03121348001V5.

Precipath PUC
  03121291 122 4 x 3 mL Control

English Infectious or microbial waste:

Warning: handle waste as potentially biohazardous material. Dispose of
System information waste according to accepted laboratory instructions and procedures.
For use on Roche/Hitachi MODULAR and cobas c analyzers the control
code is 241. Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.
For use on COBAS INTEGRA analyzers the system ID is 07 6757 3.
Safety data sheet available for professional user on request.
Intended use For USA: Caution: Federal law restricts this device to sale by or on the
Precipath PUC (Proteins in Urine/CSF) is for use in quality control by order of a physician.
monitoring accuracy and precision for the quantitative methods as specified All human material should be considered potentially infectious. All products
in the value sheets. derived from human blood are prepared exclusively from the blood of
Summary donors tested individually and shown to be free from HBsAg and antibodies
Precipath PUC is a liquid ready‑for‑use control based on a buffered to HCV and HIV. The testing methods use assays that have been approved
aqueous solution. The adjusted concentrations of the control components by the FDA or that are in compliance with the legal rules applicable to
are usually in the pathological range. placing in vitro diagnostic medical devices for human use on the market in
the European Union.
Some methods specified in the relevant value sheet may not be available in However, as no testing method can rule out the potential risk of infection
all countries. 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
Reactive components: responsible health authorities should be followed.1,2
HEPES buffer: 20 mmol/L, pH 7.5, and chemical additives and material of Handling
biological origin as specified. The product is ready‑for‑use. Mix carefully before use. Avoid the formation
The origin of the biological additives is as follows: of foam.
The enclosed barcoded labels are intended exclusively for the
Analyte Origin Roche/Hitachi MODULAR analyzers and cobas c systems to identify the
Albumin human serum control. Attach the barcoded labels to the tubes carrying the sample cups
containing the control material.
α1-Microglobulin human urine
Storage and stability
Immunoglobulin A human serum Store at 2‑8 °C.
Immunoglobulin G human serum Criterion for the stability data stated by Roche:
Immunoglobulin M human serum Recovery within ± 10 % of initial value.
Total protein human serum/sheep serum Stability:
Non-reactive components: Unopened: up to the stated expiration date at 2‑8 °C
Preservatives and stabilizers After opening: 4 weeks at 2‑8 °C, provided that dispensing of the
The concentrations and activities of the components are lot‑specific. The control occurs without microbial contamination, e.g.
exact target values are given in the electronically available or enclosed by pouring out.
value sheets.
Store control tightly capped when not in use.
The values are also encoded in the enclosed control barcode sheets for
Roche/Hitachi MODULAR, COBAS INTEGRA and cobas c 111 analyzers. Materials provided
For the cobas c analyzers (except for the cobas c 111 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 electronically
available or enclosed value sheets. Determinations for Roche methods ▪ Roche system reagents and clinical chemistry analyzers
were performed under strictly standardized conditions on Roche analyzers ▪ General laboratory equipment
using Roche system reagents and the Roche master calibrator. The target
value specified is the median of all values obtained. The corresponding Assay
control range is calculated as the target value ± 3 standard deviations (the Dispense the required volume into a sample cup and analyze in the same
standard deviation being the value obtained from several target value way as patient samples.
determinations). Results should be within the defined ranges. Each The controls should be run daily in parallel with patient samples and after
laboratory should establish corrective measures to be taken if values fall every calibration. Control intervals must be adapted to individual
outside the range. laboratory’s 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. (29 CFR 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. 18 September 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
calibrator. 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
Precautions and warnings a decimal numeral. Separators for thousands are not used.
For in vitro diagnostic use for health care professionals. Exercise the Any serious incident that has occurred in relation to the device shall be
normal precautions required for handling all laboratory reagents. reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.

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Precipath PUC
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
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 C, COBAS INTEGRA and PRECIPATH 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.
© 2021, 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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