Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
The Tosoh G8 (Tosoh Automated Glycohemoglobin Analyzer HLC-723G8) has been cleared by the FDA as the first HPLC instrument to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes.
The Tosoh G8 was initially cleared by the agency in 2008 as a diabetes monitoring device. The intended use has now been expanded so the Tosoh G8 can be used for screening as well. The ADA Clinical Practice Recommendations state that HbA1c can be used to diagnose diabetes using a NGSP-certified method and a cutoff of HbA1c ≥6.5%.
http://www.selectscience.net/produc...y-FDA-for-Diagnosis-of-Diabetes/?&artID=31480
The Tosoh G8 was initially cleared by the agency in 2008 as a diabetes monitoring device. The intended use has now been expanded so the Tosoh G8 can be used for screening as well. The ADA Clinical Practice Recommendations state that HbA1c can be used to diagnose diabetes using a NGSP-certified method and a cutoff of HbA1c ≥6.5%.
http://www.selectscience.net/produc...y-FDA-for-Diagnosis-of-Diabetes/?&artID=31480