Access Hybritech p2PSA B03704

GUDID H628B037041

The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2]proPSA antigen, an isoform of free PSA, in human serum using the Access Immunoassay Systems. Access Hybritech p2PSA is intended to be used in combination with Access Hybritech (total) PSA and Access Hybritech free PSA to calculate the Beckman Coulter Prostate Health Index (phi), an In Vitro Diagnostic Multivariate Index Assay (IVDMIA). Beckman Coulter phi as calculated using the Access Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4.0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.

Beckman Coulter, Inc.

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: H628B037041
• NIH Device Record Key: 0ad76e29-3dd4-4db9-8b9f-5578d12f6b46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Hybritech p2PSA
• Version Model Number: B03704
• Catalog Number: B03704
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H628B037041 [Primary]

FDA Product Code

• OYA: P2psa

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2014-09-16

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