PreciControl HbA1c Norm.05975115001.V4.En

05975115001V4.
PreciControl HbA1c norm

05479207 190 4 x 1mL Control
05991323 922 4 x 1mL Control (QCS)
English reagents.
Disposal of all waste material should be in accordance with local guidelines.
System information Safety data sheet available for professional user on request.
For use on Roche/Hitachicobasc analyzers the control code is 208.
For USA: For prescription use only.
For use on COBASINTEGRA analyzers the systemID is 0774774.
All human material should be considered potentially infectious. All products
For use on the Roche/Hitachicobasc513 analyzer* the control codes can derived from human blood are prepared exclusively from the blood of
be found in the following table: donors tested individually and shown to be free from HBsAg and antibodies
to HCV and HIV.
PCA1N The testing methods applied were FDA-approved or cleared in compliance
Code Short name with the European Directive 98/79/EC, AnnexII, ListA.
However, as no testing method can rule out the potential risk of infection
30001* PCA1NWS1 with absolute certainty, the material should be handled with the same level
of care as a patient specimen. In the event of exposure, the directives of the
30002* PCA1NWS2 responsible health authorities should be followed.1,2
30003* PCA1NHS1 Handling
30004* PCA1NHS2 The product is readyforuse. Mix carefully before use. Avoid the formation
Different codes have been assigned to distinguish between whole of foam.
blood(W) and hemolysate(H), and between S1 and S2 sample probe. Equilibrate the control to room temperature before use.
*not for use in the US The enclosed barcoded labels are intended exclusively for the cobasc
systems (except for the cobasc513 analyzer*) to identify the control.
Intended use Attach the barcoded labels to the tubes carrying the sample cups containing
PreciControlHbA1cnorm is for use in quality control by monitoring the control material.
accuracy and precision for the quantitative methods as specified in the *not for use in the US
value sheets.
Storage and stability
Summary
Store at 28C.
PreciControlHbA1cnorm is a liquid control based on hemolyzed human
blood. Criterion for the stability data stated by Roche:
The adjusted concentrations of the control components are usually in the Recovery within 10% of initial value.
normal range or at the normal/pathological threshold.
Stability:
Some methods specified in the relevant value sheet may not be available in
all countries. Unopened: Up to the stated expiration date at 28C.
Reagents working solutions After opening: 28days at 28C or 12weeks at
Reactive components in the liquid controls: (15)(25)C, provided that dispensing of the
Hemolyzed human blood control occurs without microbial contamination,
The concentrations of the components are lot-specific. The exact target e.g. by pouring out. Freeze only once.
values are given in the electronically available or enclosed value sheets. Store control tightly capped when not in use.
The values are also encoded in the enclosed control barcode sheets for Materials provided
COBASINTEGRA and cobasc111 analyzers.
For the cobasc analyzers (except for the cobasc111 analyzer) the values See Reagents working solutions section
are encoded in electronic files sent via the cobas link to the analyzers. Barcoded labels
Target values and ranges Materials required (but not provided)
The target values were determined using the method stated in the Roche system reagents and clinical chemistry analyzers
electronically available or enclosed value sheets. Determinations for Roche
methods were performed under strictly standardized conditions on Roche General laboratory equipment
analyzers using Roche system reagents and the Roche master calibrator. Assay
The target value specified is the mean of all values obtained. The Dispense the required volume into a sample cup and analyze in the same
corresponding control range is calculated as the target value 3standard way as patient samples.
deviations (the standard deviation being the value obtained from several
target value determinations). Results should be within the defined ranges. The controls should be run daily in parallel with patient samples and after
Each laboratory should establish corrective measures to be taken if values every calibration. Control intervals must be adapted to individual
fall outside the range. laboratorys requirements.
A clinically insignificant difference may be seen between the value(s) listed Follow the applicable government regulations and local guidelines for
on the value sheet and the value(s) obtained from the instrument readable quality control.
data. This is caused by: References
the rounding of value(s) during conversion from the unit in the 1 Occupational Safety and Health Standards: Bloodborne pathogens.
instrument readable data to the unit that is being used. (29CFR Part 1910.1030). Fed. Register.
the calculation of the ranges by the analyzer using the percentage 2 Directive 2000/54/EC of the European Parliament and Council of
values for the ranges encoded in the barcodes. 18September 2000 on the protection of workers from risks related to
The traceability of the target value is given in the respective Method Sheets exposure to biological agents at work.
for the system reagents to be used in combination with the recommended A point (period/stop) is always used in this Method Sheet as the decimal
calibrator. separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Precautions and warnings
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory
2016-06, V 4.0 English 1/2

05975115001V4.0
PreciControl HbA1c norm

Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 152231 standard.
Contents of kit
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, COBASC, PRECICONTROL and COBASINTEGRA 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.
2015, 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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05975115001V4.

PreciControl HbA1c norm

2016-06, V 4.0 English 1/2

PreciControl HbA1c norm

FOR US CUSTOMERS ONLY: LIMITED WARRANTY

Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim

2/2 2016-06, V 4.0 English

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