This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218080**Revised: January 2017 (5th edition)*Revised: August 2011 (4th edition)

This package insert must be read carefully prior to use.
Creatine kinase assay kit(Classification No.: 38503000)

produce creatine and ATP. ATP is converted toglucose-6-phosphate by the action of glucose inthepresenceof
hexokinase(HK).
Glucose-6-phosphateisconvertedto6-phosphogluconic acid by the action of
glucose-6-phosphate dehydrogenase (G-6-PD). At
the same time, oxidized NADP is converted toreduced NADPH, and the absorbance at 340 nm
increases. CK activity is determined by measuring
the velocity of NADPH production.

Pureauto S CK-LGeneral Precautions
1. This product is for in vitro diagnostic use, andmust not be used for any other purposes.
2. Clinicians should make a comprehensive clinicaldecision based on assay results in conjunction withclinical symptoms and other examination results.
3. This product should be used only as directed in thispackage insert. Reliability of results cannot beguaranteed if there are any deviations from theinstructions in this package insert.
4. If the reagent accidentally comes in contact witheyes and/or mouth, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
5. Carefully read the operating instructions for eachtype of automated analyzers prior to using thisproduct. Parameters for each type of analyzers areavailable, and can be requested from SEKISUIMEDICAL CO., LTD. if required.
6. Perform a quality control test prior to assay toensure accuracy.

Creatine phosphate + ADPCKCreatinine + ATP
Mg2+
HK
ATP + Glucose 2+ ADP + Glucose-6-phosphate
Mg
G-6-PD
Glucose-6-phosphate + NADP
6-Phosphogluconic acid + NADPH
2. Features
1) Final concentration of the principal ingredientmatches with the final concentration stipulated
in the JSCC Recommendation for EnzymeActivities.
2) Because the double kinetics method is used,
analytical results are not influenced byhemolysis.
3) Wide assay range.
Procedural Precautions ＊＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma may be used.
2) Storage of samples4)
If the isolated serum or plasma sample cannot
be tested on the same day, specimens should
be stored as follows:
2–10C: for tests within 1 week
≤ -20C: for tests after more than 1 week
Bring samples to room temperature (15–30C)
before use.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 20 mg/dL), conjugated bilirubin (up to 20mg/dL), hemoglobin (up to 500 mg/dL), ascorbic
acid (up to 50 mg/dL), or formazin turbidity (upto 3000 FTU).
3. Others
1) Always use Enzyme Calibrator Plus “Daiichi”
for calibration.
2) Precautions for assay range
If the activity of sample exceeds assay range,
dilute the sample with saline and repeat themeasurement.

Description (Kit Components) ＊＊Component: Ingredients
CK-L Enzyme Solution 1:
Hexokinase (derived from yeast)
Glucose-6-dehydrogenase(derivedfrom Leuconostoc)
Adenosine-5’-potassium diphosphate
Nicotinamide adenine dinucleotide
potassium phosphate (oxidized form)
D-Glucose
CK-L Substrate Solution 2:
Disodium creatine phosphate
Intended Use
Measurement of creatine kinase in serum orplasma
Creatine kinase (CK) is an enzyme that acts oncreatine phosphate and ADP to produce creatine andATP.
Because the skeletal muscle and myocardium have ahigh content of CK, it is considered to be useful forthe diagnosis of muscle disease and myocardial
infarction.
Various recommended methods of measuring theblood CK level, such as the GSCC and JSCC
methods, have been published recently. These areexpected to be useful for improving variations ofmeasurement among laboratories.

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): CK-L Enzyme Solution (1) is readyto use.
Reagent (2): CK-L Substrate Solution (2) isready to use.
2. Assay Procedure

Assay Principle
1. Assay Principle
CK acts on creatine phosphate and ADP to1

This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.
Sample + Reagent (1)5.0 μL160 μL
Reagent (2)
40 μL

37 C
107-293 sec
37 C
122-299 sec

2) Sodium azide is added as an antiseptic agent inthis product. Therefore, if the reagent comes in
accidentally contact with eyes, mouth or skin,rinse immediately with ample water as first aid,
and consult the doctor if required.
2. Precautions for use
1) This product should be stored as directed,
without freezing. Freezing can deteriorate thereagents, which can produce inaccurate results.
Therefore, avoid using the reagents which havebeen previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.
4) Do not perform the assay under direct sunlight
3. Precautions for Disposal
1) Before disposal, used samples and theircontainers must be immersed in sodium
hypochlorite solution at a concentration ofgreater than 0.1% for longer than 1 hour or
autoclaved at 121 ºC for 20 minutes.
2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such as
sodium hypochlorite solution at a concentrationof greater than 0.1%.
3) The reagents and treated samples should bediscarded as medical waste or industrial waste
according to the waste disposal regulations.
4) The reagents should be disposed of inaccordance with the Water Pollution Control act
or related regulations.
5) Sodium azide has been added as an antiseptic
agent in this product. It can react with lead orcopper pipes to produce the highly explosive
metal azide. Therefore, the reagent should beflushed with large amounts of water during
disposal.
4. Other precautions
Do not use the containers for other purposes.

Measurement(Absorbance I※)
Measurement(Absorbance II※)
Calculation ofactivity※

Absorbance I and II: The difference in absorbance
between 405 nm and 340 nm.
Calibration material: Enzyme Calibrator Plus
“Daiichi” (manufacture's assigned value)
Reagent blank: Purified water or saline

Assessment of Assay Results ＊＊1. Reference standard range5)
Male: 59–248 U/LFemale: 41–153 U/L
2. There may be reactions or interfering reactions
with non-target substances. If assay results appear
to be unreliable, repeat the measurement (ifnecessary, after dilution) or try another analyticalmethods.
＊＊

Performance ＊1. Sensitivity1) Reagent blank: change in absorbance being
equal to or lower than 0.005/min2) Sensitivity: The change of absorbance is0.194–0.290/min per 1000 U/L of CK activity.
2. Accuracy: 90–110 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 5 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range7): (On Hitachi 7170S
automated analyzer)
4–3000 U /L
5. Correlation7)
1) Serum N=50
r=0.999
y=1.03x–0.03
Control method: using an already approved invitro diagnostic product with method in line withthe JSCC Recommendation for Enzyme Activities
2) Plasma N=50
r=0.999
y=1.03x–0.89
Control method: using an already approved invitro diagnostic product with method in line with
the JSCC Recommendation for Enzyme Activities
6. Standard Material
Enzyme Calibrator Plus, the calibration material
used for this product, is in line with the JapaneseStandard for Certified Enzyme Reference
Materials.

Name
Package
CK-L Enzyme(1)
2 × 60mL
Solution 1
Pureauto S
CK-L
CK-L Substrate(2)
2 × 17mL
Solution 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.

Precautions for Use or Handling ＊＊1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled
as a material possibly infected with HIV, HBV,HCV, or other viruses. To prevent infection, use
disposable gloves and avoid mouth pipetting
during the test.

References ＊＊1) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 19, 184, 1990.
2) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 19, 189, 1990.
3) Osawa S.: Med Tech, 20, 1022, 1992.
4) Sasaki M. et al.: Sampling of constituents of theStorage and Shelf Life ＊＊1. Storage temperature: 2–8C
2. Shelf life: 8 months from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging2

human body, 193, Kodansha, 1972.
5) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 571,
Kanehara Shuppan, 2015.
6) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 25, 135, 1996.
7) In house data, SEKISUI MEDICAL CO., LTD.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan3