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U.S. Department of Health and Human Services

Product Classification

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Device prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
Regulation Description Gene expression profiling test system for breast cancer prognosis.
Definition Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer.
Physical State Capture antidbody, DNA-labeled antibody and PCR reagents. Software
Technical Method Uses Immuno-PCR technology. Ultrasensitive levels (picograms/ml concentration) of total prostate specific antigen are captured in a sandwich immunoassay using DNA-labeled antibody. The sandwich is detected by Polymerase Chain Reaction exponential amplification. Rate of increase in PSA concentration over a time period is determined by computer software.
Target Area Serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOWM
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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