Rianen (3H) Progestin Receptor Assay Kit
by Dupont Legal
PMA P820052
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP820052 | Date8 Feb 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Rianen(Tm) (3H) Progestin Receptor Assay Kit
- Generic Name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- PMA Number
- FDA Product Code
- LPI
- Device Class
- Class III
- Regulation
- 21 CFR Part 864.1860
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- APPR Approved
- PMA Supplement
- S002
Overview
AI-generated summary, 18 Sep 2026
The Rianen (3H) Progestin Receptor Assay Kit is an in vitro diagnostic device classified as a Kit, Assay, Progesterone Receptor under FDA regulation number 864.1860. It is designed to measure progesterone receptor levels in tissue samples, aiding in the assessment of hormone receptor status for diagnostic purposes in clinical chemistry and hematology settings.
This assay kit is intended for single-use in laboratory environments and requires FDA PMA authorization (PMA Number: P820052). Supplied as a complete reagent system, it is used to evaluate tissue samples for progesterone receptor binding, supporting clinical decision-making. The device is regulated under Class III designation and falls under product code LPI for in vitro diagnostic use.
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Questions
AI-generated answers, 18 Sep 2026
What clinical specialties primarily use the Rianen™ (3H) Progestin Receptor Assay Kit in their diagnostic workflows?
The Rianen™ (3H) Progestin Receptor Assay Kit is designed for use in **clinical chemistry** and **hematology** settings. It helps assess progesterone receptor levels in tissue samples, which is particularly relevant for evaluating hormone receptor status in conditions like breast cancer, where receptor analysis guides treatment decisions.
How is the Rianen™ (3H) Progestin Receptor Assay Kit supplied, and is it intended for single-use or repeated use?
The kit is supplied as a **complete reagent system**, meaning it includes all necessary components for performing the assay in a single procedure. It is explicitly intended for **single-use only** in laboratory environments, ensuring accuracy and sterility for each test.
What regulatory pathway does the Rianen™ (3H) Progestin Receptor Assay Kit follow, and what does that mean for its use?
The kit follows the **FDA Premarket Approval (PMA)** pathway, as indicated by its PMA number (**P820052**). This means it has undergone rigorous review by the FDA to demonstrate safety and effectiveness for its intended use—measuring progesterone receptor levels in tissue samples—before being authorized for clinical diagnostic purposes.
Is the Rianen™ (3H) Progestin Receptor Assay Kit compatible with any specific types of tissue samples?
While the kit is designed to measure progesterone receptor levels in **tissue samples**, the exact types of tissues it can analyze are not specified in the provided data. Typically, such assays are used with biopsy samples (e.g., breast tissue) to evaluate hormone receptor status, but confirmation of compatibility with specific sample types should be verified with the manufacturer’s instructions.