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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
Abbott Laboratories
100 abbott park rd.
ap5n-2, dept. 09vb
abbott park, IL 60064-3500
PMA NumberP060035
Date Received12/01/2006
Decision Date11/06/2007
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0447
Notice Date 11/19/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ARCHITECT CORE-M REAGENT KITARCHITECT CORE-M CALIBRATORS ANDARCHITECT CORE-M CONTROLS. THE DEVICES IS INDICTED FOR: THE ARCHITECT CORE-M ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM OR PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. A TEST FOR IGM ANTI-HBC IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE ARCHITECT CORE-M CALIBRATORS ARE USED FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) USING THE ARCHITECT CORE-M REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE-M CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER IGM ANTI-HBC ASSAYS. THE ARCHITECT CORE-M CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN ADULT SERUM AND PLASMA WHEN USING THE ARCHITECT CORE-M REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE-M CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER IGM ANTI-HBC ASSAYS.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 
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