VIDAS FREE PSA RT ASSAY

FDA Premarket Approval P080008

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the vidasfree psa rt assay. The vidas fpsa rt is an automated quantitativetest for use on the vidas instruments, for the quantitative measurement of the free fraction ofprostate specific antigen (psa) in human serum using the elfa technique (enzyme linkedfluorescent assay). The vidas fpsa rt is intended to be used in conjunction with the vidastpsa assay in men age 50 years or older who have digital rectal examination (dre) that is notsuspicious for prostate cancer and vidas tpsa values between 4 and 10 ng/ml to determine the %free psa value. The vidas %fpsa value can be used as an aid in discriminating between prostate cancer and benign disease. Prostate biopsy is required for diagnosis of prostate cancer.

DeviceVIDAS FREE PSA RT ASSAY
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantBioMerieux, Inc.
Date Received2008-03-21
Decision Date2009-10-08
Notice Date2009-11-05
PMAP080008
SupplementS
Product CodeMTG 
Docket Number09M-0536
Advisory CommitteeImmunology
Expedited ReviewNo
Combination Product No
Applicant Address bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P080008Original Filing
S002 2012-10-11 Real-time Process
S001 2012-01-09 30-day Notice

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.