Kit, Rna Detection, Human Papillomavirus
Basic Information
- Device Name
- Kit, Rna Detection, Human Papillomavirus
- Trade Name
- APTIMA HPV 16 18/45 GENOTYPE ASSAY
- PMA Number
- P120007
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- OYB
- Generic Name
- Kit, rna detection, human papillomavirus
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 6, 2013
- Date Received
- May 15, 2013
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF THE PANTHER SYSTEM TO THE APTIMA® HPV 16 18/45 GENOTYPE ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV 16 18/45 GENOTYPE ASSAY. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) OF HUMAN PAPILLOMAVIRUS (HPV) TYPES 16, 18, AND 45 IN CERVICAL SPECIMENS FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN DIFFERENTIATE HPV 16 FROM HPV 18 AND/OR HPV 45, BUT DOES NOT DIFFERENTIATE BETWEEN HPV 18 AND HPV 45. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV 16 18/45 GENOTYPE ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM. FOR FURTHER INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OYB | Kit, Rna Detection, Human Papillomavirus | FDA class 3 | Unknown |