PMA P890064S015

Device: DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S015
Product code: MAQ
Decision date: 2004-07-29
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: APPROVAL FOR REVISIONS TO THE ASSAY'S LABELING PERFORMANCE CHARACTERISTICS SECTION. THE CHANGE INVOLVES MOVING THE SECTION "RELATIVE FALSE-POSITIVE AND FALSE-NEGATIVE RATE" FROM THE LABELING'S CLINICAL PERFORMANCE SECTION TO THE ANALYTICAL SECTION WITH NARRATIVE REVISIONS. THE NEW SECTION IS ENTITLED "EXTERNAL STUDY USING CLINICAL SPECIMENS." A NEW NOTE HAS BEEN ADDED TO THE CURRENT LABELING'S TABLE 10 REFERENCED TO SNIJDERS, PJF, VAN DE BRULE, AJC, AND MEIJER, CJLM, "THE CLINICAL RELEVANCE OF HUMAN PAPILLOMAVIRUS TESTING: RELATIONSHIP BETWEEN ANALYTICAL AND CLINICAL SENSITIVITY". J PATHOL 2003; 201: 1-6.

Current openFDA PMA Record#

Device: DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Applicant: Qiagen Gaithersburg, Inc.
PMA number: P890064
Supplement: S015
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2004-07-29
Decision code: APPR
Date received: 2004-05-28
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISIONS TO THE ASSAY'S LABELING PERFORMANCE CHARACTERISTICS SECTION. THE CHANGE INVOLVES MOVING THE SECTION "RELATIVE FALSE-POSITIVE AND FALSE-NEGATIVE RATE" FROM THE LABELING'S CLINICAL PERFORMANCE SECTION TO THE ANALYTICAL SECTION WITH NARRATIVE REVISIONS. THE NEW SECTION IS ENTITLED "EXTERNAL STUDY USING CLINICAL SPECIMENS." A NEW NOTE HAS BEEN ADDED TO THE CURRENT LABELING'S TABLE 10 REFERENCED TO SNIJDERS, PJF, VAN DE BRULE, AJC, AND MEIJER, CJLM, "THE CLINICAL RELEVANCE OF HUMAN PAPILLOMAVIRUS TESTING: RELATIONSHIP BETWEEN ANALYTICAL AND CLINICAL SENSITIVITY". J PATHOL 2003; 201: 1-6.