BTG SMARTEST GLUCOSE TEST SYSTEM
Device Facts
| Record ID | K032029 |
|---|---|
| Device Name | BTG SMARTEST GLUCOSE TEST SYSTEM |
| Applicant | Bt Medical |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Dec 18, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The BTg Smartest Glucose test system is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Device Story
System measures glucose in whole blood via electrochemical test strips; chemical reaction between glucose and strip reagents generates electrical current. Meter detects current; calculates glucose concentration; displays result. Used by healthcare professionals or patients at home for diabetes management. Provides quantitative blood glucose levels to assist in monitoring therapy effectiveness.
Clinical Evidence
No clinical data provided; substantial equivalence based on bench testing of analytical performance and comparison of technological characteristics.
Technological Characteristics
Electrochemical biosensor using glucose oxidase enzyme. Measuring range 20-600 mg/dL. Meter dimensions 115 x 44 x 21 mm. Standards referenced: NCCLS, EN 1441 (risk analysis), EN 60601-1-2 (EMC).
Indications for Use
Indicated for quantitative glucose measurement in whole blood for healthcare professionals and patients with diabetes mellitus to monitor diabetes control programs. Contraindicated for neonates and not for diagnosis or screening of diabetes.
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
- Bayer Elite with the Ascensia Elite test strips (K991242)
Related Devices
- K111371 — ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM · ACON Laboratories, Inc. · Oct 6, 2011
- K092104 — ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM · Arkray Factory USA, Inc. · Nov 24, 2009
- K041107 — TAIDOC CHECK · Taidoc Technology Corporation · Jun 18, 2004
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number: k032029
B. Analyte: whole blood glucose
C. Type of Test: Quantitative, utilizing Glucose Oxidase technology.
D. Applicant: BT Medical
E. Proprietary and Established Names: BTg Smartest Glucose Test System
F. Regulatory Information:
1. Regulation section:
21 CFR 862.1345 Glucose Test System
21 CFR 862.1660 Quality Control Material
2. Classification:
Class II
3. Product Code:
NBW, System, Test, Blood Glucose, Over The Counter
CGA, Glucose Oxidase, Glucose
JJX, Single (Specified) Analyte Controls
4. Panel:
Chemistry (75)
G. Intended Use:
1. Indication(s) for use:
The BTg Smartest Glucose test system is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
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2. Special condition for use statement(s):
Provides plasma equivalent results.
Do Not Use for neonatal specimens.
3. Special instrument Requirements:
N/A
H. Device Description:
The BT Medical BTg Smartest Blood Glucose Monitoring System consists of the Glucose Meter, Lancing Device, 10 Lancets, User Manual, Carrying Case, Glucose Strips, 1 vial of Normal Control, and 1 vial of High Control.
I. Substantial Equivalence Information:
1. Predicate device name(s):
Bayer Elite with the Ascensia Elite test strips.
2. Predicate K number(s):
K991242
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Predicate Device | Proposed Device |
| | Bayer ELITE (K991241) | BTG (K032029) |
| Similarities | 1. Monitors glucose using whole blood.
2. Directly displays results without requiring calculation.
3. Test Principle includes measuring a current produced by a chemical reaction.
4. Test Principle: Uses glucose oxidase reaction.
5. Measuring Range: 20 to 600 mg/dL. | 1. Monitors glucose using whole blood.
2. Directly displays results without requiring calculation.
3. Test Principle includes measuring a current produced by a chemical reaction.
4. Test Principle: Uses glucose oxidase reaction.
5. Measuring Range: 20 to 600 mg/dL. |
| | ELITE | BTG |
| Differences | 1. Size: Meter is 97.8 x 56 x 14.5 mm.
2. Measuring time: 30 seconds. | 1. Size: Meter is 115 x 44 x 21, which is longer and slimmer, but thicker than the ELITE.
2. Measuring time: 15 seconds. |
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J. Standard/Guidance Document Referenced (if applicable):
NCCLS Standards, EN 1441(1997) Medical Devices – Risk Analysis, FDA guidance document; Guidance for the content of Premarket Submissions for Software contained in Medical Devices, Clarke Error Grid Analysis, EN60601-1-2(2002) Medical Electrical Equipment
K. Test Principle:
Electrochemical biosensor technology using glucose oxidase is used. The strip uses the enzyme glucose oxidase to produce a current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision describes the variation between readings. A test system that gives equivalent values every time is said to be precise.
A laboratory study was conducted using venous heparinized blood samples. These were adjusted to a broad range of glucose values by adding glucose to the blood. The results from a single precision run are shown in the table below.
| Number of tests | 20 | 20 | 20 | 20 | 20 |
| --- | --- | --- | --- | --- | --- |
| Glucose value in mg/dL | 47.7 | 91.3 | 165.8 | 199.4 | 412.7 |
| SD | 3.69 | 7.19 | 9.40 | 11.02 | 25.03 |
| % CV | 7.74 | 7.87 | 5.67 | 5.53 | 6.06 |
This means that repeated results should vary by less than 8%
b. Linearity/assay reportable range:
Linearity testing was performed to confirm that the device is capable of accurately reporting results in the claimed dynamic measuring range. 60 samples were prepared by allowing a sample to glycolyze to 17 mg/dL then spiking an aliquot to a concentration of 612 mg/dL and making 11 dilutions of the high and low samples. The samples were analyzed 5 times for glucose on both the predicate device Bayer ELITE and on the BT Medical BTg Smartest. The regression results are in the table below.
| | BTg Glucose vs. Bayer ELITE Glucose |
| --- | --- |
| Range of Samples | 17 to 612 mg/dL |
| n | 60 |
| Slope | 1.0241 |
| y-intercept (mg/dL) | -4.8 |
| Correlation Coefficient (r) | 0.9992 |
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This system can measure glucose results from $20 - 600\mathrm{mg / dL}$
c. Traceability (controls, calibrators, or method): None stated
d. Detection limit: N/A
e. Analytical specificity:
Interference testing was conducted to determine the effect of select endogenous and exogenous substances. A series of test samples, systematically varying in the concentration of the interferents, was prepared by making quantitative, volumetric mixtures. The substances and concentrations of the interferents are recommended at NCCLS EP7-P.
# Conclusions:
The BTG Smartest Glucose Test Strip showed no significant interference due to the substances tested, with the exception of ascorbic acid (Vitamin C), and dopamine.
- Vitamin C of greater than $0.75 \mathrm{mg} / \mathrm{dL}$ in blood decreased the glucose result.
- Dopamine greater than $3.25\mathrm{mg / dL}$ in blood increased the glucose result.
f. Assay cut-of: N/A
# 2. Comparison studies:
a. Method comparison with predicate device:
One hundred fifty-four (154) subjects at three sites, including three point-of-care (POC) sites (physician offices) tested their own glucose and were tested by a professional using the BTg Smartest Glucose Test System and the Bayer ELITE (predicate). Fingerstick capillary blood was the sample. The BTg Smartest was calibrated using 10 levels of whole blood glucose and fitted to a straight line. The correlation data is listed in the table that follows:
Accuracy Statistics Summary
| | BTG Professional vs. Bayer Elite | BTG Consumer vs. Bayer Elite |
| --- | --- | --- |
| Number of Patients (n) | 154 | 154 |
| Number of sites | 3 | 3 |
| Slope | 0.9565 | 0.9601 |
| Upper 95% CI for slope | 1.000 | 1.0048 |
| Lower 95% CI for slope | 0.9123 | 0.9154 |
| | | |
| Intercept | 7.375 | 5.882 |
| Upper 95% CI for intercept | 0.960 | -0.710 |
| Lower 95% CI for intercept | 13.79 | 12.474 |
| | | |
| Standard Error of the Estimate (mg/dL) | 17.900 | 18.395 |
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| Correlation Coefficient (r) | 0.9620 | 0.9603 |
| --- | --- | --- |
| Range of Glucose Values (mg/dL) | 58 – 447 | 43 – 462 |
| Mean of Elite method (mg/dL) | 132 | 132 |
| Mean of BTG method (mg/dL) | 134 | 133 |
| | | |
| Bias (measurement error) at 126 mg/dL | 1.89 | 0.85 |
| Average bias (mg/dL) | 1.63 | 0.61 |
b. Matrix comparison: N/A
3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when $a$ and $b$ are not applicable):
4. Clinical cut-off: N/A
5. Expected values/Reference range:
70-110 mg/dL- adult fasting glucose reference range according to Norbert Tietz's Fundamentals of Clinical Chemistry
126 mg/dL – the fasting glucose level that is diagnostic for Diabetes according to the clinical practice guidelines of the American Diabetes Association
# M. Conclusion:
Based upon the information provided in this submission, this device is Substantially Equivalent to 21 CFR 862.1345, 75 NBW, System, Test, Blood Glucose, Over the Counter and 75 CGA Glucose Oxidase, Glucose.
