PGR-EIA Monoclonal Kit, Assay, Progesterone Receptor
by Abbott Laboratories PMA
Withdrawn
PMA P900013
Overview
The PGR-EIA Monoclonal is a kit used for the assay of progesterone receptors, designed for laboratory testing purposes. This device is classified as a Class III medical device under the regulation number 864.1860, specializing in hematology applications.
The kit is supplied by Abbott Laboratories and is intended for single-use in clinical laboratory settings. It is not indicated for MRI compatibility and requires appropriate storage conditions as specified by the manufacturer. The device received FDA PMA approval on September 6, 1990, with the PMA number P900013.
Regulatory status
Withdrawn since 6 Sep 1990. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP900013 | Date6 Sep 1990 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Specification
- Full name
- Pgr-Eia Monoclonal
- Trade Name
- Abbott Pgr-Eia Monoclonal
- Generic Name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- PMA Number
- FDA Product Code
- LPI
- Regulation
- 21 CFR Part 864.1860
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- APWD Approval withdrawn
Other devices from Abbott Laboratories
Questions
What is the PGR-EIA Monoclonal kit used for in a clinical setting?
The PGR-EIA Monoclonal is a kit designed specifically for assaying progesterone receptors in laboratory testing. It helps determine the presence and levels of progesterone receptors in tissue samples, which can be useful for evaluating hormone receptor status in conditions like breast cancer. This is performed exclusively in clinical laboratory environments.
Is the PGR-EIA Monoclonal kit intended for repeated use, or is it single-use only?
The PGR-EIA Monoclonal kit is explicitly labeled for **single-use only** in clinical laboratory settings. This ensures accuracy and reliability, as reuse could compromise sterility and test integrity. Always follow the manufacturer’s instructions for proper disposal after one use.
What storage conditions should be followed for the PGR-EIA Monoclonal kit?
While the exact storage conditions are not detailed in the provided data, the kit requires adherence to the manufacturer’s specified storage guidelines to maintain its performance. Typically, such assays demand refrigeration (e.g., 2–8°C) and protection from light until use. Always refer to the included instructions or Abbott Laboratories’ documentation for precise details.
How is the PGR-EIA Monoclonal kit regulated, and what does that mean for its use?
The PGR-EIA Monoclonal is classified as a **Class III medical device** under FDA regulation number **864.1860**, with approval granted via a **Premarket Approval (PMA)** process (PMA #P900013). This classification indicates it undergoes rigorous review for safety and effectiveness, ensuring its use in clinical laboratories is strictly governed by FDA compliance. The kit must be used as intended in accredited labs following validated protocols.