OneDraw A1C Test System
$109.00
The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional. Samples are delivered to the laboratory for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes. The OneDraw A1C Test System should not be used with neonates.
Kit Includes:
- OneDraw Collection Device
- Alcohol pad
- Gauze pad
- Adhesive bandage
- Chipboard mailer
- Sample transport sleeve
Indication for Use: The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional.
Sample Type: Whole dried blood
Blood Collection Volume: 2 samples of 75μL, CV of <5%
Blood Collection Substrate: 8mm x 22mm Drawbridge Volumetric Matrix
Collection Time: 5 minutes
Drying Requirement: Sample placed directly in Transport Sleeve, no need to wait for drying.
Kit Size and Weight: (6 x 5 x 2.4) in - 4.0oz/120g
Shipping: Sample ships as an exempt human specimen via standard post such as FedEx or USPS.
Barcoding: All devices are ISO13485 UDI compliant.
Device Storage: 15-25° C
Device Transport: Transport at 25-85% RH
Shelf Life: 12 months
Design: Engineered by Drawbridge Health USA
Availability: OneDraw devices are available in the US for Research or Investigation Use Only. The performance characteristics of this product have not been established. These devices are also currently CE-IVD self-certified in the UK and EU. In some countries, the OneDraw device may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations. In the US, the OneDraw A1C Test System is FDA cleared for Diabetes Monitoring.
Additional information
| Weight | 0.120 kg |
|---|---|
| Dimensions | 15 × 12.7 × 6.35 cm |
