantially Equivalent | Ventana, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.