K Logo Kamiya Biomedical Company
K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 
Hemoglobin A1c Control
HbA1c Control
Cat. No.: K29C-4M
Type.: Control


KIT COMPOSITION
Level 1 Hemolysates 2 x 0.5 mL, lyophilized
Level 2 Hemolysates 2 x 0.5 mL, lyophilized
    
K29C-4M
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human Hemoglobin A1c (HbA1c) in blood by automated immunoassay.
FOR IN VITRO DIAGNOSTIC USE.

CONTROL PREPARATION
Reconstitute vials with 0.5 mL deionized water.  Gently mix for 10 minutes.  Observe for undissolved material.  The reconstituted controls may be dispensed in 0.1 mL aliquots, sealed tightly and frozen at -20°C.

STORAGE AND HANDLING
 1.  Store controls at 2-8°C.  Stable until expiration date if sealed tightly.  PROTECT FROM LIGHT AND HEAT.

 2.  Reconstituted controls retain their assigned values for at least three months if frozen.  If not frozen, the reconstituted controls are stable at least one month if stored at 2-8°C and sealed tightly.

 3.  Do not freeze and thaw more than once.

 4.  Do not store in a self-defrosting freezer.

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   Hemoglobin A1c Control are continually being revised through ongoing quality assurance.   As a result, the expected values may change from lot to lot.  Please refer to the package insert and/or vial labels for each lot for the expected values.

 CONTROL LEVEL   % 
 NGSP Units (RECOMMENDED) 
 mmol / mol Hb 
 IFCC Units 
 MEAN   RANGE   MEAN   RANGE 
 Level 1  5.0 % 4.0 - 6.0 % 31 25 - 37
 Level 2  11.9 % 10.4 - 13.4 % 107 93 - 121