ms_03045846122V14.

CA 15-3 II CalSet
03045846122 4 x 1.0 mL
For USA: Elecsys CA 15-3 II CalSet

English All human material should be considered potentially infectious. All products
derived from human blood are prepared exclusively from the blood of
Intended use donors tested individually and shown to be free from HBsAg and antibodies
CA 15‑3 II CalSet is used for calibrating the quantitative Elecsys CA 15‑3 II to HCV and HIV. The testing methods use assays that have been approved
assay on the Elecsys and cobas e immunoassay analyzers. by the FDA or that are in compliance with the legal rules applicable to
Summary placing in vitro diagnostic medical devices for human use on the market in
the European Union.
CA 15‑3 II CalSet is a ready-for-use human serum matrix with added However, as no testing method can rule out the potential risk of infection
human CA 15‑3 in two concentration ranges. with absolute certainty, the material should be handled with the same level
The CalSet can be used with all reagent lots. of care as a patient specimen. In the event of exposure, the directives of the
Reagents - working solutions responsible health authorities should be followed.1,2
Avoid foam formation in all reagents and sample types (specimens,
▪ CA 15‑3 II Cal1: 2 bottles, each containing 1.0 mL of calibrator 1 calibrators and controls).
▪ CA 15‑3 II Cal2: 2 bottles, each containing 1.0 mL of calibrator 2
Handling
CA 15‑3 (human) in two concentration ranges (approximately 15 U/mL and
approximately 100 U/mL) in a human serum matrix. The calibrators are supplied ready‑for‑use in bottles compatible with the
system.
cobas e 801 analyzer: The exact lot‑specific calibrator values are encoded
in the electronic barcode and available via the cobas link. cobas e 411 analyzer: The calibrators should only be left on the analyzer
All other analyzers: The exact lot‑specific calibrator values are encoded in during calibration at 20‑25 °C. After use, close the bottles as soon as
the barcode as well as printed on the enclosed (or electronically available) possible and store upright at 2‑8 °C.
calibrator barcode sheet. Due to possible evaporation effects, not more than 5 calibration procedures
per bottle set should be performed.
Calibrator values
MODULAR ANALYTICS E170, cobas e 601, cobas e 602 and
Traceability: The Elecsys CA 15‑3 II assay has been standardized against cobas e 801 analyzers: Unless the entire volume is necessary for
the Elecsys CA 15‑3 assay ( 01776169). calibration on the analyzers, transfer aliquots of the ready‑for‑use
Precautions and warnings calibrators into empty snap-cap bottles (CalSet Vials). Attach the supplied
For in vitro diagnostic use for health care professionals. Exercise the labels to these additional bottles. Store the aliquots at 2‑8 °C for later use.
normal precautions required for handling all laboratory reagents. Perform only one calibration procedure per aliquot.
Infectious or microbial waste: Please note for cobas e 602 and cobas e 801 analyzers: Both the vial
Warning: handle waste as potentially biohazardous material. Dispose of labels, and the additional labels (if available) contain 2 different barcodes.
waste according to accepted laboratory instructions and procedures. Please turn the vial cap 180° into the correct position so that the barcode
between the yellow markers can be read by the system. Place the vial on
Environmental hazards: the analyzer as usual.
Apply all relevant local disposal regulations to determine the safe disposal.
Safety data sheet available for professional user on request. Storage and stability
Store at 2‑8 °C.
For USA: Caution: Federal law restricts this device to sale by or on the
order of a physician. Stability:
This kit contains components classified as follows in accordance with the
Regulation (EC) No. 1272/2008: unopened at 2‑8 °C up to the stated expiration date
after opening/in aliquots at 2‑8 °C 12 weeks
on cobas e 411 analyzers at up to 5 hours
20‑25 °C
on MODULAR ANALYTICS E170, use only once
Warning cobas e 601, cobas e 602 and
cobas e 801 analyzers at 20‑25 °C
H317 May cause an allergic skin reaction.
Store calibrators upright in order to prevent the calibrator solution from
Prevention: adhering to the snap‑cap.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray. Materials provided
▪ CA 15‑3 II CalSet, barcode card, calibrator barcode sheet, 2 x 6 bottle
P272 Contaminated work clothing should not be allowed out of labels
the workplace. Materials required (but not provided)
P280 Wear protective gloves. ▪ 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles
Response: ▪ MODULAR ANALYTICS E170 or cobas e immunoassay analyzers and
Elecsys CA 15‑3 II assay reagents.
P333 + P313 If skin irritation or rash occurs: Get medical See the assay Method Sheet and the operator’s manual for additionally
advice/attention. required materials.
Assay
P362 + P364 Take off contaminated clothing and wash it before reuse. Place the bottles in the sample zone.
Disposal: Read in all the information necessary for calibrating the assay.
P501 Dispose of contents/container to an approved waste Ensure the calibrators are at 20‑25 °C prior to measurement.
disposal plant. References
Product safety labeling follows EU GHS guidance. 1 Occupational Safety and Health Standards: Bloodborne pathogens.
(29 CFR Part 1910.1030). Fed. Register.
Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

2021-08, V 14.0 English 1/2

ms_03045846122V14.0

CA 15-3 II CalSet
2 Directive 2000/54/EC of the European Parliament and Council of
18 September 2000 on the protection of workers from risks related to
exposure to biological agents at work.
For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets, the product
information and the Method Sheets of all necessary components (if
available in your country).
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
CA 15‑3 is a registered trademark of
Fujirebio Diagnostics, Inc.
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
The Summary of Safety & Performance Report can be found here:
https://ec.europa.eu/tools/eudamed
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number

FOR US CUSTOMERS ONLY: LIMITED WARRANTY

Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and will
be free from defects in material and workmanship until the expiration date
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES.
COBAS, COBAS E and ELECSYS are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2020, Roche Diagnostics

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim

www.roche.com
+800 5505 6606

Distribution in USA by:

Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

2/2 2021-08, V 14.0 English