BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastr…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183102 FDA 510(k)
- FDA Product Code
- MXZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.1860 FDA 510(k)
- Regulation Number
- 864.1860 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an immunohistochemistry assay antibody for progesterone receptor, specifically a mouse monoclonal antibody (Clone 16) designed for the qualitative identification of progesterone receptor in formalin-fixed, paraffin-embedded tissue sections by light microscopy. It is intended for use with the automated BOND™ system, including the BOND-MAX and BOND-III platforms.
The device is supplied as a ready-to-use (RTU) concentrated liquid reagent and is used in clinical laboratory settings for immunohistochemical staining. It is a single-use reagent, and its regulatory status is based on FDA 510(k) clearance under product code MXZ, with classification as a Class II device under regulation number 864.1860.
Frequently asked questions
What is the BOND RTU Progesterone Receptor Antibody Clone 16 used for?
This device is a mouse monoclonal antibody (Clone 16) designed for the qualitative identification of progesterone receptor in formalin-fixed, paraffin-embedded tissue sections by light microscopy. It is used in immunohistochemical staining to assess hormone receptor status in clinical pathology, particularly in breast cancer evaluation, to guide treatment decisions based on receptor expression.
How is the BOND RTU Progesterone Receptor Antibody supplied and is it single-use or reusable?
The antibody is supplied as a ready-to-use (RTU) concentrated liquid reagent in a vial format designed for direct use with the BOND™ automated staining systems. It is intended for single-use only; each vial is dedicated to one staining run to prevent contamination and ensure consistent performance, and it should not be reprocessed or reused after initial application.
What equipment is required to use the BOND RTU Progesterone Receptor Antibody Clone 16?
This antibody is specifically designed for use with Leica Biosystems' automated BOND™ platforms, including the BOND-MAX and BOND-III immunostainers. It is optimized for these systems' reagent protocols, temperature control, and detection chemistry, and is not intended for manual staining or use with other automated platforms due to formulation-specific compatibility.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16 ..., BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183102 | Class II | Active |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA 510(k) K183102 24 fields · synced Sep 27, 2026