510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

DECISION SUMMARY

DEVICE AND INSTRUMENT TEMPLATE 

A.     510(k) Number:  k0411039

B.     Purpose for Submission:

Clearance of whole blood glucose test system

C.     Analyte: Whole Blood glucose

D.    Type of Test: Electrochemical biosensor

E.     Applicant:

HERS MEDICAL CO., LTD

F.      Proprietary and Established Names:

HERS MEDICAL Check Blood Glucose Test System

G.    Regulatory Information:

1.      Regulation section:

21 CFR § 862.1345, Glucose test system

21 CFR § 862.1660, Quality control material (assayed and unassayed)

2.      Classification:

Class II, Class I

3.      Product Code:

NBW, Blood glucose test system, over the counter

CGA, Glucose test system

JJX, Single (specified) analyte controls (assayed and unassayed)

4.      Panel:

Clinical Chemistry (75)

H.    Intended Use:

1.      Intended use(s):

 

HERS MEDICAL Check Blood Glucose test system is intended for use in the quantitative measurement of glucose in whole blood taken from the finger.  It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

2.      Indication(s) for use:

See Intended use above

3.      Special condition for use statement(s):

For over the counter and professional use

4.      Special instrument Requirements:

HERS MEDICAL Check Glucose meter

I.       Device Description:

HERS MEDICAL Check Blood Glucose test system consists of a glucose test meter, test strips, two levels of control solution, and a commercially available (510(k) cleared) lancing device.

J.      Substantial Equivalence Information: 

1.      Predicate device name(s):

Bayer Glucometer Elite Diabetes Care System

2.      Predicate K number(s):

k020209

3.      Comparison with predicate:

NCCLS Guideline EP5-A - Evaluation of Precision Performance of Clinical Chemistry Devices

NCCLS Guideline EP6-P2 - Evaluation of the Linearity of Quantitative Analytical Methods

NCCLS Guideline EP7-A - Interference Testing in Clinical Chemistry

NCCLS Guideline EP9-A - Method Comparison and Bias Estimation Using Patient Samples

prEN 13640

ISO 15197

IEC 60601-1 (1998), IEC 61010-1 (1990), EN 60601-1 (2001), EN 61010-1 (2001)

L.     Test Principle

Once a whole blood sample is applied to the sample chamber of the test strip, glucose measurement commences. Glucose measurement is based on electrical potential caused by the reaction of glucose with the reagents contained on the strip’s electrodes. The glucose in the sample is oxidized by the enzyme glucose oxidase, producing gluconolactone. The current resulting from this enzymatic reaction is measured and converted to glucose concentration by the meter. The magnitude of the current is proportional to the concentration of glucose in the sample.

M.  Performance Characteristics (if/when applicable):

1.      Analytical performance:

a.      Precision/Reproducibility:

Spiked recovery was evaluated by preparing spiked glucose samples across the measuring range and comparing them to a laboratory measurement of the same samples. Whole blood was depleted of glucose by allowing it to sit at room temperature for 24 hours. The blood was then spiked to 11 targeted glucose concentrations (20, 40, 60, 80, 120, 160, 200, 240, 320, 440, and 560 mg/dL). The spiked samples were measured in duplicate and the resultant regression equation when the observed results were plotted against results from a laboratory reference method was y = 1.0705x + 16.215 (R² = 0.997).  

The reportable range of the assay is 20 – 600 mg/dL.

c.       Traceability (controls, calibrators, or method):

Two levels of control material (normal and high) are provided for use with the test system. The target values are 125 mg/dL and 300 mg/dL and are prepared gravimetrically in an aqueous matrix.  Expected values are verified for each manufactured lot. The open, closed, and transport stability were tested.

d.      Detection limit:

20 to 600 mg/dL

e.       Analytical specificity:

The sponsor tested the effects of hematocrit (20-60%), temperature, humidity, resistance to drop and vibration, and high altitude (3275 meters) on the meter’s performance. The sponsor claims that there is no effect of any of these factors on glucose results (defined as within +/- 15 mg/dL difference in samples below 75 mg/dL and within +/- 20% in samples above 75 mg/dL).  

The sponsor tested 6 exogenous and 2 endogenous substances for interference with their meter. No interference (defined as +/- 10% of control) was seen to the following concentrations: 

Acetaminophen – up to 5 mg/dL

Ascorbic acid – up to 1.25 mg/dL

Dopamine – up to 2 mg/dL

L-Dopa – up to 3 mg/dL

Methyl Dopa – up to >0.5 mg/dL

Tolbutamide – up to 200 mg/dL

Uric acid – up to 10 mg/dL

Triglyceride – up to 2000 mg/dL 

The insert states that no interferences are seen at normal physiological levels of these potential interferents as the levels at which interference is seen are above the normal observed physiological concentrations of these substances.

f.        Assay cut-off:

Not applicable

2.      Comparison studies:

a.      Method comparison with predicate device:

Clinical technicians obtained blood glucose concentrations from 120 patients at 3 sites using the device and the results were compared to results from venous blood samples from the same patients that were analyzed on a clinical laboratory analyzer. The technician vs. laboratory regression statistics are summarized below for the three sites. 

Site 1:  Technician = 1.089(Lab) – 9.8276; r = 0.9869

Site 2:  Technician = 1.0626(Lab) – 6.901; r = 0.9870

Site 3:  Technician = 0.9952(Lab) + 1.8574; r = 0.9866

b.      Matrix comparison:

Not applicable

3.   Clinical studies:

a.   Clinical sensitivity:

Not applicable

b.   Clinical specificity:

Not applicable

c.   Other clinical supportive data (when a and b are not applicable):

Clinical technicians obtained blood glucose concentrations from 120 patients at 3 sites using the device and the results were compared to results obtained when the same patients tested their own blood glucose levels. The technician vs. user regression statistics are summarized below for the three sites. 

Site 1:  User = 0.8647(Technician) + 15.477; r = 0.9785

Site 2:  User = 0.9812(Technician) + 3.7056; r = 0.9863

Site 3:  User = 0.9937(Technician) + 0.8674; r = 0.9900 

Patients (n = 120)  obtained blood glucose concentrations at 3 sites using the device and the results were compared to results from venous blood samples from the same patients that were analyzed on a clinical laboratory analyzer. The user vs. laboratory regression statistics are summarized below for the three sites. 

Site 1:  User = 0.9516(Lab) + 5.5478; r = 0.9882

Site 2:  User = 1.0485(Lab) – 3.8361; r = 0.9844

Site 3:  User = 0.9905(Lab) + 2.4982; r = 0.9800 

One hundred users (23 Europeans and 77 Taiwanese) were given the instructions for use and asked to fill out a questionnaire relating to the readability of the Instructions for Use. The insert evaluation showed acceptable readability.

4.   Clinical cut-off:

Not applicable

5.   Expected values/Reference range:

The package insert indicates the following reference range for fasting blood glucose: 70 – 110 mg/dL. The labeling advises that users should consult their physician to determine their own appropriate range.

N.    Instrument Name:

HERS MEDICAL Check Blood Glucose meter

O.    System Descriptions:

1.    Modes of Operation:

Manual – insertion of test strip and sample application start the test

2.         Software: software language – Assembly 6502

Requires RS232 interface, setting buttons, and test strip port

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ___3___ or No ________

3.         Sample Identification:

Not applicable. Sample is fresh capillary blood from a fingerstick. The meter stores up to 180 test results.

4.         Specimen Sampling and Handling:

Manual – sample (fresh whole blood) acquired by fingerstick

5.         Assay Types:

Chemistry

6.         Reaction Types:

Electrochemical

7.         Calibration:

Calibration information is contained on a coding strip that is contained in each test strip vial. The user codes the meter with the lot code strip and the meter stores the calibration information for strips with that code.

8.         Quality Control:

Two levels of quality control material are provided with the system.

P.      Other Supportive Instrument Performance Characteristics Data Not Covered In The “L.  Performance Characteristics” Section Of The SE Determination Decision Summary:

Q.    Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.