FDA News

FDA clears new point-of-care HbA1c assay

Abbott announced that the FDA has cleared a rapid point-of-care test to diagnose diabetes and assess patient risk for developing diabetes.

The Afinion HbA1c Dx assay is now cleared for use with the Afinion AS100 Analyzer, a multi-assay analyzer that provides near-patient testing of HbA1c and albumin to creatinine ratio at the point of care, according to a company press release.

Clearance was based on analytical and clinical studies, in which the Afinion HbA1c Dx assay demonstrated accurate and precise results that are comparable to results with central laboratory systems, according to the release.

“Access to rapid results at the point of care expedites diagnosis and allows providers to initiate immediate follow up and, ultimately, help their patients take control of their health,” Richard Kahn, PhD, former chief scientific and medical officer of the American Diabetes Association, stated in the release.

The Afinion HbA1c Dx assay will be available in the United States in late 2018. The Afinion HbA1c assay on the Afinion AS100 Analyzer was previously cleared in 2005 for rapid delivery of HbA1c results for management of diabetes at the point of care. In 2006, the FDA granted a Clinical Laboratory Improvements Amendments (CLIA) waiver for this system, which enabled broader use in qualified health care settings. The new clearance for the expanded diagnostic indication is specific to CLIA-certified laboratories to perform tests that are of moderate complexity or higher; clearance does not extend to laboratories that can only perform CLIA-waived tests, according to the company.

 

 

Abbott announced that the FDA has cleared a rapid point-of-care test to diagnose diabetes and assess patient risk for developing diabetes.

The Afinion HbA1c Dx assay is now cleared for use with the Afinion AS100 Analyzer, a multi-assay analyzer that provides near-patient testing of HbA1c and albumin to creatinine ratio at the point of care, according to a company press release.

Clearance was based on analytical and clinical studies, in which the Afinion HbA1c Dx assay demonstrated accurate and precise results that are comparable to results with central laboratory systems, according to the release.

“Access to rapid results at the point of care expedites diagnosis and allows providers to initiate immediate follow up and, ultimately, help their patients take control of their health,” Richard Kahn, PhD, former chief scientific and medical officer of the American Diabetes Association, stated in the release.

The Afinion HbA1c Dx assay will be available in the United States in late 2018. The Afinion HbA1c assay on the Afinion AS100 Analyzer was previously cleared in 2005 for rapid delivery of HbA1c results for management of diabetes at the point of care. In 2006, the FDA granted a Clinical Laboratory Improvements Amendments (CLIA) waiver for this system, which enabled broader use in qualified health care settings. The new clearance for the expanded diagnostic indication is specific to CLIA-certified laboratories to perform tests that are of moderate complexity or higher; clearance does not extend to laboratories that can only perform CLIA-waived tests, according to the company.