DIGENE HYBRID CAPTURE 2 HPV DNA TEST
FDA premarket approval P890064/S015 · decided 2004-07-29
Approval details
- PMA number
- P890064
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIGENE HYBRID CAPTURE 2 HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2004-05-28
- Decision date
- 2004-07-29
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR REVISIONS TO THE ASSAY'S LABELING PERFORMANCE CHARACTERISTICS SECTION. THE CHANGE INVOLVES MOVING THE SECTION "RELATIVE FALSE-POSITIVE AND FALSE-NEGATIVE RATE" FROM THE LABELING'S CLINICAL PERFORMANCE SECTION TO THE ANALYTICAL SECTION WITH NARRATIVE REVISIONS. THE NEW SECTION IS ENTITLED "EXTERNAL STUDY USING CLINICAL SPECIMENS." A NEW NOTE HAS BEEN ADDED TO THE CURRENT LABELING'S TABLE 10 REFERENCED TO SNIJDERS, PJF, VAN DE BRULE, AJC, AND MEIJER, CJLM, "THE CLINICAL RELEVANCE OF H
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