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.
| Device | IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS |
| Classification Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED |
| Date Received | 2006-02-14 |
| Decision Date | 2007-05-11 |
| Notice Date | 2007-11-09 |
| PMA | P060005 |
| Supplement | S |
| Product Code | MTG |
| Docket Number | 07M-0409 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| 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 Number | Date | Supplement Type |
|---|
| P060005 | | Original 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