PATHVYSION HER-2 DNA PROBE KIT
FDA premarket approval P980024/S006 · decided 2012-02-27
Approval details
- PMA number
- P980024
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PATHVYSION HER-2 DNA PROBE KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2011-10-17
- Decision date
- 2012-02-27
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR MANUFACTURING PROCESS CHANGES TO THE PATHVYSION HER-2 DNA PROBE KIT, INCLUDING CHANGES ASSOCIATED WITH FISH PROBE RESTRICTION ENZYMEDIGESTED GEL ELECTROPHORESIS (DNA RESTRICTION ANALYSIS), IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR A260 ABSORBANCE READINGS, ADDITION OF AN INCOMING SCREENING TEST FOR DEXTRAN SULFATE AND REVISION TO MANUFACTURING PROCEDURE DOCUMENT FOR LSI HER-2/NEU AMINATED DNA.
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