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.

The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [
Access Hybritech p2PSA - B03704

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen, using a chemiluminescent immunoassay method.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OYA

Device Name: P2psa

Device Class: 3

Physical State: Reagent packs, calibrators, controls, substrate and wash buffer

Definition: Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)

Submission Type ID: 2

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A two-site immunoenzymatic assay using paramagnetic particles coated with a mouse monoclonal anti-[-2]proPSA antibody to capture the [-2]proPSA and mouse monoclonal anti-PSA alkaline phosphatase conjugate that reacts with a chemiluminescent substrate to generate light. Light production is measured with a luminometer.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: peripheral blood

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: H628B037041

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A