Identity
- Trade Name
- AIA-PACK PSA FDA PMA
- Generic Name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer FDA PMA
Identifiers
- PMA Number
- P910065 FDA PMA
- FDA Product Code
- MTF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Immunology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The AIA-PACK PSA is an Immunoassay Device for the quantitative detection of total prostate-specific antigen (PSA), including both noncomplexed and complexed forms, in human serum or plasma. It is designed to aid in the detection and monitoring of prostate cancer by measuring PSA levels, a biomarker associated with prostate pathology.
This device is supplied as a single-use, in-vitro diagnostic reagent kit intended for laboratory use. It requires no special storage conditions beyond refrigeration (2–8°C) and is approved under an FDA Premarket Approval (PMA) with PMA number P910065. The kit includes all necessary components for performing the assay, adhering to regulatory standards for diagnostic accuracy and reliability.
Frequently asked questions
What clinical purpose does the AIA-PACK PSA device serve in prostate cancer management?
The AIA-PACK PSA is designed to measure total prostate-specific antigen (PSA) levels in human serum or plasma, including both noncomplexed and complexed forms. This quantitative detection aids clinicians in detecting and monitoring prostate cancer by evaluating PSA—a biomarker linked to prostate pathology—helping assess disease progression or response to treatment.
Is the AIA-PACK PSA kit reusable, or is it intended for single-use only?
The AIA-PACK PSA is explicitly supplied as a single-use immunoassay reagent kit. Each kit is intended for one assay procedure in a laboratory setting, ensuring consistency and sterility for accurate results without cross-contamination risks.
What storage conditions are required for the AIA-PACK PSA, and can it be kept at room temperature?
The device requires refrigeration between 2–8°C for storage. It does not tolerate room temperature or freezing, as this could compromise its stability or performance. Always store it in the original packaging away from direct light.
How was the AIA-PACK PSA approved by the FDA, and what does that approval cover?
The AIA-PACK PSA received FDA Premarket Approval (PMA) under PMA number P910065, indicating it meets rigorous standards for safety and effectiveness as an in-vitro diagnostic device. This approval covers its use as a quantitative immunoassay for total PSA detection in serum/plasma to aid in prostate cancer monitoring.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P910065 | Class II | Active |
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Manufacturer
- Manufacturer
- Tosoh Bioscience, Inc.
Sources (1)
- FDA PMA P910065 24 fields · synced Sep 18, 2026