This is a brief overview of information related to FDA’s approval of an Evaluation of Automatic Class III Designation to market this device.
Product Name: Wako LBA AFP-L3
Manufacturer: Wako Chemicals USA, Inc.
Address: 1600 Bellwood Road, Richmond, VA 23237
Approval Date: May 19, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k041847.pdf
What is it? Wako LBA AFP-L3 is a lab test that helps determine the risk of developing liver cancer in patients with chronic liver disease (CLD). This lab test measures how much the L3 form of AFP (alpha fetoprotein) a patient has in their blood sample. The test also measures the total amount of AFP. The test calculates the L3 as a percent of total AFP (AFP-L3%). Elevated levels of AFP-L3 in chronic liver disease patients are associated with the risk of developing liver cancer.
How does it work?
- A sample of blood is drawn from the patient and added to chemicals in the Wako LBA AFP-L3 test.
- The L3 form of AFP is separated from other AFP forms using a special chemical method.
- When a specific chemical is added, a fluorescent reaction is produced and is measured inside an instrument.
- The amount of fluorescence produced shows the level of AFP-L3 and total AFP in the blood.
- The more AFP-L3 in the sample, the greater the chance the patient will develop liver cancer.
When is it used? The Wako LBA AFP-L3 test is used in patients with chronic liver disease. The amount of L3 increases when liver cancer develops. This test can help a doctor determine the chances that a patient will advance to liver cancer in the next two years so the patient can be appropriately managed and treated.
What will it accomplish? The Wako LBA AFP-L3 test helps to determine the risk of developing liver cancer for a patient with chronic liver disease within the next 21 months. If the AFP-L3% is greater or equal to 10%, the risk is seven-fold.
When should it not be used? There are no contraindications for this device.
Additional information: Summary/Approval letter can be found at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k041847.pdf