DIMENSION TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S002 · decided 2002-09-10
Approval details
- PMA number
- P000021
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION TPSA FLEX REAGENT CARTRIDGE
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2002-03-26
- Decision date
- 2002-09-10
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR DESIGN CHANGES. THE DESIGN CHANGES INCLUDE MODIFICATION OF THE ASSAY RESPONSE TO PROVIDE EQUIVALENT RESULTS FOR SAMPLES WITH VARYING MIXTURES OF FREE PSA AND PSA-ACT AND OPTIMIZATION OF THE METHOD DESIGN TO MINIMIZE METHOD RESPONSE TO HUMAN ANTI-MURINE IMMUNOGLOBULIN ANTIBODIES AND HUMAN ANTI-BOVINE IMMUNOGLOBULIN ANTIBODIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIMENSION TPSA FLEX REAGENT CARTRIDGE AND IS INDICATED FOR: THE TPSA METHOD FOR THE DIMENSION CL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.