PMA P100039S001

Device

ADVIA CENTAUR ANTI-HBS2 ASSAY

Applicant

Siemens Healthcare Diagnostics, Inc.

PMA number

P100039

Supplement

S001

Product code

LOM

Decision date

2013-10-03

Classification

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

Generic name

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Approval order statement

APPROVAL FOR THE ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND ADVIACENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL FOR USE ON THE ADVIA CENTAUR CP INSTRUMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIALAND IS INDICATED FOR: ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY - THE ADVIA CENTAUR ANTI-HBS2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA (EDT A, LITHIUM-HEPARINIZED, OR SODIUM-HEPARINIZED) AND NEONATAL SAMPLES USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALSDISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THIS ASSAY HAS NOT BEEN FDA-CLEARED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL - FOR IN VITRO. DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS2 ASSAY ON THE ADVIACENTAUR SYSTEMS. THE PERFORMANCE OF THE ANTI-HBS2 QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.

Summary

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