IsoPSA Assay
by Cleveland Diagnostics, Inc.
PMA P200048
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP200048 | Date28 Nov 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- PMA Number
- FDA Product Code
- QRF
- Device Class
- Class III
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The IsoPSA Assay is an in vitro test system classified as a multi-analyte diagnostic device with algorithmic analysis. It combines total Prostate-Specific Antigen (PSA) and free PSA measurements from heparinized plasma into a single numerical index to aid in identifying high-grade prostate cancer (Grade Group ≥ 2; Gleason score ≥ 7) in men aged 50 or older with PSA levels between 4.0 and 10.0 ng/mL.
This device is intended for use alongside clinical judgment and other patient data to support biopsy decision-making in men under consideration for prostate biopsy. Supplied as a kit for laboratory use, it requires partitioned heparinized plasma samples processed on the Elecsys platform (Roche Diagnostics). The assay is approved under FDA PMA (P200048) and falls under Class III regulatory classification (QRF product code).
Other devices from Cleveland Diagnostics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What specific patient population is the IsoPSA Assay designed to assist in evaluating for high-grade prostate cancer?
The IsoPSA Assay is designed for men aged 50 or older who have total Prostate-Specific Antigen (PSA) levels between 4.0 and 10.0 ng/mL and are under consideration for a prostate biopsy. It combines total PSA and free PSA measurements to generate a numerical index that aids in identifying high-grade prostate cancer (Grade Group ≥ 2 or Gleason score ≥ 7) as part of clinical decision-making.
How is the IsoPSA Assay supplied and what type of sample is required for testing?
The IsoPSA Assay is supplied as a laboratory kit and requires partitioned heparinized plasma samples. These samples must be processed on the Elecsys platform by Roche Diagnostics to generate the total PSA and free PSA measurements used in the algorithmic analysis.
Is the IsoPSA Assay intended for standalone use, or must it be used alongside other clinical information?
The IsoPSA Assay is explicitly intended for use alongside clinical judgment and other patient data. It is not meant for standalone use but rather as an additional tool to support biopsy decision-making in men being considered for prostate biopsy, based on current standard of care.
What regulatory pathway was followed for the approval of the IsoPSA Assay, and what class does it fall under?
The IsoPSA Assay was approved through the FDA’s Premarket Approval (PMA) pathway under PMA number P200048. It is classified as a Class III medical device, which is the highest regulatory classification for devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.
Does the IsoPSA Assay provide a definitive diagnosis of prostate cancer, or is it used to guide further diagnostic steps?
The IsoPSA Assay does not provide a definitive diagnosis of prostate cancer. Instead, it generates a numerical index to aid in identifying men at higher risk of high-grade prostate cancer (Grade Group ≥ 2 or Gleason score ≥ 7), helping clinicians decide whether a prostate biopsy is warranted. Biopsy remains the required next step for confirming cancer diagnosis.