Abbott ER-ICA Monoclonal Kit, Assay, Estrogen Receptor
by Abbott Laboratories PMA
Withdrawn
PMA P880026
Overview
This device is a Kit, Assay, Estrogen Receptor (OpenFDA: LPJ), classified under device class 3 (regulation number 864.1860) and filed under Clinical Chemistry (advisory committee: CH). It is designed for the qualitative detection of estrogen receptor proteins in tissue samples, aiding in the assessment of hormone receptor status in breast cancer diagnostics.
The Abbott ER-ICA Monoclonal Kit is supplied as a single-use diagnostic assay and requires laboratory processing. It is intended for use in sterile settings, such as pathology labs, and must be stored under specified conditions as outlined in the accompanying instructions. Authorized under FDA_PMA (P880026), this device adheres to regulatory standards for in vitro diagnostic use.
Regulatory status
Withdrawn since 30 Sep 1988. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP880026 | Date30 Sep 1988 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Specification
- Full name
- Abbott Er-Ica Monoclonal
- Generic Name
- KIT, ASSAY, ESTROGEN RECEPTOR
- PMA Number
- FDA Product Code
- LPJ
- Regulation
- 21 CFR Part 864.1860
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- APWD Approval withdrawn
Other devices from Abbott Laboratories
Questions
What is the Abbott ER-ICA Monoclonal Kit used for in clinical practice?
The Abbott ER-ICA Monoclonal Kit is designed for the qualitative detection of estrogen receptor proteins in tissue samples, helping clinicians assess hormone receptor status in breast cancer diagnostics. This aids in determining appropriate treatment pathways, such as hormone therapy, for patients.
Is the Abbott ER-ICA Monoclonal Kit intended for single-use or repeated use?
The kit is explicitly labeled as a **single-use diagnostic assay**, meaning each kit is intended for one-time use in a single test procedure. This ensures accuracy and sterility, as it is meant for use in sterile laboratory settings like pathology labs.
How should the Abbott ER-ICA Monoclonal Kit be stored, and what are the key handling requirements?
While the exact storage conditions are detailed in the accompanying instructions, the kit is designed for **sterile** laboratory use, implying it must be stored under controlled conditions to maintain integrity. Proper storage is critical to preserve the assay’s performance, particularly since it is a single-use diagnostic tool requiring careful handling to prevent contamination or degradation.
What regulatory pathway does the Abbott ER-ICA Monoclonal Kit follow, and what does this mean for its use?
The kit is authorized under **FDA_PMA (P880026)**, which means it has undergone a **Premarket Approval** process—a rigorous review for high-risk medical devices like Class 3 assays. This ensures the device meets strict safety and effectiveness standards before being used in clinical settings for estrogen receptor testing in breast cancer diagnostics.