• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
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 NumberP060012
Date Received03/24/2006
Decision Date09/08/2006
Withdrawal Date 11/15/2013
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0153
Notice Date 04/19/2007
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 axsym core 2. 0 and axsym core 2. 0 controls. This device is indicated for: the axsym core 2. 0 is a microparticle enzyme immunoassay (meia) intended for the qualitative detection of total antibodies (igg and igm) to hepatitis b virus core antigen (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 containing lithium heparin). The assay is used 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. The the axsym core 2. 0 controls are used for monitoring the performance of the axsym system (reagent and instrument) when used for the qualitative detection of total antibodies to hepatitis b virus core antigen (anti hbc) when using the axsym core 2. 0 reagent kit. The performance of the axsym core 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 S008 S009