Abbott IMX PSA
by Abbott Laboratories PMA
Active
PMA P910007
Overview
This device is a Total, Prostate Specific Antigen (Noncomplexed & Complexed) Immunoassay System for the detection of prostate cancer. It quantifies both free and bound PSA levels in serum or plasma, aiding in the evaluation of prostate health and the monitoring of prostate cancer progression or recurrence.
The Abbott IMX PSA is intended for use in clinical laboratories and is supplied as a reagent kit for in vitro diagnostic testing. It is a Class III device under FDA regulations, with FDA_PMA authorization (PMA Number: P910007). The system requires proper storage at controlled temperatures and adheres to standard laboratory protocols for immunoassay procedures, ensuring accurate and reliable results for diagnostic purposes.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP910007 | Date25 Sep 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Abbott Imx(R) Psa*
- Trade Name
- Axsym Total Psa & Architect Total Psa
- Generic Name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- PMA Number
- FDA Product Code
- MTF
- Device Class
- Class III
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
Other devices from Abbott Laboratories
Questions
What clinical purpose does the Abbott IMX PSA system serve in prostate health evaluation?
The Abbott IMX PSA system quantifies both free and bound (complexed) prostate-specific antigen (PSA) levels in serum or plasma. This helps clinicians evaluate prostate health, assess the risk of prostate cancer, and monitor progression or recurrence of the disease by providing total PSA measurements.
Is the Abbott IMX PSA system designed for single-use or repeated testing in a lab setting?
The device is supplied as a reagent kit intended for use in clinical laboratories, meaning it is designed for repeated testing within a controlled lab environment. Each kit contains materials for multiple assays, but individual components may be single-use depending on the specific protocol.
What storage conditions are required for the Abbott IMX PSA reagent kit?
The Abbott IMX PSA system requires proper storage at controlled temperatures to maintain accuracy and reliability. While exact temperature ranges are not specified, standard laboratory protocols for immunoassay reagents should be followed, typically involving refrigeration or room-temperature storage as per manufacturer guidelines.
How does the regulatory pathway for this device differ from other immunoassay systems?
This device is classified as a Class III medical device under FDA regulations, requiring a Premarket Approval (PMA) application due to its role in diagnosing prostate cancer—a high-risk condition. The PMA pathway ensures rigorous review of safety and effectiveness before market authorization, unlike less stringent pathways for lower-risk devices.