PMA P100042S007

Device: APTIMA HPV ASSAY
Applicant: Gen-Probe Incorporated
PMA number: P100042
Supplement: S007
Product code: OYB
Decision date: 2015-11-24
Classification: Kit, Rna Detection, Human Papillomavirus
Generic name: Kit, rna detection, human papillomavirus
Approval order statement: APPROVAL FOR A CHANGE TO THE APTIMA HPV ASSAY SOFTWARE FROM VERSION 4.2.0 TO VERSION 4.2.1. THIS CHANGE IS BEING IMPLEMENTED TO REDUCE THE PROBE REAGENT MIXING SPEED IN THE HYBRIDIZATION PROTECTION ASSAY (HPA) INCUBATOR FROM 14 HZ TO 5 HZ ON THE TIGRIS SYSTEM. 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.

Current openFDA PMA Record#

Device: APTIMA HPV ASSAY
Applicant: Gen-Probe Incorporated
PMA number: P100042
Supplement: S007
Product code: OYB
Generic name: Kit, rna detection, human papillomavirus
Decision date: 2015-11-24
Decision code: APPR
Date received: 2015-08-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE APTIMA HPV ASSAY SOFTWARE FROM VERSION 4.2.0 TO VERSION 4.2.1. THIS CHANGE IS BEING IMPLEMENTED TO REDUCE THE PROBE REAGENT MIXING SPEED IN THE HYBRIDIZATION PROTECTION ASSAY (HPA) INCUBATOR FROM 14 HZ TO 5 HZ ON THE TIGRIS SYSTEM. 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.