Fluoro-CEP Estrogen Assay Reagent Kit

No FDA recalls on record, checked 6 Oct 2026.

Full name

Fluoro-Cep{r} Estrogen Assay Reagent

Generic Name

KIT, ASSAY, ESTROGEN RECEPTOR

PMA Number

P860015 ↗

FDA Product Code

LPJ

Device Class

Class III

Regulation

21 CFR Part 864.1860

Advisory Committee

Clinical Chemistry

FDA Decision

APWD Approval withdrawn

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• What clinical specialty or laboratory setting is this assay kit primarily used in?

  This kit is designed for use in clinical chemistry laboratories, specifically within hematology or pathology settings. It aids in assessing hormone receptor status by measuring estrogen receptor levels in tissue samples, which is critical for diagnosing and guiding treatment decisions in hormone-sensitive cancers, such as breast cancer.

• Is this assay kit intended for single-use or repeated use, and how should it be handled?

  The Fluoro-CEP Estrogen Assay Reagent Kit is explicitly designed for **single-use only** as a diagnostic reagent system. It is intended for in vitro laboratory use, meaning it must be used once and then discarded. Sterility and proper handling instructions are detailed in the accompanying documentation to ensure accurate results and compliance with safety protocols.

• What type of assay method does this kit use, and why is it significant?

  This kit employs a **fluorometric assay method**, which measures estrogen receptor levels by detecting fluorescence—a precise and sensitive technique for quantifying hormone receptors in tissue samples. This method is significant because it provides a reliable way to assess hormone receptor status, which is essential for tailoring treatments like hormone therapy in oncology.

• How is this device regulated, and what does the PMA authorization mean for users?

  The Fluoro-CEP Estrogen Assay Reagent is authorized under the **FDA Premarket Approval (PMA) process**, specifically with PMA Number **P860015**. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use—quantitative measurement of estrogen receptors in tissue samples. Users can rely on this authorization as evidence of the kit’s compliance with stringent regulatory standards.

• What documentation or instructions should users refer to for proper storage or handling?

  The kit includes accompanying documentation that specifies **sterility requirements and handling instructions**, which must be followed to maintain accuracy and safety. Since it is a single-use diagnostic reagent, proper storage (as outlined in the documentation) is critical to preserve the integrity of the assay components before use. Always adhere to these guidelines to avoid compromising test results.