Immunocytochemical Assay to Detect Progesterone
by Abbott Laboratories PMA
Withdrawn
PMA P920006
Overview
This device is an immunocytochemical assay kit designed to detect progesterone receptor expression in tissue samples. Classified as a Kit, Assay, Progesterone Receptor under FDA nomenclature (device class III, regulation number 864.1860), it provides qualitative results for assessing hormone receptor status in clinical pathology, particularly in hematology and oncology settings.
The kit is supplied as a single-use diagnostic tool, intended for use in laboratory settings by trained personnel. Sterility is not specified, but it must be handled according to standard laboratory protocols for immunocytochemical assays. No MRI safety information is provided, and the device requires proper storage as outlined in the accompanying instructions. Approval for this assay was granted under FDA_PMA (PMA number P920006) and is governed by regulatory requirements for class III devices.
Regulatory status
Withdrawn since 26 Sep 1995. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP920006 | Date26 Sep 1995 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Specification
- 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
- APWD Approval withdrawn
Other devices from Abbott Laboratories
Questions
What clinical specialties primarily use this immunocytochemical assay for progesterone detection, and why is it relevant to those fields?
This assay is primarily used in hematology and oncology settings, where assessing progesterone receptor expression helps guide treatment decisions for hormone-sensitive cancers, such as breast cancer. Clinicians rely on these results to determine whether patients may benefit from hormone therapy or targeted interventions.
Is this assay intended for single-use only, and how should it be stored to maintain its integrity?
Yes, this assay is designed for single-use only in laboratory settings. Storage instructions are detailed in the accompanying documentation, but generally, it should be kept according to standard immunocytochemical assay protocols—typically at controlled room temperature or refrigerated, away from direct light and moisture, until use.
What regulatory pathway was followed for FDA approval of this device, and what does that mean for its use in clinical practice?
This assay was approved through the FDA’s Premarket Approval (PMA) pathway, specifically under PMA number P920006, due to its classification as a class III device under regulation number 864.1860. This means it underwent rigorous review by the FDA’s Clinical Chemistry Advisory Committee (CH) to ensure safety and effectiveness before clinical use, ensuring it meets strict standards for diagnostic accuracy in hormone receptor testing.
Does this assay require special handling for sterility, or can it be used in non-sterile laboratory environments?
The assay does not specify sterility requirements, but it must be handled following standard laboratory protocols for immunocytochemical assays to prevent contamination. Since it’s intended for use in clinical pathology labs, trained personnel should adhere to best practices for sample preparation and assay execution, even if the kit itself isn’t sterile.