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Hba1C Calibrator: Packing Insert

This document provides instructions for using HbA1c Calibrator, which is intended to determine the percentage of HbA1c in human blood samples using HPLC. It contains two levels of calibrator that are traceable to an ion exchange chromatography method. Instructions describe dissolving and using the lyophilized calibrators to establish a standard curve to measure HbA1c levels in samples, with performance standards for accuracy, precision, and safety. Precautions note the calibrators are for in vitro use only and should be handled with care.

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Michael Tanglao
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978 views2 pages

Hba1C Calibrator: Packing Insert

This document provides instructions for using HbA1c Calibrator, which is intended to determine the percentage of HbA1c in human blood samples using HPLC. It contains two levels of calibrator that are traceable to an ion exchange chromatography method. Instructions describe dissolving and using the lyophilized calibrators to establish a standard curve to measure HbA1c levels in samples, with performance standards for accuracy, precision, and safety. Precautions note the calibrators are for in vitro use only and should be handled with care.

Uploaded by

Michael Tanglao
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
  • Expiry Date: Specifies the criteria for determining the calibrator's expiration date.
  • Limitations of Procedure: Covers limitations related to the procedure of using the calibrator and possible errors.
  • Procedure: Outlines the procedure for using the calibrator in clinical settings.
  • Calibration Referring Value: Provides reference values necessary for scaling and interpreting calibration results.
  • Application: Discusses the specific usage settings and limitations for the HbA1c Calibrator.
  • Composition: Lists the components included in the HbA1c Calibrator mixture.
  • Storage and Stability: Describes storage conditions and stability parameters for maintaining the product's efficacy.
  • Introduction: Provides an introduction to the HbA1c Calibrator, highlighting its purpose and usage in blood testing.
  • Authorized Representation in European Community: Details about the authorized representative in Europe for the calibrator product.
  • Version and Modification Date: Indicates the version and the last modification date of the document.
  • Manufacturer Information: Contains the manufacturer's contact information and location details.

HbA1c Calibrator

Packing Insert
【Intend Use】
HbA1c Calibrator is intended for the percent determination of HbA1c in human blood using High
Performance Liquid Chromatography (HPLC).
【Principle】
Form correspondence between the concentration of HbA1c and the variation of peak area ratio by testing
calibrator level 1 and level 2. Establish standard curve to measure the concentration of HbA1c in sample.
【Application】
It’s only for use with Lifotronic GH and H series HbA1c system.
【Composition】
1. Calibrator includes hemoglobin from lyophilized whole blood, preservatives and stabilizers.
2. It’s traceable to NGSP Ion Exchange Chromatography method.
【Packing Specification】
The kit includes calibrator level 1, level 2
2×0.1mL
【Expiry Date】
1. Store at 2~8°C, keep in dark place. The calibrator is provided in lyophilized form for increased stability
2. Expiry Date, shelf life is 12 months. After resolved, it will be stable for 7 days at -20°C
【Operation Step】
1. Open vial, and place at room temperature for 10~15 minutes.
2. Add 100μL deionized water with pipette to dissolve level 1 and level 2, then stand for 30 minutes.
3. Tighten the vial covers and shake them gently and thoroughly.
4. Then choose suitable centrifuge tubes to dispatch, label and use.
【Limitation of the Procedure】
Refer to the operation guide to use the calibrator. If not, the measured results are not reliable.
【Performance Standard】
1. Appearance:Visual inspection:be red loose dried frozen aquatic products, be red liquid after redissolving .
2. Packing volume of level 1,level 2:≥2.7g.
3. Accuracy of level 1,level 2:Bias% should be in the range of ± 10%.
4. Intra-assay precision of level 1,level 2:CV≤5%.
5. Inter-assay precision of level 1,level 2:CV≤10%.
6. Bio-safety of level 1,level 2:HBsAg,HIV antibody,HCV antibody,TP antibody are negative.
【Precautions/Warnings】
1. For In Vitro Diagnostic Use.
2. Each unit of whole blood used in the manufacturer of the calibrators was tested by CFDA approved
methods and found non-reactive for HbsAg, HCV, HIV-1, HIV-2 and TP. No test method can offer complete
assurance from infection. In accordance with good laboratory practice, all human source material should be
considered potentially infectious; therefore, handle the calibrators with the same precautions used with patient
specimens.
【Calibration Referring Value】
See the reference Value on the vial.
【Manufacturer】
Shenzhen Lifotronic Technology Co., Ltd
Add ： Unit A, 4th Floor, Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan District, Shenzhen City,
Guangdong Province, 518055, [Link]
Mail：service@[Link]

【Authorized representative in the European Community】

Shanghai International Holding Corp. GmbH (Europe)

Add：Eiffestrasse 80, 20537 Hamburg，Germany


【Version and Modification Date】
Version: A5
Modification Date: 2018-03-16

HbA1c Calibrator Packing Insert 【Intend Use】 HbA1c Calibrator is intended for the percent determination of HbA1c in human blo
See the reference Value on the vial. 【Manufacturer】 Shenzhen Lifotronic Technology Co., Ltd Add：Unit A, 4th Floor, Building 1

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