ms_11776215122V20.

CA 19-9 CalSet
11776215 122 4 x 1.0 mL
For USA: Elecsys CA 19-9 CalSet

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 19‑9 CalSet is used for calibrating the quantitative Elecsys CA 19‑9 derived from human blood are prepared exclusively from the blood of
assay on the Elecsys and 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 19‑9 CalSet is a lyophilized human serum with added human CA 19‑9 in placing in vitro diagnostic medical devices for human use on the market in
two concentration ranges. 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
▪ CA19‑9 Cal1: 2 bottles, each for 1.0 mL of calibrator 1
Avoid foam formation in all reagents and sample types (specimens,
▪ CA19‑9 Cal2: 2 bottles, each for 1.0 mL of calibrator 2 calibrators and controls).
CA 19‑9 (human) in two concentration ranges (approximately 20 U/mL and
approximately 250 U/mL) in a human serum matrix; preservative. Handling
cobas e 801 analyzer: The exact lot‑specific calibrator values are encoded Carefully dissolve the contents of one bottle by adding exactly 1.0 mL of
in the electronic barcode and available via the cobas link. distilled or deionized water and allow to stand closed for 15 minutes to
All other analyzers: The exact lot‑specific calibrator values are encoded in reconstitute. Mix carefully, avoiding foam formation.
the barcode as well as printed on the enclosed (or electronically available) Transfer the reconstituted calibrators into the supplied empty labeled
calibrator barcode sheet. snap‑cap bottles.
Calibrator values cobas e 411 analyzer: The reconstituted calibrators should only be left on
the analyzer during calibration at 20‑25 °C. After use, close the bottles as
Traceability: The Elecsys CA 19‑9 assay has been standardized against the soon as possible and store upright at 2‑8 °C.
Enzymun‑Test CA 19‑9 method.
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 If necessary, freeze in aliquots; see section on
normal precautions required for handling all laboratory reagents. MODULAR ANALYTICS E170, cobas e 601, cobas e 602 and
Infectious or microbial waste: cobas e 801 analyzers.
Warning: handle waste as potentially biohazardous material. Dispose of MODULAR ANALYTICS E170, cobas e 601, cobas e 602 and
waste according to accepted laboratory instructions and procedures. cobas e 801 analyzers: Unless the entire volume is necessary for
Environmental hazards: calibration on the analyzers, transfer aliquots of the reconstituted calibrators
Apply all relevant local disposal regulations to determine the safe disposal. into empty snap‑cap bottles (CalSet Vials). Attach the supplied labels to
Safety data sheet available for professional user on request. these additional bottles. Store the aliquots at ‑20 °C (± 5 °C) for later use.
For USA: Caution: Federal law restricts this device to sale by or on the Perform only one calibration procedure per aliquot.
order of a physician. Please note for cobas e 602 and cobas e 801 analyzers: Both the vial
This kit contains components classified as follows in accordance with the labels, and the additional labels (if available) contain 2 different barcodes.
Regulation (EC) No. 1272/2008: 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
the analyzer as usual.
Storage and stability
Store at 2‑8 °C.
The lyophilized calibrators are stable up to the stated expiration date.
Warning
Stability of the reconstituted calibrators:
H317 May cause an allergic skin reaction. either at -20 °C (± 5 °C) 2 months (freeze only once)
H412 Harmful to aquatic life with long lasting effects. or at 2‑8 °C 4 weeks
Prevention: on cobas e 411 analyzer at up to 5 hours
20‑25 °C
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
on MODULAR ANALYTICS E170, use only once
P273 Avoid release to the environment. cobas e 601, cobas e 602 and
cobas e 801 analyzers at 20‑25 °C
P280 Wear protective gloves. Store calibrators upright in order to prevent the calibrator solution from
Response: adhering to the snap‑cap.
P333 + P313 If skin irritation or rash occurs: Get medical Materials provided
advice/attention. ▪ CA 19‑9 CalSet, barcode card, calibrator barcode sheet, 4 empty
labeled snap-cap bottles, 2 x 6 bottle labels
P362 + P364 Take off contaminated clothing and wash it before reuse. Materials required (but not provided)
Disposal: ▪ 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles
P501 Dispose of contents/container to an approved waste ▪ MODULAR ANALYTICS E170 or cobas e immunoassay analyzers and
Elecsys CA 19‑9 assay reagents
disposal plant.
▪ Distilled or deionized water
Product safety labeling follows EU GHS guidance.

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CA 19-9 CalSet
See the assay Method Sheet and the operator’s manual for additionally
required materials.
Assay
Place the reconstituted calibrators (in the system-compatible bottles with
barcoded labels) in the sample zone.
Read in all the information necessary for calibrating the assay.
Ensure the calibrators are at 20‑25 °C prior to measurement.
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, 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 19‑9 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

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