HORIBA lnstruments lncorporated
POINTE
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5449 Research Drive, Canton, tv4l 48'i88
Phone: 734-487-8300; (800) aa5-9353
Chemistry Controls
Level I and Level ll
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Lot: 303701, Exp.: 2026-12-31
Lot: 315001, Exp; 2027 -04-30
The Expected Values and ranges are target values derived from inter
lntended 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
commoniy of interest in a general chemistry control, including common drugs
and thyroids. The assayed multi-analyte control product is packaged with
one revet of analytes Rx Only
Produet Description
The quality control material ls prepared from human serum with enzymes,
nonprotern constituents. non-human proteln and bacleriostatic agents
added The constituents were adlusted 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 unil
used was tested by FDA-approved methods and found nonreactive for
hepatitis B w*ace antigen (HBsAg) Hepatitis C (HCV), and HIV 1 and HIV
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
2.
Disease Control/National lnstiiute
of Health Manual, "Biosafety
Microbiological and Biomedical Laboratoies,
1
in
999.'
This product contains less then 0.170 sodium azide that may react with lead
and copper plumbing to form potentially explosive metal aztdes. 0n disposal,
flush with large volumes of water to prevent azide build-up,
Storage and Stability
Ensure that you tightly seal the vials after reconstitLrtion and use io 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 lighl.
laboratory data. The expected range values include variations of instrurent
and laboratory handling. The assay values were obtained usrng in date
POINTE reagents available at the time of testing, Updates to the sted
values may be made based upon additional data that becomes availabre or,
if necessitated by a modification to a test method. The mean values
established for your laboratory should fall within the ranges shown" 1n
Expected Values; however laboratory means may vary during the life c'f the
contro{ Each laboratory shculC establish its own mean and prec,sicit
parameters,
Limitations
The results obtained using the quality controi material are dependant tpon
several factorsi erroneous results can occur from improper sto,age,
reconstitution errors, inadequate mixing, or sample handling errors
associated with instrument or assay procedures, Do not use the q,rality
control material if there is visible evidence of microbial growth in the via or a
iack of vacuum when opening the vial for the first time For more information
about procedural limitations, refer to your instrument manuai or assay
product insert,
Disposing of Materials
Dispose of hazardous or biologically contaminated materials accordilg to
your institution's practices, Discard all materials in a safe and accep'able
manner that is in compliance with all country, state, and local requireme,ts
Technical Assistance
For technical assistance and customer service contact P0INTE at 800-a459853 or 800-757-531 3 or by fax at 734-483-1 592
Symbol Key
Stability
Unreconstituted
z-a-v
Refer to the label on each vial and on the
package for the expiration date
Reconstituted
o aon
7 days
Exceptions: Bilirubin and Alkaline
Phosphatase which are stable 48hrs.
\la-JacrLreo 'or ioRlBA oOlN-E
:,E.:;i:g."
B,and
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!(
ny
Consult instructions for
ce
,r*
IIdliFl
use
Rx Only: Prescription Use On
y
nuthorized reoresentative in the Eurooean com'nunitv
ALP may increase with time.
General lnstructions for Use
Use the quality control material according to the directions accompanying the
instrument or the assay prccedui'e used, Ti'eat ihe quaiity conuoi maieriai in
the same manner as patient samples.
1.
2.
a
Manufactured for HORIBA: POINTE Brand
I\,1l 48188
5449 Research Drive, Canton,
nL^l^
^ ^
uuu{15 5.d.
Remove the screw cap and gently remove the rubber stopper from the
vial
Boulevard Generat Wahis 53
1 030 Brussels, BELGTU[/
Pipette exactly 5 0 mL of distilled or deionized water to the vial using a
volumetric pipette.
emari: marl@obelis
4.
Replace the stopper in the vial, allow the vial to sit for 10 minutes,
Gently invert the vial three (3) times and swirl until the contents are
5.
homogenous.
Record the results according to your quality assurance program
J,
Expected Results
Refer to the Expected Values table supplied for assay mean and ranges.
Before use, verify that the vial lot number corresponds to the lot number
listed on the Expected Values table
itv0
(YYYY-MM-DD) if6il Lot ano batch code
d Manufactu,er
|RFFI Catalog number
lE6l r, vitro diagnostic medical device f Temperature limitation
!
Storage
I
lrrr c7592 I
ret \32)2.732.59.54,Fax.\32\2/326003
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Certified to Perform
P0INTE certifies that all of our products are manufactured according to
specified parameters. Any product not meeting specifications through their
listed expiration date will be remedied immediate{y without charge,
POINTE Chemistry Controls
\
LEVEL land IICONTROL
EXPECTEDVALUES
ANALYTE
Beckman
Hitachi
AU 400 I 640
717
BS-200
2.?
r
0.2
x0 2
80 x24
23 t0,2
2.1
x24
ALT (SGPT)
86t26
49t10
49t10
57 x11
Amylase
208
t
191 x57
251
AST (SGOT)
65r13
dtt tt
61 x12
t
0.6 t
0.4
0.4
0,4
0.7
Alk Phos
Direct Bilirubin
Total Bilirubin
BUN
,*
Pointe C2000
/ Mindray
0.5
62
9,6
r
1.0
Calcium (AR.lll)
9.8
t
'1.0
t
0.4
r 0,4
1l.t I
x2
13
Calcium (CPC)
8.5
r
8Q
0.6
t75
t
0,4
0.8 + 0.4
Carbon Dioxide
CK/CPK
Creatinine
BS-480
r11
111
r
104
1.05
t
31
0.30
t '10
9t5
100
104
1.01
r
t
0.3
85t26
51t10
101
t
t
202
2'19
66
59x12
t 0.4
07t04
0.6
1.0
31
0.30
t
'110
11
'10t5
x37
123
0.86
t
0.30
o+(
116r35
45x14
41 x12
+t =
Glucose Hex
93t9
80r8
82t8
79t8
80r8
83tB
60t18
qvt
rc
48=14
54:'10
t
16
76
t
15
79t16
15t0.2
1,5
t
0.2
t
100
t
20
1.5r02
109 t22
0.4
1.5
0.4
4.1 t0.4
Glucose Ox
tL
U/L
t4tu.t
g/dl
t27
U/L
52
r
10
U/L
t61
63t13
214
x64
UIL
t
.1 t
ol ! ll
0.4
0.6
t0.4
mg/dl
'1
0.4
0.8
r
mg/dl
r
1.0
98t10
x5
117
t35
'1.36
t
0.30
60
t
18
81
rB
80r8
0.4
r2
13
90r1.0
t
13
78
98t20
101
mg/dl
89t4
luot ]l
mEq/L
9t5
mEq/L
Magnesium
17 xA.4
Phosphorus
3.7
t
3.5 t
20
113t34
U/L
t
0.30
mgldl
45
t
14
U/L
83t8
mg/dl
t8
ms/dl
81
E2. IA
mgiCl
69t14
74+15
pg/dl
1.5 x0,2
mmol/L
102
x20
UiL
U/L
t0.4
1.5
0,4
0,4
t
3.8 t
1.5
t
0.4
t
3.8 t
1.4
0.4
1.5
t
0.4
0.4
3.8
t
r 0.5
126t4
3.7
Potassium
Sodium
x64
TIBC direct
254
Total Protein
4.2 x0.4
t 58
3.4 t 0,3
253
t
63
3.4
t
0.3
79 xZA
78 x20
233
'l
1+A?
82 x21
80t20
r
t 37
4,0 t 0,7
ulBc
Uric Acid
mg/dl
'1.03
Lipase (color)
Trig-GPO
mg/dl
mg/dl
67
Lactate
LDH
mg/dl
94t10
HDL PEG)
lron
U/L
0.7
11
089r030
40t12
86t1.7
86
9.3t10
89t4
110t11
Units
30
8.9
t
General
Assay Range
52x10
tJ!t
'1.0
9.1
6t5
t
:.A3
GGTP
HDL (auto)
Pointe 180
2.5
2.7
x2
13
Chloride
Cholesterol
Mindray
8.6r17
Acid Phos
Albumin
LOT: 303701 EXP.: 2026-12-31
LEVEL I CONTROL
72l
18
146
4,5
0,8
4.8
t
0.8
4.7
t
0.8
0.4
mg/dl
3.7t05
mEq/L
126x4
x62
mEq/L
247
2.7 x0,3
4,7
r
0.8
mg/dl
3.4
t
0.3
78 x2A
pgldi
gldl
mg/d{
146 x37
pg/dl
t
0.8
mg/dl
7/23
P803-C7592-01
4.5
Rev:
EXPECTED VALUIS
AIIALYTT
LTVTL iICONTROL
HitachiTlI
LOTI 315001 EXp
Fointe C2S*C
i Mindray
S{indray
General
B5-?00
8$-48CI
Assay Range
Units
Acid Phos
Aihumrr
,qih Phs$
AtT ISGFIi
I
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:
:.,:
ASi iscc;i
l:reel 8:lir*h;*
iotai Bilirubia
,14
2&
.:i
.
It)l
giJli
"*
Caic
j*m
i.1 1 : '.
'::t..
Chloride
Cnolesteic
,
i
! 1!:
Carbon 0iaxide
!
!"::
'l!: ..
c{icPX
Creatinine
uu tP
ifi:.rrr-
:i-.-..
G;uccse hex
Girrc*se 0x
r..!ili, iai.Jtsl
."..'t
H0L {PEG}
Iron
' t'
Lacisl€
- :':-
..i'1
Llpase icei0ri
Sagresrsm
-:!,[,
,i::..,l:
Pl'iosSlrcrus
Potassium
:,:,i:.i:
Sodiunr
:l8C diract
Iqtai Prcletr
l:'
_'
i!
:.1+li
-:::,1
i rrg-GF*
iiiu(*
.:_-,
Uric 4crC
:: ,r t:
i=.
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2027.04"30