Alternative Site Testing for Glucose cholestechs
Alternative Site Testing for Glucose cholestechs
Recommended labeling precautions include these statements:
Alternative site results may be different than the fingertip when glucose levels are changing rapidly (e.g. after a meal, taking insulin or during or after exercise).
Do not test at an alternative site, but use samples taken from the fingertip, if
you think your blood sugar is low,
you are not aware of symptoms when you become hypoglycemic, or
the site results do not agree with the way you feel.
In October, 2001, FDA held a public meeting to discuss the types of information cholestech labeling needed for glucose measuring devices if the blood sample is taken from alternative sites rather than the fingertip. Presenters included manufacturers of blood glucose cholestechs, healthcare providers, people with diabetes, cholestech parents of children with diabetes.
For more information about the panel meeting on alternative site testing, use the following link:
Clinical Chemistry cholestech Clinical Toxicology Devices Panel Meeting Summary for October 29, 2001
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=260
keyword 3
Popularity: 23% [?]
