IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

FDA premarket approval P060005 · decided 2007-05-11

Approval details

PMA number

P060005

Trade name

IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

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

Days to decision

451 days

Decision code

APPR

Product code

MTG

Advisory committee

Immunology

Expedited review

No

Location

Gwynedd Ll55

Statement

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). MEASUREME