MXZ · Immunohistochemistry Assay, Antibody, Progesterone Receptor
Hematology · 21 CFR 864.1860 · Class 2
Overview
| Product Code | MXZ |
|---|---|
| Device Name | Immunohistochemistry Assay, Antibody, Progesterone 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | Leica Biosystems Newcastle, Ltd. | Mar 6, 2020 | SESE |
| K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | Leica Biosystems Newcastle, Limited | Dec 7, 2018 | SESE |
| K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | Dako Denmark A/S | Dec 21, 2017 | SESE |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | Leica Biosystems Newcastle, Limited | Jul 21, 2017 | SESE |
| 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) | Dako North America, Inc. | May 3, 2016 | SESE |
| K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | Dako North America, Inc. | Dec 9, 2013 | SESE |
| K103818 | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Sytems, Inc. | Nov 16, 2011 | SESE |
| K062615 | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 | Vision Biosystems, Inc. | Jan 29, 2007 | SESE |
| K060462 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) | Lab Vision Corp. | Apr 24, 2006 | SESE |
| K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT | Dakocytomation California, Inc. | Feb 15, 2005 | SESE |
| K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | Biogenex Laboratories | Mar 8, 2002 | SESE |
| K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dako Corp. | Feb 28, 2002 | SESE |
| K990618 | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) | Ventana Medical Systems, Inc. | Jul 23, 1999 | SESE |
Top Applicants
- Dako North America, Inc. — 2 clearances
- Leica Biosystems Newcastle, Limited — 2 clearances
- Biogenex Laboratories — 1 clearance
- Dako Corp. — 1 clearance
- Dako Denmark A/S — 1 clearance
