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Anticipated FDA Regulatory Approval under 510(k) – 90 day turnaround after submission

Substantially Equivalent Devices with FDA approval:

1. Affinity Chromatography test for Glycated Albumin (currently performed in the clinical laboratory)
2. ELISA antibody-based test for Glycated Albumin
3. Metrika OTC HbA1c test
4. Fructosamine test approved for OTC and professional use in the mid-1990s

G1A™ Clinical Trial Protocol

• 6 months
• 1000 patients

Two simultaneous trials

• Type 2 diabetics
• Gestational diabetics

Objective: To demonstrate the impact of early intervention using the G1A™ test

This product is under development and is intended for informational and evaluation purposes only. It is NOT APPROVED by the FDA