DIMENSION FPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P020027/S001 · decided 2003-10-10
Approval details
- PMA number
- P020027
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIMENSION FPSA FLEX REAGENT CARTRIDGE
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2003-09-29
- Decision date
- 2003-10-10
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL OF THE FOLLOWING MODIFICATIONS TO THE DIMENSION FPSA FLEX REAGENT CARTRIDGE: 1) ADDITION OF LITHIUM HEPARIN PLASMA AS A SAMPLE TYPE IN THE INTENDED USE AND THE PACKAGE LABELING. 2) ADDITION OF THE DISCLAIMER "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS" TO THE RESULTS SECTION OF THE PACKAGE LABELING. 3) CORRECTION OF THE UNITS FOR IGG IN THE PACKAGE LABELING FROM 6 G/ML TO 6 G/DL. THE DEVIC
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