Identity
- Trade Name
- CIBA CORNING ACS PSA IMMUNOASSAY FDA PMA
- Generic Name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS FDA PMA
Identifiers
- PMA Number
- P920030 FDA PMA
- FDA Product Code
- LTJ FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.6010 FDA PMA
- Regulation Number
- 866.6010 FDA PMA
- Advisory Committee
- Immunology FDA PMA
- FDA Decision
- APWD FDA PMA
This device is an immunoassay system for measuring Prostate-Specific Antigen (PSA) in serum or plasma, used for the management of prostate cancer. Classified under the nomenclature for Prostate-Specific Antigen (PSA) assays, it quantifies PSA levels to aid in diagnostic and monitoring processes for prostate-related conditions.
The Ciba Corning ACS PSA Immunoassay is designed for in vitro diagnostic use in clinical laboratory settings. Supplied as a single-use reagent kit, it requires automated immunoassay analyzers for operation and is intended for professional healthcare use only. Regulated under FDA Premarket Approval (PMA P920030), it adheres to regulatory standards for Class II devices under the classification LTJ (Prostate-Specific Antigen Assays)
Frequently asked questions
What clinical conditions is this immunoassay primarily used to monitor or diagnose, and how does it help in those contexts?
The Ciba Corning ACS PSA Immunoassay is designed to measure Prostate-Specific Antigen (PSA) levels in serum or plasma, which aids in the management and monitoring of prostate cancer. Elevated PSA levels can indicate the presence of prostate cancer or other prostate-related conditions, making this assay useful for diagnostic evaluation and ongoing monitoring of treatment efficacy or disease progression in patients.
Is this device intended for single-use or repeated use, and what type of equipment is required to operate it?
This device is supplied as a single-use reagent kit, meaning each kit is intended for one use only. It requires automated immunoassay analyzers for operation, making it suitable only for professional healthcare settings, such as clinical laboratories, where such equipment is available.
How is the regulatory approval status of this device determined, and what does that mean for its use in clinical settings?
The Ciba Corning ACS PSA Immunoassay holds FDA Premarket Approval (PMA P920030), which means it has undergone rigorous review by the FDA to ensure its safety, effectiveness, and performance for its intended use. This approval allows it to be legally used in clinical laboratories in the U.S. for measuring PSA levels, adhering to regulatory standards for Class II devices under the product code LTJ.
What type of sample can be tested with this immunoassay, and is there any special handling required for the sample?
This immunoassay is specifically designed to measure PSA in serum or plasma samples. While the device itself does not require special handling beyond standard laboratory protocols, the sample must be properly collected, processed, and stored according to clinical laboratory guidelines to ensure accurate and reliable results.
What does the advisory committee classification (Immunology) indicate about the device’s role in clinical practice?
The advisory committee classification under Immunology (IM) reflects that this device is categorized within the broader field of immunological assays. This classification highlights its role in measuring specific biomarkers (PSA) that are critical for diagnosing and monitoring conditions related to the immune system or specific diseases, such as prostate cancer, where PSA is a key diagnostic marker.
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 | P920030 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA PMA P920030 24 fields · synced Oct 6, 2026