Blood sample window

Proper blood application

Insufficient blood application

*Please ensure that the blood sample window is

completely filled with blood.

If it is not completely filled, do not attempt to add a

second blood sample; instead, repeat the test with a

new test strip.

*If your measured blood glucose value is below 50

mg/dL (2.8 mmol/L) or above 250 mg/dL (14 mmol/L),

please contact your healthcare professional.

Sample Volume: ~0,8 µL

Compatibility

These blood glucose test strips are intended for use only with the Novacheck® LM-602 blood glucose

meter.

Blood Glucose Test Strips:

Intended purpose: Novacheck® blood glucose test strips are intended for self-testing by people with

diabetes and for use by healthcare professionals to monitor glucose levels in whole blood.

Warning: Choking hazard: small parts. Keep out of reach of children under 3 years of age.

Introduction: Regular blood glucose testing can help you manage diabetes more effectively. Clinical

studies have shown that keeping blood glucose levels close to the target range, together with guid-

ance from your healthcare professional, may help prevent or delay diabetes-related complications

Package contents and disposal

The package contains test strips and instructions for use. Dispose of used test strips in accordance with local

regulations. For questions, please contact Novacheck®.

Note: The strips contain small amounts of reagents.

Performing a blood glucose test

Note: No coding is required.

If you have poor blood circulation, self-testing may not be appropriate.

Consult your healthcare professional.

Wash your hands with warm, soapy water. Rinse thoroughly and dry.

*Prepare your lancing device.

*Check the expiration date on the test strip vial. Do not use expired test strips.

*Insert a test strip into the meter.

*Use the lancing device to obtain a drop of blood.

*Touch the blood drop to the front edge of the yellow sample window.

The meter will start counting down from 5.

*The meter displays results in the range of 20–600 mg/dL (1.1–33.3 mmol/L).

*Storage: Store the test strips at 4°C to 32°C.

*Store the test strips only in the original vial. Close the vial cap immediately and tightly after

removing a test strip.

*Wash and dry your hands thoroughly before using the test strips.

*Do not use test strips after the expiration date. The expiration date is printed on the vial label and

on the test strip box.

*Use the test strips within 6 months after first opening the vial. Record the date you first opened

the vial on the box (or in the space provided).

*If your meter or test strips are moved from one temperature to another, wait at least 30 minutes

for them to reach room temperature before testing. The operating temperature range for the

Novacheck® blood glucose meter is specified in the user manual.

*Test strips are single-use only. Do not reuse a test strip.

After opening the test strip vial, ensure the vial cap is tightly closed. Do not use the test strips if

the vial was left open or the cap was not securely closed, or if the product appears to be missing,

damaged, or broken. Contact us for assistance: +90 342 502 27 27 or info@novadiag.com

Test procedure: Refer to the Novacheck® user manual for detailed instructions.

Test results: The meter is programmed to display results in mg/dL or mmol/L.

Blood Glucose Value In Adults¹

(In capillary whole blood measurement)

Without diabetes With Diabetes

Fasting ≤100 mg/dl (5,6 mmol/l) ≥126mg/dl (7,0 mmol/l)

2 hours after a meal ≤140 mg/dl (7,8 mmol/l) ≥200 mg/dl (11,1 mmol/l)

1:T1R. Landgraf et al., 2013: Praxisempfehlungen DDG/ DGIM;

2:Diabetologie und Sto wechsel;ieme Verlag

Note: For information only. This table is not intended for diagnosis. Always follow your

healthcare professional’s advice.

Comparison Options: Novacheck® system is designed for use with venous and

capillary whole blood. Comparison

with a laboratory method should be performed simultaneously with aliquots from

the same sample.

Note: Blood sugar concentrations drop rapidly due to glycolysis ( per hour 5-7 % )²

If your blood glucose level is below 50 mg/dL, seek medical attention immediately.

If your blood glucose level is above 250 mg/dL, contact your healthcare professional immediately.

Always consult your healthcare professional before making any changes to your medication based

on Novacheck® test results.

Chemical Composition: FAD Glucose dehydrogenase (Aspergillus spm2,0 / Test strip) %35,6, Potassium ferricyanide

% 41, nonreactive substances % 23,4

Performance features

1. Accuracy: Novacheck® LM-602 was compared with the YSI 2500 biochemical analyzer using

capillary whole blood samples collected simultaneously from 100 subjects.

1.1 Acceptance criteria: According to EN ISO 15197:2015, Clause 6.3 (reference measurement

procedure: YSI 2500), the acceptance criteria are as follows (see EN ISO 15197:2015, 6.3.3):

a) 95% of individual glucose results shall be within: ±15 mg/dL (±0.83 mmol/L) of the results of the

manufacturer’s measurement procedure at glucose concentrations <100 mg/dL (5.55 mmol/L); and

±15% of the results of the manufacturer’s measurement procedure at glucose concentrations ≥100

mg/dL (5.55 mmol/L).

b) 99% of individual glucose measured values shall fall within Consensus Error Grid (CEG) zones A

and B for type 1 diabetes.

Note: Novacheck blood glucose monitoring system results are calibrated against the YSI 2500 refer-

ence measurement procedure. The YSI 2500 analyzer is calibrated using a standard solution con-

taining 180 mg/dL (10.0 mmol/L) glucose.

Limitations:

1- Anticoagulants / Preservatives: Whole blood samples may be collected by healthcare profes-

sionals in test tubes containing heparin. Do not use other anticoagulants or preservatives unless their

compatibility has been verified.

2- Hematocrit: Novacheck® test strip results are not significantly affected by hematocrit levels within

the range of 20–60%.

3- Interfering substances (Interactions): The Novacheck® system has been tested with the follow-

ing substances that may be present due to therapeutic treatments: creatine, xylose, maltose, uric

acid, galactose, cholesterol, ibuprofen, triglycerides, EDTA-K2, heparin, gentisate, methyldopa, sali-

cylic acid, tolbutamide, icodextrin, hemoglobin.

At the highest concentration tested (maximum therapeutic concentration), no interference was

observed for these substances. The following substances may cause deviation in measurement

results at high concentrations: acetaminophen, bilirubin, tolazamide, dopamine, levodopa, pralidox-

ime, ascorbate (ascorbic acid)

Safety information

*For in vitro diagnostic use only. For external use only. Do not swallow.

*Potential biohazard: Healthcare professionals or individuals who use this system on more than one

patient must follow the infection control procedures approved by their institution. All items that come

into contact with human blood should be handled as potentially infectious and disposed of in accord-

ance with local regulations and institutional procedures.

Users must follow applicable guidelines for preventing blood-borne infections when handling poten-

tially infectious human samples in healthcare settings.

*Any serious incident that has occurred in relation to the device should be reported to the manufactur-

er and the competent authority of the Member State in which the user and/or patient is established.

Evaluation Results

As a result of tables and graphs, the accuracy of the blood glucose monitoring system meets the criteria of A and B

specified in EN ISO15197: 2015, 6.3.3 all data appeared to be in the A and B regions of the Consensus Error Grid.

Measurement Accuracy

1-1.Measurement Repeatability

Reference deviation of the stability criteria(See: EN ISO15197,6.3.3 ) ±15mg/dL(±0,83mmol/L) glicose concentration

< 5.55 mmol/L (< 100 mg/dl) and glucose concentration within ±15% ≥5.55 mmol/dl (100 mg/dl).

ﬀerences

Reference value

tesng results

reference values

1-2. Result:

-Number of samples 600

System accuracy results for glucose concentrations less than 100 mg/ dl

± 5 mg/dl

(0,28 mmol/L)

within

± 10 mg/dl

(0,56 mmol/L)

± 15 mg/dL

(0,83 mmol/L)

145/192( %76) 184/192( %96) 186/192( %97)

System accuracy results for glucose concentrations equal to or above 100 mg/ dl

± 5 mg/dl

(0,28 mmol/L)

± 10 mg/dl

(0,56 mmol/L)

± 15 mg/dl

(0,83 mmol/L)

311/408( %76) 394/408( %96) 400/408( %98)

±15 mg/dl or ±15 %

586/600 (%98)

Test Results: Capillary whole blood samples were taken from 100 different subjects as seen in the table below.

%48 of men; women are % 52.

Order Glucose Concentration

mmol/L(mg/dL)

Percent of Samples%

1 ≤2.77( ≤50) 5

2 >2.77-4.44(>50-80) 15

3 >4.44-6.66(>80-120) 20

4 >6.66-11.10(120-200) 30

5 >11.10-16.65(>200-300) 15

6 >16.65-22.20(>300-400) 10

7 >22.20(>400) 5

within within

withinwithinwithin

1-2.Measurement Results

Statistical Data

Blood Sample

a1 a2 a3 a4 a5

AVG 1.4 4.0 8.1 13.1 18.3

0.09 0.14 0.11 0.20 0.25

6.1% 3.6% 1.4% 1.5% 1.3%

1-3 Evaluation Results:

The intermediate measurement accuracy of this blood glucose monitoring system meets our company’s acceptance

criteria.

Interim Measurement Accuracy

2-2. Interim Measurement Results

Statistical

Data

Quality Control Fluid Number

a1 a2 a3

AVG 2.5 5.8 16.8

SD 0.28 0.37 0.67

CV / 6.42% 4.00%

2-3 Evaluation Results

The intermediate measurement accuracy of this blood glucose monitoring system meets our company’s acceptance

criteria.

2-1. Test basis: EN ISO 15197:2015, 6.2.4. Acceptance criteria: At blood glucose concentrations < 5.55 mmol/L

(< 100 mg/dL), results shall be within ±15 mg/dL (±0.83 mmol/L) of the reference measurement procedure; at

concentrations ≥ 5.55 mmol/L (≥ 100 mg/dL), results shall be within ±15% of the reference measurement procedure.

Information for Healthcare Professionals:

-Clinically, it is not recommended to measure blood glucose in acutely ill patients

using a blood glucose meter.

-Lipemic samples: It is not recommended to test samples from severely lipemic

patients with the Novacheck® LM-602 system.

-Healthcare professionals who measure blood glucose in a large number of

patients should always wear gloves and follow the infection control regulations and

procedures approved by their institution.

-When using the Novacheck® LM-602 blood glucose meter, always follow standard

procedures for handling and transporting items potentially contaminated with

human material.

-Only one drop of blood is required to measure blood glucose. Capillary and

venous whole blood samples can be used.

-Avoid air bubbles when using a pipette.

-Samples stored in a refrigerator should be brought to room temperature before

testing.

-Inaccurate results may be observed in patients or individuals in shock.

-Individuals experiencing hyperglycemic hyperosmolar state (HHS), with or without

ketoacidosis, may obtain inaccurate results. Clinically ill individuals should not

perform tests with a blood glucose meter.

-If whole blood samples are collected in tubes containing heparin, testing should be

performed promptly. Do not use other anticoagulants or preservatives unless their

compatibility has been verified.

References

Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Work-

ers From Occupationally Acquired Infections; Approved Guideline—Third Edition.

CLSI document M29-A3. Wayne, PA: CLSI; 2005. ISBN: 1-56238-567-4.

Burtis CA, Ashwood ER, eds. Tietz Fundamentals of Clinical Chemistry. 5th ed.

Philadelphia: W.B. Saunders; 2001.

Atkin SH, Dasmahapatra A, Jaker MA, et al. Fingerstick glucose determination in

shock. Annals of Internal Medicine. 1991;114(12):1020–1024.

doi:10.7326/0003-4819-114-12-1020.

Clinical and Laboratory Standards Institute (CLSI). Interference Testing in Clinical

Chemistry; Approved Guideline—Second Edition. CLSI document EP7-A2. Wayne,

PA: CLSI; 2005.

4°C

32°C

Başpınar (Organize) OSB Mahallesi

OSB 2. Bölge 83228 Nolu Cadde No:17

Şehitkamil / Gaziantep / TÜRKİYE

Tel: +90 342 502 27 27 Fax: +90 342 503 01 30

Postal Code: 27600

DOC.ID:TD-18A/04

Rev. Tarih: 06.01.2026