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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.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
PMA NumberP060009
Date Received03/10/2006
Decision Date08/25/2006
Withdrawal Date 11/15/2013
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0160
Notice Date 04/30/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the abbott axsym core-m 2. 0 and axsym core-m 2. 0 controls. These devices are indicated for: the axsym core-m 2. 0 is a microparticle enzyme immunoassay (meia) intended for the in vitro qualitative detection of igm antibody to hepatitis b virus core antigen (igm anti-hbc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium edta, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes). The assay is used 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 axsym core-m 2. 0 controls are used for monitoring the performance of the axsym system (reagent and instrument) when used for the qualitative detection of igm antibody to hepatitis b virus core antigen (igm anti hbc) when using the axsym core-m 2. 0 reagent pack. The performance of the axsym core-m 2. 0 controls has not been established with any other anti-hbc assays.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007