This is a brief overview of information related to FDA's declared substantially equivalent to a legally marked device for this product. See the links below to the manufacturer's submitted 510(k) Summary that provides an understanding of the basis for a determination of substantial equivalence.
Product Name: Metrika A1cNow® for Home Use
Address: 510 Oakmead Parkway, Sunnyvale, CA 94085
Clearance Date:December 13, 2002
Clearance Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022661.pdf
What is it? The Metrika A1c is a test that measures the amount of glycated hemoglobin in diabetes patient's blood. Glycated hemoglobin is formed when the hemoglobin in a person's red blood cells interacts with glucose (sugar). Diabetics should be tested for glycated hemoglobin several times a year to help check on how well their disease is under control. Until now, the test was performed in a doctor's office. The FDA has now approved this test for purchase without a prescription. The patient can perform it at home and get the results right away.
How does it work? Diabetes patients place their fingerstick blood into the monitoring device provided. The monitoring device displays the test results in eight minutes.
When is it used? Diabetes patients should use this test two to four times a year to add information to what is gained from their daily fingerstick blood glucose measurements.
What will it accomplish? The results of the Metrika A1c Now test shows the average glucose levels over a 90 to 120 day period.
When should it not be used? The Metrika A1c should not be used to measure daily glucose levels.
Additional information: 510(k) Summary and labeling will be available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022661.pdf