ms_12017504122V13.

Insulin CalSet
12017504122 4 x 1.0 mL
For USA: Elecsys Insulin CalSet

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

Intended use Avoid foam formation in all reagents and sample types (specimens,
Insulin CalSet is used for calibrating the quantitative Elecsys Insulin assay calibrators and controls).
on the Elecsys and cobas e immunoassay analyzers. Handling
Summary Carefully dissolve the contents of one bottle by adding exactly 1.0 mL of
Insulin CalSet is a lyophilized bovine serum with added insulin in two distilled or deionized water and allow to stand closed for 15 minutes to
concentration ranges. reconstitute. Mix carefully, avoiding foam formation.
The CalSet can be used with all reagent lots. Transfer aliquots of the reconstituted calibrators into empty labeled
snap‑cap bottles (CalSet Vials). Attach the supplied labels to the additional
Reagents - working solutions bottles. Store the aliquots immediately at ‑20 °C (± 5 °C).
▪ INSULIN Cal1: 2 bottles, each for 1.0 mL of calibrator 1 Perform only one calibration procedure per aliquot.
▪ INSULIN Cal2: 2 bottles, each for 1.0 mL of calibrator 2 Please note for cobas e 602 and cobas e 801 analyzers: Both the vial
Insulin (human, recombinant from yeast) in two concentration ranges labels, and the additional labels (if available) contain 2 different barcodes.
(approximately 5 µU/mL or 35 pmol/L and approximately 300 µU/mL or Please turn the vial cap 180° into the correct position so that the barcode
2080 pmol/L) in a bovine serum matrix. between the yellow markers can be read by the system. Place the vial on
the analyzer as usual.
cobas e 801 analyzer: The exact lot‑specific calibrator values are encoded
in the electronic barcode and available via the cobas link. Storage and stability
All other analyzers: The exact lot‑specific calibrator values are encoded in Store at 2‑8 °C.
the barcode as well as printed on the enclosed (or electronically available) The lyophilized calibrators are stable up to the stated expiration date.
calibrator barcode sheet.
Calibrator values Stability of the reconstituted calibrators:
Traceability: The Elecsys Insulin assay has been standardized using the at ‑20 °C (± 5 °C) 3 months (freeze only once)
1st IRP WHO Reference Standard 66/304 (NIBSC).
on the analyzers at 20‑25 °C use only once
Precautions and warnings
Store calibrators upright in order to prevent the calibrator solution from
For in vitro diagnostic use for health care professionals. Exercise the adhering to the snap‑cap.
normal precautions required for handling all laboratory reagents.
Infectious or microbial waste: Materials provided
Warning: handle waste as potentially biohazardous material. Dispose of ▪ Insulin CalSet, barcode card, calibrator barcode sheet, 4 empty labeled
waste according to accepted laboratory instructions and procedures. snap‑cap bottles, 2 x 6 bottle labels
Environmental hazards: Materials required (but not provided)
Apply all relevant local disposal regulations to determine the safe disposal.
▪ 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles
Safety data sheet available for professional user on request.
▪ MODULAR ANALYTICS E170 or cobas e immunoassay analyzers and
For USA: Caution: Federal law restricts this device to sale by or on the Elecsys Insulin assay reagents
order of a physician.
This kit contains components classified as follows in accordance with the ▪ Distilled or deionized water
Regulation (EC) No. 1272/2008: 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.
Warning Ensure the calibrators are at 20‑25 °C prior to measurement.
H317 May cause an allergic skin reaction. For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets, the product
H319 Causes serious eye irritation. information and the Method Sheets of all necessary components (if
available in your country).
H412 Harmful to aquatic life with long lasting effects. 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
Prevention: a decimal numeral. Separators for thousands are not used.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray. Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
P273 Avoid release to the environment. State in which the user and/or the patient is established.
Symbols
P280 Wear protective gloves/ eye protection/ face protection. Roche Diagnostics uses the following symbols and signs in addition to
Response: those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
P333 + P313 If skin irritation or rash occurs: Get medical
Contents of kit
advice/attention.
Analyzers/Instruments on which reagents can be used
P337 + P313 If eye irritation persists: Get medical advice/attention.
Reagent
P362 + P364 Take off contaminated clothing and wash it before reuse. Calibrator
Product safety labeling follows EU GHS guidance.

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Insulin CalSet
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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