Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System

Diabetes Clinical Trial

Official title:

Reproducibility and Method Comparison of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver of the Quo-Test™ A1C System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01829061
• Other study ID #: QDL Clinical Studies
• Status: Terminated
• Phase: N/A
• First received: April 1, 2013
• Last updated: March 28, 2016
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: November 2013
• Source: Quotient Diagnostics Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing devices should be used with this system.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or over

• Able to read English

• Read, understood and signed the Informed Consent Form

• Agrees to participate and does not withdraw\

• Either healthy (without diabetes) or has Type 1 or Type 2 diabetes

Exlcusion Criteria:

• Declines participation or withdraws before study completion

Study Design

N/A

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	Ridgeview Research	Chaska	Minnesota
United States	University of Missouri	Columbia	Missouri
United States	AMCR Institute	Escondido	California

Sponsors (1)

Lead Sponsor	Collaborator
Quotient Diagnostics Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C	The objective is to conduct a method comparison between both the Quo-Test and Quo-Lab investigational devices and the reference method [Tosoh G8 (K071132)]. The reference method also serves as the predicate for the premarket notifications for both investigational devices. Both capillary and venous samples will be tested on the Quo-Test A1C System and Quo-Lab A1C Test, while only venous samples will be tested on the reference method.	10 Days	No
Secondary	Obtain CLIA Waiver Status for the Quo-Test		10 Days	No