The Access Hybritech p2PSA Calibrators are intended to calibrate the Access Hybritech p2PSA assay as an aid in distinguishing prostate cancer from benign prostatic conditions using human serum on the Access Immunoassay Systems.
Access Hybritech p2PSA Calibrators - B03705
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: H628B037051
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