BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171753 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 liquid mouse monoclonal antibody clone 16. It is intended for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue.
It is supplied in a ready-to-use format for use with the automated BOND-MAX and BOND-III systems. The device is classified as a Class II medical device under regulation number 864.1860 and has received FDA 510(k) clearance (K171753) as substantially equivalent.
Frequently asked questions
What is the intended use of the BOND RTU Progesterone Receptor Clone 16 antibody?
It is intended for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue, enabling assessment of hormone receptor status in diagnostic pathology.
How is the BOND RTU Progesterone Receptor Clone 16 antibody supplied and prepared for use?
It is supplied in a ready-to-use (RTU) liquid format, requiring no dilution or additional preparation before application on the automated BOND-MAX and BOND-III immunohistochemistry systems.
Is the BOND RTU Progesterone Receptor Clone 16 antibody designed for single-use or multiple applications?
As a ready-to-use reagent intended for automated staining platforms, it is designed for single-use per test run to ensure consistent performance and avoid contamination or reagent degradation.
What storage conditions are recommended for the BOND RTU Progesterone Receptor Clone 16 antibody?
While specific storage conditions are not detailed in the provided data, ready-to-use antibodies of this type are typically stored at 2–8°C to maintain stability and antigen-binding activity until the expiration date.
What regulatory pathway was used for the BOND RTU Progesterone Receptor Clone 16 antibody?
The device received FDA 510(k) clearance (K171753) as substantially equivalent to a legally marketed predicate device, classified as a Class II medical device under regulation 864.1860.
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… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171753 | Class II | Active |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA 510(k) K171753 24 fields · synced Sep 25, 2026