IMMULITE FPSA ASSAY

Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Premarket Approval P060005 S008

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 eliminating the test redundancy by using only the bioradlyphocheck immunoassay plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of immulite afp, free psa, and psa/3rd generation psa assay performance.

DeviceIMMULITE FPSA ASSAY
Classification NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
Date Received2012-05-30
Decision Date2012-11-08
PMAP060005
SupplementS008
Product CodeMTG
Advisory CommitteeImmunology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED glyn Rhonwy. Llanberis caernarfon gwynedd, Ll55 4EL

Supplemental Filings

Supplement NumberDateSupplement Type
P060005Original Filing
S016 2022-09-15 30-day Notice
S015
S014 2022-02-28 30-day Notice
S013 2021-04-14 30-day Notice
S012 2020-08-12 30-day Notice
S011 2020-07-23 30-day Notice
S010 2019-11-25 30-day Notice
S009 2018-09-28 Real-time Process
S008 2012-05-30 135 Review Track For 30-day Notice
S007 2011-12-19 135 Review Track For 30-day Notice
S006 2011-08-16 30-day Notice
S005 2011-08-08 30-day Notice
S004 2011-02-18 Real-time Process
S003 2009-11-02 Normal 180 Day Track No User Fee
S002
S001 2008-11-10 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00630414977478 P060005 001
00630414971575 P060005 001

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