FDA.reportPublic FDA data

PMA P100042S001

Device
APTIMA HPV ASSAY
Applicant
Gen-Probe Incorporated
PMA number
P100042
Supplement
S001
Product code
OYB
Decision date
2013-07-15
Classification
Kit, Rna Detection, Human Papillomavirus
Generic name
Kit, rna detection, human papillomavirus
Approval order statement
APPROVAL FOR THE ADDITION OF THE PANTHER SYSTEM TO THE APTIMA® HPV ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV ASSAY. THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18, 31, 33, 35, 39, 45, 51, 52,56, 58, 59, 66, AND 68. THE APTIMA HPV ASSAY DOES NOT DISCRIMINATE BETWEEN THE 14 HIGH-RISK TYPES. CERVICAL SPECIMENS COLLECTED IN THINPREP PAP TEST VIALS CONTAINING PRESESRVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM. THE USE OF THE TEST IS INDICATED: 1) TO SCREEN WOMEN 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY; AND 2) IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV ASSAY CAN BE USED WITH CERVICAL CYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIANS ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT. BROOM-TYPE DEVICE (E.G., WALLACH PIPETTE) OR ENDOCERVICAL BRUSH/SPATULA.

Current openFDA PMA Record#

Device
APTIMA HPV ASSAY
Applicant
Gen-Probe Incorporated
PMA number
P100042
Supplement
S001
Product code
OYB
Generic name
Kit, rna detection, human papillomavirus
Decision date
2013-07-15
Decision code
APPR
Date received
2012-10-04
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE ADDITION OF THE PANTHER SYSTEM TO THE APTIMA® HPV ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV ASSAY. THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18, 31, 33, 35, 39, 45, 51, 52,56, 58, 59, 66, AND 68. THE APTIMA HPV ASSAY DOES NOT DISCRIMINATE BETWEEN THE 14 HIGH-RISK TYPES. CERVICAL SPECIMENS COLLECTED IN THINPREP PAP TEST VIALS CONTAINING PRESESRVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM. THE USE OF THE TEST IS INDICATED: 1) TO SCREEN WOMEN 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY; AND 2) IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV ASSAY CAN BE USED WITH CERVICAL CYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIANS ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT. BROOM-TYPE DEVICE (E.G., WALLACH PIPETTE) OR ENDOCERVICAL BRUSH/SPATULA.