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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Quotient Diagnostics Limited
ClinicalTrials.gov Identifier:
NCT01829061
First received: April 1, 2013
Last updated: November 5, 2013
Last verified: November 2013

April 1, 2013
November 5, 2013
April 2013
December 2013   (final data collection date for primary outcome measure)
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01829061 on ClinicalTrials.gov Archive Site
Obtain CLIA Waiver Status for the Quo-Test [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Observational
Not Provided
Not Provided
Retention:   Samples Without DNA
Description:

Whole Blood Venous Draw and Capillary Blood - IVD Study

Non-Probability Sample

From site's patient database

Diabetes
Not Provided
No Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
360
January 2014
December 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01829061
QDL Clinical Studies
No
Quotient Diagnostics Limited
Quotient Diagnostics Limited
Not Provided
Principal Investigator: Tim Bailey, MD AMCR Institute
Principal Investigator: Stephanie Svoboda, PharmD Ridgeview Research
Principal Investigator: Michael Gardner, MD University of Missouri-Columbia
Quotient Diagnostics Limited
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP