Cystatin C_2 Calibrators (CYSC_2 CAL)

Current Revision and Datea Rev. 02, 2019-07

Product Name Atellica® CH Cystatin C_2 Calibrators (CYSC_2 CAL)

Abbreviated Product Name Atellica® CH CYSC_2 CAL

1 x 2.0 mL calibrator level 2 11097648

1 x 2.0 mL calibrator level 3
1 x 2.0 mL calibrator level 4
1 x 2.0 mL calibrator level 5
1 x 2.0 mL calibrator level 6
Calibrator lot-specific value sheet

Systems Atellica CH Analyzer

a A vertical bar in the page margin indicates technical content that differs from the previous version.

Intended Use
The Atellica® CH Cystatin C_2 Calibrators (CYSC_2 CAL) are for in vitro diagnostic use in the
calibration of the Atellica® CH Cystatin C_2 (CYSC_2) assay on the Atellica® CH Analyzer.

Material Description
For the assigned values, refer to the calibrator lot‑specific value sheet provided.
The assigned values are traceable to the standardization of the assay.

Material Description Storage Stabilitya

Atellica CH CYSC_2 CAL Unopened at 2–8°C Until expiration date

2.0 mL/vial on product
Human serum; recombinant human cystatin C; sodium
azide (< 0.1%) Opened at 2–8°C 60 days

a Refer to Storage and Stability

Warnings and Precautions

For in vitro diagnostic use.
For Professional Use.

CAUTION
Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare
professional.

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Safety data sheets (SDS) available on siemens.com/healthcare.

CAUTION POTENTIAL BIOHAZARD

Contains human source material. Each donation of human blood or blood component was
tested by FDA-approved methods for the presence of antibodies to human immunodeficiency
virus type 1 (HIV‑1) and type 2 (HIV‑2), as well as for hepatitis B surface antigen (HBsAg) and
antibody to hepatitis C virus (HCV). The test results were negative (not repeatedly reactive).
No test offers complete assurance that these or other infectious agents are absent; this
material should be handled using good laboratory practices and universal precautions.1‑3

Contains sodium azide as a preservative. Sodium azide can react with copper or lead plumbing
to form explosive metal azides. On disposal, flush reagents with a large volume of water to
prevent buildup of azides. Disposal into drain systems must be in compliance with prevailing
regulatory requirements.
Dispose of hazardous or biologically contaminated materials according to the practices of your
institution. Discard all materials in a safe and acceptable manner and in compliance with
prevailing regulatory requirements.
Note For information about calibrator preparation, refer to Preparing the Calibrators.

Storage and Stability

Unopened calibrators are stable until the expiration date on the product when stored at
2–8°C. Opened stability is 60 days when recapped immediately after use and stored at 2–8°C.
For information about storage and stability of materials in the Cal‑QC tube storage area, refer
to the supplementary document “Atellica Sample Handler Calibrator and QC Storage and
Stability.”
Do not use products beyond the expiration date printed on the product labeling.

Performing Calibration
Calibration Frequency
Follow government regulations or accreditation requirements for calibration frequency.
Individual laboratory quality control programs and procedures may require more frequent
calibration.
For information about calibration frequency, refer to the assay instructions for use.

Preparing the Calibrators

Calibrators are liquid and ready to use.

Calibration Procedure
Use the following lot‑specific materials to perform calibration:
• For the calibrator definitions, refer to the lot‑specific value sheet provided with
the calibrator materials.
• Generate lot‑specific barcode labels to use with the calibrator samples, if necessary.
For instructions about how to perform the calibration procedure, refer to the online help.

Technical Assistance
For customer support, contact your local technical support provider or distributor.
siemens.com/healthcare

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References
1. Centers for Disease Control. Perspectives in disease prevention and health promotion
update: Universal precautions for prevention of transmission of human immunodeficiency
virus, hepatitis B virus and other bloodborne pathogens in healthcare settings. MMWR.
1988;37(24):377–382, 387–388.
2. Clinical and Laboratory Standards Institute. Procedures for the Handling and Processing of
Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition.
Wayne, PA: Clinical and Laboratory Standards Institute; 2010. CLSI Document GP44‑A4.
3. Clinical and Laboratory Standards Institute. Protection of Laboratory Workers from
Occupationally Acquired Infections; Approved Guideline—Fourth Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2014. CLSI Document M29‑A4.

Definition of Symbols
The following symbols may appear on the product labeling:

Symbol Symbol Title and Description

Consult instructions for use

Version of instructions for use

Internet URL address to access the electronic instructions for use

Revision

Caution
Consult instructions for use or accompanying documents for cautionary information
such as warnings and precautions that cannot, for a variety of reasons, be presented
on the medical device.

Biological risks
Potential biological risks are associated with the medical device.

Corrosive

Dangerous to environment

Irritant
Oral, dermal, or inhalation hazard

Inhalation hazard
Respiratory or internal health

Flammable
Flammable to extremely flammable

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Symbol Symbol Title and Description

Oxidizing

Explosive

Toxic

Compressed gas

Keep away from sunlight

Prevent exposure to sunlight and heat.

Up
Store in an upright position.

Do not freeze

Temperature limit
Upper and lower limits of temperature indicators are adjacent to the upper and
lower horizontal lines.

Handheld barcode scanner

In vitro diagnostic medical device

Contains sufficient for <n> tests

Total number of IVD tests the system can perform with the IVD kit reagents appears
adjacent to the symbol.

Prescription device (US only)

Applies only to United States-registered IVD assays.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a
licensed healthcare professional.

Mixing of substances
Mix product before use.

Reconstitute and mix lyophilized product before use.

Target

Interval

Legal Manufacturer

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Symbol Symbol Title and Description

Authorized Representative in the European Community

Use-by date
Use by the designated date.

Batch code

Catalog number

Recycle

Printed with soy ink

CE Mark

CE Mark with notified body ID number

Notified body ID number can vary.

Date format (year‑month‑day)

Variable hexadecimal number that ensures the Master Curve and Calibrator
definition values entered are valid.

Common Units

International System of Units

Material

Unique material identification number

Name of control

Type of control

Legal Information
Atellica is a trademark of Siemens Healthcare Diagnostics.
© 2018–2019 Siemens Healthcare Diagnostics. All rights reserved.

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Siemens Healthcare Diagnostics Inc.

511 Benedict Avenue
Tarrytown, NY 10591
USA
siemens.com/healthineers

Siemens Healthineers Headquarters

Siemens Healthcare GmbH
Henkestr. 127
91052 Erlangen
Germany
Phone: +49 9131 84-0
siemens.com/healthineers

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