PMA P120007S003
- Device
- APTIMA HPV 16 18/45 GENOTYPE ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S003
- Product code
- OYB
- Decision date
- 2015-06-05
- Classification
- Kit, Rna Detection, Human Papillomavirus
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE. 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.
Current openFDA PMA Record#
- Device
- APTIMA HPV 16 18/45 GENOTYPE ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S003
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2015-06-05
- Decision code
- APPR
- Date received
- 2014-12-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE. 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.