MYA · Immunohistochemistry Antibody Assay, Estrogen Receptor
Hematology · 21 CFR 864.1860 · Class 2
Overview
| Product Code | MYA |
|---|---|
| Device Name | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Regulation | 21 CFR 864.1860 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.
Classification Rationale
(1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. (2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). (3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
Special Controls
(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | Leica Biosystems Newcastle, Limited | Dec 7, 2018 | SESE |
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | Dako Denmark A/S | Dec 21, 2017 | SESE |
| K122556 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | Leica Biosystems Newcastle, Ltd. | May 19, 2014 | SESE |
| K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | Dako North America, Inc. | Feb 12, 2013 | SESE |
| K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Dec 17, 2012 | SESE |
| K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | Dako North America, Inc. | May 8, 2009 | SESE |
| K061360 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) | Lab Vision Corp. | Jun 27, 2006 | SESE |
| K060227 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | Vision Biosystems, Inc. | May 25, 2006 | SESE |
| K012138 | MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Chroma Vision Medical Systems, Inc. | Sep 30, 2002 | SESE |
| K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | Biogenex Laboratories | Feb 28, 2002 | SESE |
| K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | Dako Corp. | Mar 3, 2000 | SESE |
| K984567 | VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) | Ventana, Inc. | Aug 12, 1999 | SESE |
Top Applicants
- Dako North America, Inc. — 2 clearances
- Biogenex Laboratories — 1 clearance
- Chroma Vision Medical Systems, Inc. — 1 clearance
- Dako Corp. — 1 clearance
- Dako Denmark A/S — 1 clearance
