This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No.13A2X00197218079** 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)

Creatine kinase (CK) acts on creatine phosphateand ADP to produce creatine and ATP. ATPreacts with glucose in the presence of hexokinase(HK) to produce glucose-6-phosphate.
Glucose-6-phosphateisconverted
to6-phosphogluconic acid by the action ofglucose-6-phosphate dehydrogenase (G-6-PDH).
At the same time, NADP is converted to NADPH,
and the absorbance at 340 nm increases. CKactivity is determined by measuring the velocityof NADPH production.
CK
Creatine phosphate + ADP Creatine + ATP
Mg2+
HK
ATP + Glucose
ADP + Glucose-6-phosphate
Mg2+
G-6-PD
Glucose-6-phosphate + NADP
6-Phosphogluconic acid + NADPH
2. Features
1) Final concentration of the principal
ingredientmatcheswith
thefinalconcentration stipulated in the JSCC
Recommendation for Enzyme Activities.
2) Because the double kinetic method is used,
analytical results are not influenced byhemolysis.
3) Wide assay range.

QUALIGENT 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 be
guaranteed 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.
Description (Kit Components) ＊＊Component: Ingredients
CK-L Enzyme Solution 1:
Hexokinase (derived from yeast)
Glucose-6-dehydrogenase(derived from Leuconostoc)
Adenocin-5’-potassium
diphosphate
Nicotinamide
adeninedinucleotide potassium phosphate(oxidized)
D-Glucose
CK-L Substrate Solution 2:
Disodium creatine phosphate

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 (up to3000 FTU)
3. Others
1) Always use Enzyme Calibrator Plus “Daiichi”
for calibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

Intended Use
Measurement of creatine kinase in serum or
plasmaCreatine kinase (CK) is an enzyme that acts oncreatine phosphate and ADP to produce creatine andATP.
Because there is much CK in the skeletal muscle andmyocardium, it is considered to be useful for thediagnosis of muscle disease and myocardial
infarction.
Various recommended methods of measuring blood
CK such as GSCC and JSCC have recently been
published. They are expected to be useful for
improving differences among laboratories.

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): CK-L Enzyme Solution 1 is ready touse.
Reagent (2): CK-L Substrate Solution 2 is ready touse.

Assay Principle ＊＊1. Assay Principle1

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.
2) Sodium azide is added as an antiseptic agent in
the reagent in this product contains. Therefore,
if the reagent comes in accidentally contact witheyes, mouth or skin, rinse immediately withample 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 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 121ºC 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 is added as an antiseptic agent in
the reagent in this product contains. It can reactwith lead or copper pipes to produce the highly
explosive metal azide. Therefore, the reagent
should be flushed with large amounts of water
when disposing.
4. Other precautions
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge beforeuse.

2. Assay Procedure.This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.
Sample3.3 L37CMeasurement+ Reagent (1) ───▶
(Absorbance I※)
100 L107–293 sec+Measurement
37C
Reagent (2)───▶
(Absorbance II※)
25 L
122–299 sec───▶

※Calculation ofactivity

Absorbance I and II: The difference in absorbance
between 415 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 resultsappear to be unreliable, repeat the measurement(if necessary, after dilution) or try anotheranalytical methods.
Performance ＊1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.005/min
2) Sensitivity: The change of absorbance is0.194–0.290/min per 1000 U/L ofcreatine kinase 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 a Hitachi 9000 series
automated analyzer)
4–3000 U/L
5. Correlation7):
1) Serum N=80 r=0.999 y=1.03+0.0
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for Enzyme
Activities
2) Plasma N=70 r=0.999 y=1.03x–0.8
Control method: using an already approved invitro diagnostic product with method in linewith 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.

Storage and Shelf Life ＊＊1. Storage temperature: 2–10C
2. Shelf life: 8 months from the date of manufacture(The expiration date is printed on the outerpackage.)

Precautions for Use or Handling ＊＊1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled2

Packaging ＊＊Name

QUALIGENT CK-L

Package contents
CK-L Enzyme
Solution 1
Set
1 × 15.0 mL(Cassette for
Hitachi 9000
CK-L Substrateseries)
Solution 2
1 × 3.8 mL
CK-L Enzyme
L set
Solution 1(Set for1 × 46 mLHitachi
CK-L Substrate
LABOSPECT
Solution 2series)
1 × 12 mL

22References ＊＊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 thehuman body, 93, 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