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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.
 
Trade NameARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOT LABORATORIES
PMA NumberP080023
Date Received08/28/2008
Decision Date04/10/2009
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 09M-0244
Notice Date 05/27/2009
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the architect core reagent kit, architect core calibrator and architect core controls. These devices are indicated for: architect core reagent kit: the architect core assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) in human adult and pediatric serum and plasma (dipotassium edta, lithium heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. Architect core calibrator: the architect core calibrator is used for the calibration of the architect i system when the system is used for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) with the architect core reagent kit. The performance of the architect core calibrator has not been established with any other anti-hbc assays. Architect core controls: the architect core controls arc used for monitoring the performance of the architect i system when used for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) with the architect core reagent kit. The performance of the architect core controls has not been established with any other anti-hbc assays.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 
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