DRUG CAL II (DRUG CAL II)
Current Revision and Datea Rev. 04, 2019-07
Product Name Atellica CH DRUG CAL II (DRUG CAL II)
Abbreviated Product Name Atellica CH DRUG CAL II
2 x 5.0 mL calibrator level 1 11099405
2 x 5.0 mL calibrator level 2
2 x 5.0 mL calibrator level 3
2 x 5.0 mL calibrator level 4
2 x 5.0 mL calibrator level 5
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 DRUG CAL II (DRUG CAL II) is for in vitro diagnostic use in calibrating the Carb,
Gent, LIDO, NAPA, PROC, Tob, Vanc and VPA assays using 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 DRUG CAL II Unopened at 2–8°C Until expiration date on product
5.0 mL/vial
Analytes for assays listed in Intended Use; bovine serum Opened at 2–8°C 30 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.
Safety data sheets (SDS) available on siemens.com/healthineers.
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DRUG CAL II Atellica CH Analyzer
CAUTION
This device contains material of animal origin and should be handled as a potential carrier and
transmitter of disease.
The Packaging of This Product Contains Dry Natural Rubber.
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 30 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
Allow to equilibrate to room temperature and mix thoroughly before 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/healthineers
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
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Atellica CH Analyzer DRUG CAL II
Symbol Symbol Title and Description
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
Oxidizing
Explosive
Toxic
Compressed gas
Keep away from sunlight
Prevent exposure to sunlight and heat.
Up
Store in an upright position.
Do not freeze
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DRUG CAL II Atellica CH Analyzer
Symbol Symbol Title and Description
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
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)
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Atellica CH Analyzer DRUG CAL II
Symbol Symbol Title and Description
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.
© 2016–2019 Siemens Healthcare Diagnostics. All rights reserved.
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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