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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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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