HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST
FDA premarket approval P890064/S013 · decided 2003-11-07
Approval details
- PMA number
- P890064
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2003-10-01
- Decision date
- 2003-11-07
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR: 1) MODIFICATION OF HYBRIDIZATION PROCEDURAL STEPS AND SEQUENCE; THIS MODIFICATION ENTAILS REVERSING THE ADDITION ORDER OF THE HPV RNA PROBES AND DENATURED SPECIMEN WITH NO CHANGE IN PROBE OR SPECIMEN VOLUME. AN ADDITIONAL 10 MINUTE INCUBATION PERIOD AT ROOM TEMPERATURE (15 DEGREES C TO 30 DEGREES C) WAS ADDED AFTER REMOVAL OF THE SPECIMEN FROM THE 65 += 2 DEGREES C, 60 MINUTES HYBRIDIZATION INCUBATION STEP. 2) ADDITION OF AN EQUIVOCAL RESULT ZONE, WHICH REQUIRES REPEATING SPECIMENS
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