Identity
- Trade Name
- IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS FDA PMA
- Generic Name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions FDA PMA
Identifiers
- PMA Number
- P060005 FDA PMA
- FDA Product Code
- MTG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Immunology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Immulite Free PSA Assay is an in vitro diagnostic test designed for the quantitative measurement of free prostate-specific antigen (PSA) in human serum. Free PSA refers to the unbound form of PSA, not complexed with proteins such as alpha 1-antichymotrypsin, and is used alongside total PSA measurements to aid in distinguishing prostate cancer from benign conditions in men aged 50 or older with specific PSA ranges and non-suspicious digital rectal exam findings.
This assay is intended for use with the Immulite 1000 or Immulite 2000 analyzers and requires serum samples collected in serum glass, plastic, or gel separator tubes. It is supplied as a single-use reagent kit and is classified as a Class III medical device under FDA regulations, with approval granted under PMA number P060005. The device is not intended for MRI use and must be stored according to manufacturer instructions to maintain performance integrity.
Frequently asked questions
What is the primary clinical purpose of the Immulite Free PSA Assay, and how does it differ from total PSA testing?
The Immulite Free PSA Assay measures the unbound (free) form of prostate-specific antigen (PSA) in human serum to help distinguish prostate cancer from benign conditions in men aged 50 or older. Unlike total PSA, which measures all PSA forms, free PSA is used alongside total PSA to calculate the percent free PSA ratio. This ratio aids clinicians in evaluating men with total PSA levels between 4 and 10 ng/mL and non-suspicious digital rectal exam findings, as it can improve diagnostic accuracy for prostate cancer. A prostate biopsy remains necessary for definitive diagnosis.
Which analyzers are compatible with the Immulite Free PSA Assay, and what sample types can be used?
The Immulite Free PSA Assay is designed exclusively for use with the Immulite 1000 or Immulite 2000 analyzers. It accepts serum samples collected in serum glass tubes, plastic tubes, or gel separator tubes, ensuring flexibility in sample collection while maintaining assay compatibility.
Is the Immulite Free PSA Assay single-use, and if so, how should it be stored to preserve performance?
Yes, the Immulite Free PSA Assay is supplied as a single-use reagent kit, meaning each kit is intended for one-time use only. To maintain performance integrity, it must be stored according to the manufacturer’s instructions, which likely include specific temperature and handling guidelines to prevent degradation or contamination.
What regulatory pathway was followed for the approval of this device, and what class designation does it hold?
The Immulite Free PSA Assay was approved under the FDA’s Premarket Approval (PMA) pathway, with PMA number P060005. It is classified as a Class III medical device, reflecting its role in diagnosing prostate cancer—a high-risk condition requiring stringent regulatory oversight.
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 | P060005 | Class III | Active |
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Manufacturer
- Manufacturer
- Siemens Medical Solutions Diagnostics Limited
Sources (1)
- FDA PMA P060005 24 fields · synced Sep 18, 2026