Kit, Dna Detection, Human Papillomavirus
Basic Information
- Device Name
- Kit, Dna Detection, Human Papillomavirus
- Trade Name
- COBAS HPV TEST
- PMA Number
- P100020
- Supplement Number
- S008
- Device Class
- FDA Class 3
- Product Code
- MAQ
- Generic Name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 24, 2014
- Date Received
- July 1, 2013
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 14M-0552
Advisory Committee Statement
APPROVAL FOR THE COBAS® HPV TEST. THE COBAS® HPV TEST INDICATIONS FOR USE: THE COBAS® HPV TEST IS A QUALITATIVE IN VITRO TEST FOR THE DETECTION OF HUMAN PAPILLOMAVIRUS IN CERVICAL SPECIMENS COLLECTED BY A CLINICIAN USING AN ENDOCERVICAL BRUSH/SPATULA AND PLACED IN THE THINPREP® PAP TESTTM PRESERVCYT® SOLUTION. THE TEST UTILIZES AMPLIFICATION OF TARGET DNA BY THE POLYMERASE CHAIN REACTION (PCR) AND NUCLEIC ACID HYBRIDIZATION FOR THE DETECTION OF 14 HIGH-RISK (HR) HPV TYPES IN A SINGLE ANALYSIS. THE TEST SPECIFICALLY IDENTIFIES TYPES HPV16 AND HPV18 WHILE CONCURRENTLY DETECTING THE REST OF THE HIGH RISK TYPES (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 AND 68).THE COBAS® HHPV TEST IS INDICATED:1) TO SCREEN PATIENTS 21 YEARS AND OLDER WITH ASC-US (ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE) CERVICAL CYTOLOGY TEST RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY; 2) TO BE USED IN PATIENTS PLEASE SEE APPROVAL ORDER FOR FURTHER INFORMATION.
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 |
|---|---|---|---|
| MAQ | Kit, Dna Detection, Human Papillomavirus | FDA class 3 | Unknown |