ST AIA-PACK PA

Prostate-specific Antigen (psa) For Management Of Prostate Cancers

FDA Premarket Approval P910065 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for design changes to include reduction of the incubation time from 40 to 10 minutes, change in the conjugate diluent, decrease in alp activity and change in packaging size from 200 tests to 100 tests per box. The device, as modified, will be marketed under the trade name st aia-pack pa and is indicated for: st aia-pack pa is designed for in vitro diagnostic use only for the quantitative measurement of prostate specific antigen (psa) in human serum on tosoh aia nex*ia and tosoh aia-600 ii analyzers. This device is indicated for the measurement of serum psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer (cap) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of psa in human serum to be used as an aid in the management of patients with prostatic cancer.

DeviceST AIA-PACK PA
Classification NameProstate-specific Antigen (psa) For Management Of Prostate Cancers
Generic NameProstate-specific Antigen (psa) For Management Of Prostate Cancers
ApplicantTOSOH BIOSCIENCE, INC.
Date Received2003-06-04
Decision Date2003-08-12
PMAP910065
SupplementS004
Product CodeLTJ
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address TOSOH BIOSCIENCE, INC. 6000 Shoreline Court suite 101 south San Francisco, CA 94080

Supplemental Filings

Supplement NumberDateSupplement Type
P910065Original Filing
S009 2019-05-20 Special (immediate Track)
S008 2011-03-30 Normal 180 Day Track
S007 2009-04-24 Normal 180 Day Track
S006 2005-06-06 Normal 180 Day Track
S005 2004-04-07 Normal 180 Day Track
S004 2003-06-04 Normal 180 Day Track
S003 2002-01-09 Normal 180 Day Track
S002 1999-12-16 Normal 180 Day Track
S001 1999-03-25 Panel Track

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