Albumin BCP Calibrator (AlbP CAL)

Current Revision and Datea Rev. 04, 2024-05

Product Name Atellica CH Albumin BCP Calibrator (AlbP CAL)

Abbreviated Product Name Atellica CH AlbP CAL

3 x 2.0 mL calibrator 11099310

Calibrator lot-specific value sheet

Systems Atellica CH Analyzer

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

Intended Use
The Atellica® CH Albumin BCP Calibrator (AlbP CAL) is for in vitro diagnostic use in calibrating
the Atellica CH AlbP assay using an Atellica® chemistry 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 AlbP CAL Unopened at 2–8°C Until expiration date on

Lyophilized; reconstituted to 2.0 mL/vial product
Lyophilized human serum-based product containing albumin
Reconstituted at 2–8°C 8 hours
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-healthineers.com.

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Warning! Potential Biohazard

Contains human source material.
No known test method can ensure that products derived from human source materials will not
transmit infection. These materials should be handled using good laboratory practices and
universal precautions.1‑3

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.
Reconstituted calibrators are stable at 2–8°C for 8 hours.
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

Prepare calibrators using the following steps:
1. Remove vial from refrigerator and allow to stand at room temperature for 10 to
15 minutes.
2. Remove the rubber stopper and pipette 2.00 mL (+/- 0.01 mL) of special reagent water.
The water should be equilibrated to room temperature.
Note For information about special reagent water requirements, refer to the online help.
3. Replace the rubber stopper and let stand for 5 minutes. Do not invert vial.
4. Swirl vial gently for 60 seconds, then gently invert 20 times.
5. Let vial stand for 10 minutes, then gently invert 20 times.
6. Let vial stand for 30 minutes. Then invert gently 20 times and swirl gently.
7. Use immediately or refrigerate at 2–8°C for future use. Prior to use, visually inspect vial for
undissolved material. If present, position vial to fully immerse undissolved material in
liquid. Let stand for 10 minutes. Then invert 20 times and swirl gently.

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Calibration Procedure
Dilution is performed automatically by the analyzer using an Atellica CH Diluent as Level 1 and
the Atellica CH AlbP CAL for Level 2.
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
According to EU regulation 2017/746, any serious incident that has occurred in relation to the
device shall be reported to the manufacturer and the competent authority of the EU Member
State in which the user and/or patient is established.
For customer support, contact your local technical support provider or distributor.
siemens-healthineers.com

References
1. US Department of Health and Human Services. Biosafety in Microbiological and
Biomedical Laboratories. 5th ed. Washington, DC: US Government Printing Office;
December 2009.
2. World Health Organization. Laboratory Biosafety Manual. 3rd ed. Geneva: World Health
Organization; 2004.
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 Source Symbol Symbol Title Source

Manufacturer 5.1.1a Authorized representative 5.1.2a

in the European
Community

Use-by date 5.1.4a Authorized representative Proprietary

in Switzerland

Catalog number 5.1.6a Batch code 5.1.5a

Consult Instructions for 5.4.3a Contains sufficient for <n> 5.5.5a

Use tests

Internet URL address to Proprietary Version of Instructions for Proprietary

access the electronic Use
instructions for use

In vitro diagnostic medical 5.5.1a Revision Proprietary

device

Prescription device (US FDAb Unique Device Identifier 5.7.10c

only)

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Symbol Symbol Title Source Symbol Symbol Title Source

CE Marking with Notified EU IVDRd CE Marking EU IVDRd

Body

Temperature limit 5.3.7a Keep away from sunlight 5.3.2a

Upper limit of tempera- 5.3.6a Lower limit of temperature 5.3.5a

ture

Do not re-use 5.4.2a Do not freeze Proprietary

Recycle 1135e This way up 0623e

Biological risks 5.4.1a Caution 5.4.4a

Common Units Proprietary International System of Proprietary

Units

YYYY-MM-DD Date format (year-month- N/A YYYY-MM Date format (year-month) N/A
day)

Document face upf 1952e Handheld barcode scanner Proprietary

Target Proprietary Mixing of substances 5657g

Variable hexadecimal Proprietary Interval Proprietary

number that ensures the
Master Curve and Cali-
brator definition values
entered are valid.

Unique material identifica- Proprietary Material Proprietary

tion number

Type of control Proprietary Name of control Proprietary

Quality control lot value Proprietary Calibrator lot value Proprietary

a International Standard Organization (ISO). ISO 15223-1 Medical Devices- Symbols to be used with medical
device labels, labelling and information to be supplied.
b Federal Register. Vol. 81, No 115. Wednesday, June 15, 2016. Rules and Regulations: 38911.
c ISO 15223-1:2020-04
d IVDR REGULATION (EU) 2017/746
e International Standard Organization (ISO). ISO 7000 Graphical symbols for use on equipment.
f Indicates Assay-eNote
g International Electrotechnical Commission (IEC). IEC 60417-1 Graphical symbols for use on equipment – Part 1:
Overview and Application

Legal Information
Atellica is a trademark of Siemens Healthineers.
© 2022–2024 Siemens Healthineers. All rights reserved.

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Siemens Healthcare Diagnostics Inc.

511 Benedict Avenue
Tarrytown, NY 10591 USA

siemens-healthineers.com

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