Kit, Rna Detection, Human Papillomavirus
Basic Information
- Device Name
- Kit, Rna Detection, Human Papillomavirus
- Trade Name
- APTIMA HPV ASSAY
- PMA Number
- P100042
- Supplement Number
- S007
- 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 24, 2015
- Date Received
- August 12, 2015
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
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 |