Intended Use
For In Vitro Diagnostic Use only.
The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents
commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes.

Product Description
The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents
added. The constituents were adjusted to the levels listed in Expected Values.

Precautions
BIOHAZARD: Human source material. Handle as if potentially infectious. Human serum was used in the manufacture of this product. Each donor unit used was tested by FDA-approved methods and found nonreactive for hepatitis B surface antigen (HBsAg), Hepatitis C (HCV), and HIV 1 and HIV 2. Because no known test method can offer complete assurance that infectious agents are absent, all products containing human source material should be handled in accordance with recommendations from Centers for Disease Control/National Institute of Health Manual, “Biosafety in Microbiological and Biomedical Laboratories, 1999.”

Storage and Stability
Ensure that you tightly seal the vials after reconstitution and use to prevent evaporation during storage. Ensure that you store the vials upright to
prevent spills or leakage. CK and Bilirubin are sensitive to light. Store the vials away from light.

Storage Stability
Unreconstituted 2-8°C Refer to the label on each vial and on the package for the expiration date.
Reconstituted 2-8°C 7 days
Exceptions: ACP 3 days; ALT and ALP
5 days; ALP may increase with time.

General Instructions for Use
Use the quality control material according to the directions accompanying the instrument or the assay procedure used. Treat the quality control material in the same manner as patient samples.

1. Remove the screw cap and gently remove the rubber stopper from the vial.
2. Pipette exactly 5.0 mL of distilled or deionized water to the vial using a volumetric pipette.
3. Replace the stopper in the vial, allow the vial to sit for 10 minutes.
4. Gently invert the vial three (3) times and swirl until the contents are homogenous.
5. Record the results according to your quality assurance program.

Expected Results
Refer to the Expected Results assay sheets supplied for mean and range value assignments. Verify vial lot number with those on the enclosed assay sheets.
The assay values and expected ranges are target values derived from inter laboratory data. The expected range values include variations of instrument and laboratory handling. The assay values were obtained using in-date
Pointe Scientific reagents available at the time of testing. Updates to the
listed values may be made based upon additional data that becomes
available or, if necessitated by a modification to a test method. The mean
values established for your laboratory should fall within the ranges shown in
Expected Results; however laboratory means may vary during the life of the
control. Each laboratory should establish its own mean and precision
parameters.
Limitations
The results obtained using the quality control material depends on several
factors: erroneous results can occur from improper storage, reconstitution
errors, inadequate mixing, or sample handling errors associated with
instrument or assay procedures. Do not use the quality control material if
there is visible evidence of microbial growth in the vial or a lack of vacuum
when opening the vial for the first time. For more information about
procedural limitations, refer to your instrument manual or assay product
insert.
Disposing of Materials
Dispose of hazardous or biologically contaminated materials according to
your institution’s practices. Discard all materials in a safe and acceptable
manner that is in compliance with all country, state, and local requirements.
Technical Assistance
For technical assistance and customer service contact Pointe Scientific, Inc.
at 800-445-9853 or 800-757-5313 or by fax at 734-483-1592.
C7592-100
603304 and 603305
1/2009
Manufactured for
Pointe Scientific, Inc.
Manufactured for Pointe Scientific, Inc.
5449 Research Drive Canton, MI 48188
"European Authorized Representative"
(O.E.A.R.C.) Av. De Tervueren 34 bte44 B-1040
Brussels, Belgium