ms_07030207190V6.

CA 125 II CalSet II
07030207190 4 x 1.0 mL
For USA: Elecsys CA 125 II CalSet II

English Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

Intended use All human material should be considered potentially infectious. All products
CA 125 II CalSet II is used for calibrating the quantitative Elecsys CA 125 II derived from human blood are prepared exclusively from the blood of
assay on cobas e immunoassay analyzers. donors tested individually and shown to be free from HBsAg and antibodies
to HCV and HIV. The testing methods use assays that have been approved
Summary by the FDA or that are in compliance with the legal rules applicable to
CA 125 II CalSet II is a lyophilized equine serum matrix (CA125 II Cal1) and placing in vitro diagnostic medical devices for human use on the market in
human serum matrix with added human CA 125 (CA125 II Cal2). the European Union.
However, as no testing method can rule out the potential risk of infection
The CalSet can be used with all reagent lots. with absolute certainty, the material should be handled with the same level
Reagents - working solutions of care as a patient specimen. In the event of exposure, the directives of the
responsible health authorities should be followed.1,2
▪ CA125 II Cal1: 2 bottles, each for 1.0 mL of calibrator 1
Avoid foam formation in all reagents and sample types (specimens,
▪ CA125 II Cal2: 2 bottles, each for 1.0 mL of calibrator 2 calibrators and controls).
The concentration of human CA 125 in the equine serum matrix
(CA125 II Cal1) is 0 U/mL; CA125 II Cal2 contains approximately 500 U/mL Handling
human CA 125 in the human serum matrix; preservative. Carefully dissolve the contents of one bottle by adding exactly 1.0 mL of
distilled or deionized water and allow to stand closed for 15 minutes to
reconstitute. Mix carefully, avoiding foam formation.
Calibrator values Transfer the reconstituted calibrators into the supplied empty labeled
The calibrator values are encoded either in the barcode or in the electronic snap‑cap bottles.
barcode (which is available via the cobas link). cobas e 411 analyzer: The reconstituted calibrators should only be left on
Traceability: The Elecsys CA 125 II assay has been standardized against the analyzer during calibration at 20‑25 °C. After use, close the bottles as
the Enzymun‑Test CA 125 II method. This in turn was standardized against soon as possible and store upright at 2‑8 °C.
the CA 125 II RIA from Fujirebio Diagnostics. Due to possible evaporation effects, not more than 5 calibration procedures
Precautions and warnings per bottle set should be performed.
For in vitro diagnostic use for health care professionals. Exercise the All other analyzers: Unless the entire volume is necessary for calibration on
normal precautions required for handling all laboratory reagents. the analyzers, transfer aliquots of the reconstituted calibrators into empty
snap‑cap bottles (CalSet Vials). Attach the supplied labels to these
Infectious or microbial waste: additional bottles. Aliquots intended for storage at ‑20 °C (± 5 °C) should be
Warning: handle waste as potentially biohazardous material. Dispose of frozen immediately.
waste according to accepted laboratory instructions and procedures. Perform only one calibration procedure per aliquot.
Environmental hazards: Please note for cobas e 402, cobas e 602 and cobas e 801 analyzers:
Apply all relevant local disposal regulations to determine the safe disposal. Both the vial labels, and the additional labels (if available) contain 2
Safety data sheet available for professional user on request. different barcodes. Please turn the vial cap 180° into the correct position so
For USA: Caution: Federal law restricts this device to sale by or on the that the barcode between the yellow markers can be read by the system.
order of a physician. Place the vial on the analyzer as usual.
This kit contains components classified as follows in accordance with the Storage and stability
Regulation (EC) No. 1272/2008: Store at 2‑8 °C.
The lyophilized calibrators are stable up to the stated expiration date.
Stability of the reconstituted calibrators:
either at -20 °C (± 5 °C) 20 weeks (freeze only once)
or at 2‑8 °C 12 weeks
Warning
on cobas e 411 analyzer at up to 5 hours
H317 May cause an allergic skin reaction. 20‑25 °C
H412 Harmful to aquatic life with long lasting effects. on all other analyzers at 20‑25 °C use only once
Prevention: Store calibrators upright in order to prevent the calibrator solution from
adhering to the snap‑cap.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray. Materials provided
P273 Avoid release to the environment. ▪ CA 125 II CalSet II, barcode card, 4 empty labeled snap-cap bottles,
2 x 4 bottle labels
P280 Wear protective gloves. Materials required (but not provided)
Response: ▪ 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles
P333 + P313 If skin irritation or rash occurs: Get medical ▪ cobas e immunoassay analyzers and Elecsys CA 125 II assay reagents
advice/attention. See the assay Method Sheet and the operator’s manual for additionally
required materials.
P362 + P364 Take off contaminated clothing and wash it before reuse. Assay
Disposal: Place the reconstituted calibrators (in the system-compatible bottles with
barcoded labels) in the sample zone.
P501 Dispose of contents/container to an approved waste Read in all the information necessary for calibrating the assay.
disposal plant. Ensure the calibrators are at 20‑25 °C prior to measurement.
Product safety labeling follows EU GHS guidance.

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CA 125 II CalSet II
References
1 Occupational Safety and Health Standards: Bloodborne pathogens.
(29 CFR Part 1910.1030). Fed. Register.
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 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 125 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 for reconstitution
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.
© 2022, 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

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