IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

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

FDA Premarket Approval P060005

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 immulite / immulite 1000 and immulite 2000 free psa assay. These devices are indicated for: the immulite / immulite 1000 free psa assay is indicated for in vitro diagnostic use with the immulite / immulite 1000 analyzer for the quantitative measurement of free prostate-specific antigen (psa) not bound to alpha 1-antichymotrypsin or other binding proteins (uncomplexed) in human serum (including serum collected in serum glass, serum plastic an serum gel separator tubes). Measurement of free psa is used in conjunction with immulite / immulite 1000 total psa to determine a ratio of free psa to total psa (percent free psa). The percent free psa is used as an aid in discriminating prostate cancer from benign disease in men 50 years or older with immulite / immulite 1000 total psa values between 4 and 10 ng/ml and digital rectal exam (dre) findings not suspicious of cancer. Prostate biopsy is required for the diagnosis of prostate cancer. The immulite 2000 free psa assay is indicated for in vitro diagnostic use with the immulite 2000 analyzer for the quantitative measurement of free prostate-specific antigen (psa) not bound to alpha 1-antichymotrypsin or other binding proteins (uncomplexed) in human serum (including serum collected in serum glass, serum plastic an serum gel separator tubes). Measurement of free psa is used in conjunction with immulite 2000 total psa to determine a ratio of free psa to total psa (percent free psa). The percent free psa is used as an aid in discriminating prostate cancer from benign disease in men 50 years or older with immulite 2000 total psa values between 4 and 10 ng/ml and digital rectal exam (dre) findings not suspicious of cancer. Prostate biopsy is required for the diagnosis of prostate cancer.

DeviceIMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS
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 Received2006-02-14
Decision Date2007-05-11
Notice Date2007-11-09
PMAP060005
SupplementS
Product CodeMTG
Docket Number07M-0409
Advisory CommitteeImmunology
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED glyn Rhonwy. Llanberis caernarfon gwynedd, Ll55 4EL
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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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