This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: MONOLISA™ Anti-HBc IgM EIA
PMA Applicant: Bio-Rad Laboratories
Address: 6565 185th Ave NE, Redmond WA 98052
Approval Date: May 31, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060034a.pdf
What is it? The MONOLISA™ Anti-HBc IgM EIA is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV core antigen. Presence of the antibodies can help determine if the patient is currently or has recently been infected with HBV.
How does it work?
- The MONOLISA™ Anti-HBc IgM EIA is an enzyme immunoassay
- Patient specimens are incubated with microwells coated with anti-human IgM
- If IgM antibodies to HBc are present in a specimen or control, they bind to the antibody
- The anti-human conjugate is then added to the microwells and allowed to incubate and washed
- If a sample contains anti-HBc IgM, the bound enzyme (HRP) causes the colorless tetramethylbenzidine,
solution to change to blue
When is it used? This lab test is used to determine if the person is, or has been recently infected with HBV.
What will it accomplish? Results of this lab test may help a doctor determine:
- the stage of HBV infection
- an appropriate course of treatment, depending on the stage of HBV infection
When should it not be used? This lab test can only be used if ordered by a physician. This test is a prescription device. This test has not been FDA licensed for screening blood donors. There are no other known patient exclusions.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060034