04714768001V6.

TDM Control Set

04521536 190 2 x 5mL Control LevelI
2 x 5mL Control LevelII
2 x 5mL Control LevelIII

English Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
System information
For use on Roche/HitachiMODULAR and cobasc analyzers the control All human material should be considered potentially infectious. All products
codes are: derived from human blood are prepared exclusively from the blood of
donors tested individually and shown to be free from HBsAg and antibodies
Level I TDMC1 Code 310 to HCV and HIV.
The testing methods applied were FDA-approved or cleared in compliance
Level II TDMC2 Code 311 with the European Directive 98/79/EC, AnnexII, ListA.
Level III TDMC3 Code 312 However, as no testing method can rule out the potential risk of infection
with absolute certainty, the material should be handled with the same level
For use on COBASINTEGRA analyzers the system IDs are: of care as a patient specimen. In the event of exposure, the directives of the
responsible health authorities should be followed.1,2
Level I TDMC1 systemID 0769002 For US users only:
Level II TDMC2 systemID 0769010 Warning: This reagent contains carbamazepine, phenobarbital, phenytoin,
primidone and valproic acid, substances known to the State of California to
Level III TDMC3 systemID 0769029 cause cancer or reproductive harm.
Intended use Handling
The TDMControlSet is for use in quality control by monitoring accuracy The product is readyforuse. Prior to use swirl bottle carefully to obtain a
and precision for the quantitative method as specified in the value sheets. homogenous solution. Record the date that the bottle was opened on the
Summary relevant bottle label.
The TDMControlSet consists of 3 liquid ready-for-use controls based on The enclosed barcoded labels are intended exclusively for the
human serum. Roche/HitachiMODULAR analyzers and cobasc systems to identify the
control. Attach the barcoded labels to the tubes carrying the sample cups
The adjusted concentrations of the control components are usually in the containing the control material.
normal range or at the normal/pathological threshold.
Some methods specified in the relevant value sheet may not be available in Storage and stability
all countries. Store at 28C.
Reagents working solutions Stability:
Reactive components: Unopened: up to the stated expiration date at 28C
Human serum with added therapeutic drugs After opening: 12months, or until the printed expiration date,
Non-reactive components: whichever comes first, at 28C
Preservative and stabilizer.
Store controls tightly capped when not in use.
The concentrations of the control components are lotspecific. The exact
target values are given in the electronically available or enclosed value Materials provided
sheets. See Reagents working solutions section
The values are also encoded in the enclosed control barcode sheets for Barcoded labels
Roche/HitachiMODULAR and COBASINTEGRA analyzers.
Materials required (but not provided)
For the cobasc analyzers (except for the cobasc111 analyzer) the values
are encoded in electronic files sent via the cobas link to the analyzers. Roche system reagents and clinical chemistry analyzers
Target values and ranges General laboratory equipment
The target values were determined using the method stated in the Assay
electronically available or enclosed value sheets. Determinations for Roche Dispense the required volume into a sample cup and analyze in the same
methods were performed under strictly standardized conditions on Roche way as patient samples.
analyzers using Roche system reagents. The target value specified is the
mean of all values obtained. The corresponding control range is calculated The controls should be run daily in parallel with patient samples and after
as the target value 3standard deviations (the standard deviation being every calibration. Control intervals must be adapted to individual
the value obtained from several target value determinations). Results laboratorys requirements.
should be within the defined ranges. Each laboratory should establish Follow the applicable government regulations and local guidelines for
corrective measures to be taken if values fall outside the range. quality control.
A clinically insignificant difference may be seen between the value(s) listed References
on the value sheet and the value(s) obtained from the instrument readable 1 Occupational Safety and Health Standards: Bloodborne pathogens.
data. This is caused by: (29CFR Part 1910.1030). Fed. Register.
the rounding of value(s) during conversion from the unit in the 2 Directive 2000/54/EC of the European Parliament and Council of
instrument readable data to the unit that is being used. 18September 2000 on the protection of workers from risks related to
the calculation of the ranges by the analyzer using the percentage exposure to biological agents at work.
values for the ranges encoded in the barcodes. A point (period/stop) is always used in this Method Sheet as the decimal
The traceability of the target value is given in the respective Method Sheets separator to mark the border between the integral and the fractional parts of
for the system reagents to be used in combination with the recommended a decimal numeral. Separators for thousands are not used.
calibrator.
Symbols
Precautions and warnings Roche Diagnostics uses the following symbols and signs in addition to
For in vitro diagnostic use. those listed in the ISO 152231 standard.
Exercise the normal precautions required for handling all laboratory
reagents. Contents of kit

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04714768001V6.0

TDM Control Set

Volume after reconstitution or mixing

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, COBASC, COBASINTEGRA and MODULAR are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Significant additions or changes are indicated by a change bar in the margin.
2013, Roche Diagnostics

Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim

www.roche.com
Distribution in USA by:
Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

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