Item Brochure
osom
iFOBT Control Set
®
F O R I N V I T R O D I A G N O S T I C U S E O N L Y
INTENDED USE
OSOM iFOBT Control includes a Positive Control containing stabilized human hemoglobin
and a Negative Control containing a buffer. OSOM iFOBT Controls should only be used
with OSOM iFOBT tests.
WARNINGS AND PRECAUTIONS
• The Positive Control is the vial with the red cap and the Negative Control is the vial
with white cap. Do not exchange the caps of the vials.
• The OSOM iFOBT Positive and Negative Control Vials should be stored at 2
o
C- 30
o
C and
can be used until the labeled expiration date.
• For in vitro diagnostics use and professional and laboratory use only.
• Do not use the controls beyond the expiration dates.
• Handle as if capable of transmitting hepititis. Not for internal use by humans or animals.
REAGENTS
OSOM iFOBT Control Positive Control (1.0 ml) is liquid and ready to use. WARNING:
Contains Human serum with 0.1% Sodium azide. Contents sterile until opened.
OSOM iFOBT Control Negative Control (1.0 ml) is liquid and ready to use. WARNING:
Contains Human serum with 0.1% Sodium azide. Contents sterile until opened.
Directions for Use
• Allow the test and the controls to equilibrate room temperature 59 -86
o
F (15- 30
o
C)
prior to testing.
• To begin the testing, open the sealed pouch of the OSOM iFOBT test by tearing the pouch.
Remove the test cassette from the pouch and use it as soon as possible.
• Squeeze 3 drops of the Positive Control in to the sample well of the OSOM iFOBT Cassettes.
• With a new cassette, repeat the same procedure for the Negative Control.
• The results should be read at five minutes. DO NOT INTERPRET RESULTS AFTER 10 MINUTES.
EXPECTED RESULTS
• Read results at 5 minutes
• Do not read results beyond 10 minutes
• Even if a very faint color band appears in the test region, it should be considered a
positive result
Negative Control Results
Only one colored band appears on the control region. No apparent band on the
test region.
Positive Control Results
Color bands appears on the control and test regions. Even if a very faint colored
band appears in the test region it should be considered as positive result.
.
P-55740 06/15
OSOM
®
logo is a registered U.S. trademark of Sekisui Diagnostics, LLC. © 2015 Sekisui Diagnostics, LLC. All rights reserved.
Invalid
No line appears in the control region “C”; the test should be voided since an improper
test procedure may have been per formed or deterioration of positive or negative
control reagents may have occured. This is due to the internal control built in which a
distinct control region (C) line should always appear. Repeat the test using a new device.
If the problem persists, discontinue using the test kit immediately and contact
Sekisui Diagnostics Technical Support at 800-332-1042.
Waste Disposal Method
The OSOM iFOBT Control contains sodium azide as a preservative. Best disposal method
for biological material containing sodium azide is to wash it down the sewer with large
excess of water. Disposal should be made in accordance with existing disposal practices.
Observe all Federal, State and Local laws.
BIOHAZARD
Caution: Human source material used in the preparation has been found non reactive for
HBsAg when tested by RIA, and also negative for HIV-1 antibody when tested by ELISA.
However, no known test method can assure that a product derived from human sources
does not contain hepatitis or HIV-1 viruses.
MANUFACTURED FOR:
6659 Top Gun Street
San Diego CA, 92121
800-332-1042
www.sekisuidiagnostics.com
D I A G N O S T I C S
1000
.
Instructions For Use (Read)
For In V itro Diagnostic Use
Lot Number
Expiration Date
Store At
Do Not Freeze
Catalog Number
.
KEY TO COMPONENTS LABELING
.
I V D
L O T
R E F
PRINCETON BIOMEDITECH CORPORATION
4242 U.S. Hwy 1, Monmouth Jct.
New Jersey 08852, U.S.A.
1-732-274-1000
www.pbmc.com