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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-M REAGENT KIT/CALIBRATORS/CONTROLS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the architect core-m reagent kit architect core-m calibrators and architect 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
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 
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