AG-608N BLOOD GLUCOSE MONITORING SYSTEM
Device Facts
| Record ID | K110017 |
|---|---|
| Device Name | AG-608N BLOOD GLUCOSE MONITORING SYSTEM |
| Applicant | Andon Medical Co., Ltd. |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Jan 18, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The AG-608N single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AG-608N single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-608N single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The AGS-1000N single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles. The AG-608N MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is only used with single-use lancing devices. The AG-608N MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly). The AGS-1000N MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
Device Story
System uses electrochemical biosensor technology; glucose oxidase enzyme reacts with capillary whole blood glucose to generate electrical current; meter measures current to calculate glucose concentration. Input: 0.7μL capillary blood sample on AGS-1000N test strip. Output: quantitative blood glucose level displayed on meter. Used in home (Single version) or professional healthcare settings (MULTI version). MULTI version validated for multiple-patient use with CaviWipes disinfection. Data transmission via USB to PC application. Results aid healthcare providers in monitoring diabetes control effectiveness. Benefits: provides rapid, point-of-care glucose monitoring for diabetes management.
Clinical Evidence
Clinical user performance study conducted with 100 lay-users. Glucose concentrations ranged 57-305 mg/dL. Results met ISO 15197 accuracy criteria: 95% of results within ±15 mg/dL for <75 mg/dL and within ±20% for ≥75 mg/dL across all test sites (finger, palm, forearm, upper arm, calf, thigh). Bench testing included precision (CV 2.07-3.48%), linearity (r²=0.9983), interference studies, altitude (up to 10,744 ft), and hematocrit (20-60%).
Technological Characteristics
Electrochemical biosensor; glucose oxidase enzyme; auto-coding; measuring range 20-600 mg/dL; reaction time 5 seconds; sample volume 0.7μL. Connectivity: USB for data transmission. Operating conditions: 50-104°F, <80% RH. Storage: 39-86°F, <80% RH. Complies with ISO 15197, ISO 14971, EN 60601-1-1, EN 60601-1-2, EN 61326-1, and IEC/EN 61010-2-101.
Indications for Use
Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertips, palm, forearm, upper arm, calf, and thigh. Intended for diabetes control monitoring in professional settings (MULTI version) or home self-testing (Single version). Contraindicated for neonatal use, diabetes diagnosis/screening, and critically ill patients. Not for use on patients with dehydration, hypotension, shock, or hyperglycemic-hyperosmolar state.
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
- AG-608 Blood Glucose Monitoring System (k093262)
Related Devices
- K111456 — MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM · Tianjin Empecs Medical Device Co., Ltd. · Feb 28, 2012
- K132072 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM · Nipro Diagnostics, Inc. · Aug 15, 2013
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k110017
B. Purpose for Submission:
New device
C. Measurand:
Capillary whole blood glucose
D. Type of Test:
Quantitative, electrochemical biosensor, glucose oxidase
E. Applicant:
Andon Medical Co. Ltd.
F. Proprietary and Established Names:
AG-608 N Single Blood Glucose Monitoring System
AG-608 N MULTI Blood Glucose Monitoring 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 (assay)
Class I, reserved
3. Product code:
NBW, Blood Glucose Test System, Over-the-Counter
CGA, Glucose Oxidase
JJX, Single (Specified) Analyte Controls
4. Panel:
Clinical Chemistry (75)
H. Intended Use:
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1. Intended use(s):
See indication for use below.
2. Indication(s) for use:
AG-608N MULTI Blood Glucose Monitoring System
The AG-608N MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is only used with single use lancing devices.
The AG-608N MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly).
The AGS-1000N MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
AG-608N Single Blood Glucose Monitoring System
The AG-608N Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-608N single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-608N single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady – state times (when glucose is not changing rapidly).
The AGS-1000N single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.
The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test
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strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles.
3. Special conditions for use statement(s):
- For in vitro diagnostic use only
- Over-the-Counter and Prescription Use
- Not intended for use on neonates
- Not for the diagnosis of or screening for diabetes mellitus
- Not for use on patients who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
- Critically ill patients should not be tested with a blood glucose meter.
- Allows testing on the fingertip, palm, forearm, upper arm, calf, or thigh
- Alternative site testing (AST) can be used only during steady-state blood glucose conditions. AST should ONLY be used in the following intervals:
- In a pre-meal or fasting state (more than 2 hours since the last meal)
- Two hours or more after taking insulin
- Two hours or more after exercise
- AST results should not be used to calibrate a continuous glucose monitor (CGM) or in insulin dose calculations
4. Special instrument requirements:
AG-608 N Single Blood Glucose meter
AG-608 N Multi Blood Glucose meter
I. Device Description:
The AG-608N Single and AG-608 N MULTI Blood Glucose Monitoring Systems contain a blood glucose meter (AG-608N Single or AG-608 N MULTI, respectively) AGS-1000N Single/AGS-1000N MULTI blood glucose test strips. These are no code meters. The Level II control solution, Owner's booklet and carrying case are provided in the kit. Level I and Level III control solutions, lancing device, and sterile lancets are optional/sold separately.
The differences between the single-patient use (AG-608N Single) and the multiple patient use systems (AG-608N MULTI) are the labeling, which includes the names of the system components, disinfection instructions for using the device on single-patients versus in multiple patient use settings, and the lancing devices that can be used with the different systems.
Control solutions (Level I, Level II and Level III) are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. The products are intended for use to verify the performance of the AG-608N Single and AG-608 N MULTI Blood Glucose Monitoring Systems.
J. Substantial Equivalence Information:
1. Predicate device name(s):
The AG-608 Blood Glucose Monitoring System
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The AG-610 Blood Glucose Monitoring System
2. Predicate k number(s):
k093262
3. Comparison with predicate:
| Item | AG-608 N Single Blood Glucose Monitoring System
AG-608 N MULTI Blood Glucose Monitoring System | AG-608 Blood Glucose Monitoring System
AG-610 Blood Glucose Monitoring System
(k093262) |
| --- | --- | --- |
| Blood Glucose Test Principle: Similarities and Differences | | |
| Intended use | For the quantitative measurement of glucose, as an aid to monitor the effectiveness of diabetes control. | Same |
| Enzyme | Glucose Oxidase | Same |
| Test sample | Fresh whole blood from fingertip, palm, forearm, upper-arm, calf and thigh | Fresh whole blood from fingertip |
| Test strips | AGS-1000 N | AGS-1000 |
| Measuring range | 20 – 600 mg/dL | Same |
| Hematocrit | 20%-60% | 30% – 55% |
| Altitude | 10, 744ft | 11,975 feet (3650 meters) |
| PC connection/Transmission function | USB | N/A |
| Reaction time | 5 seconds | Same |
| Coding function | Auto coding | Code Bottle |
| Operation condition | 50 to 104°F (10 to 40°C) with relative humidity < 80% | Same |
| Memory | 500 measurement results with time and date | 350 measurement results with time and date |
K. Standard/Guidance Document Referenced (if applicable):
- ISO 14971:2007. Medical devices-Application of risk management to medical devices.
- ISO 15197. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
- EN 60601-1-1. Medical electrical equipment, Part 1-1. General requirements for safety. Safety requirements for medical electrical systems.
- EN 60601-1-2:2001 (A1:2006). Medical electrical equipment, Part 1-2. General
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requirements for basic safety and essential performance. Electromagnetic Compatibility.
- EN 61326-1:2006. Electrical equipment for measurement, control, and laboratory use. EMC Requirements. General requirements.
- IEC/EN 61010-2-101:2002. Safety requirements for electrical equipment for measurement, control, and laboratory use, Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment.
- ISO15197:2003 ISO 14971:2000 - Medical devices – Application of risk management
L. Test Principle:
The test is based on electrochemical biosensor technology and the principle of capillary action. The electrical current generated by the reaction of glucose with the reagent of the strip is measured by the meter and is displayed as the corresponding blood glucose level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
The sponsor performed precision studies in accordance with the ISO 15197 and CLSI EP-5A. Venous whole blood adjusted to 5 glucose levels with hematocrit ~40% was used for within-day precision studies. Each concentration was tested 10 times using three test strip lots, for a total of 100 tests per blood glucose level. Results are summarized below:
Within Day precision:
| Sample Level (mg/dL) | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- |
| 30 -50 | 43.9 | 1.4 | 3.17 |
| 51 -110 | 95.8 | 2.7 | 2.86 |
| 111 -150 | 131.8 | 4.4 | 3.33 |
| 151 - 250 | 207.7 | 6.8 | 3.26 |
| 251 - 400 | 317.0 | 10.5 | 3.31 |
In addition to the study above, the sponsor also evaluated day-to-day precision using control solutions with three concentration levels of glucose (45 mg/dL, 120 mg/dL and 320 mg/dL). Day-to-day precision was evaluated over a 10 day period with, three lots of test strips, and 10 meters. Results are summarized below:
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Between Day precision:
| Control Solution Level | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- |
| 45 mg/dL | 43.9 | 1.5 | 3.48 |
| 120 mg/dL | 126.6 | 3.6 | 2.83 |
| 320 mg/dL | 310.1 | 6.4 | 2.07 |
b. Linearity/assay reportable range:
The sponsor performed linearity studies using whole blood samples with 11 different glucose concentration levels covering the full measuring range (20-600 mg/dL). Measurements were taken 5 times for each level and the values of the AG-608N meter were compared to those obtained from the YSI-2300. Linear regression analysis is summarized below:
$$
y = 0.9959x + 2.6769, r^2 = 0.9983
$$
The measuring range of the AG-608 N Single/Multi Blood Glucose Monitoring Systems is 20 - 600 mg/dL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The sponsor claims that the system accuracy of the AG-608 N Single/Multi Blood Glucose Monitoring Systems is calibrated to a laboratory analyzer, YSI 2300. See comparison studies in 2a below.
One levels of control material, Level II (96 to 144 mg/dL) is available for use with this test system.
Value assignment:
The control solutions (Level I 30-50 mg/dL; Level II 96-144 mg/dL and Level III 280-420 mg/dL) are prepared in an aqueous matrix. Value assignment was established using 5 glucose meters and 100 test strips from one test strip lot. The control range for each control solution is listed on the test strip vial. The final control ranges, printed on the vials, are within ±10 mg/dL for Level I and ±10% of the mean value for Level I and II. The expected results may change with each new lot. However, in the package insert, the user is directed to compare their control result with the range printed on the test strip vial.
Stability:
Control solution and test strip stability was assessed with accelerated studies and on-going real-time studies. Testing supports the claimed shelf life of 24 month shelf-life when stored at 39 to 86°F (2-30°C) with relative humidity of
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<80% and a 90 day stability after opening when stored at 39 to 86°F with relative humidity of <80 %.
d. Detection limit:
The measuring range of the devices is 20-600 mg/dL. This range was validated via the linearity study (see section M.1.b.).
e. Analytical specificity:
The sponsor performed interference studies with spiked venous blood samples at three glucose concentrations (~80, 120 and 350 mg/dL) that were prepared and divided into a test (dosed) pool and a control pool. The potential interferants (2 levels) were added to the sample and each sample was tested 5 times. The table below lists all substances tested at concentrations with insignificant (<10%) interference:
| Substance | Concentration with <10% interference (mg/dL) |
| --- | --- |
| Acetaminophen | 5.0 |
| Ascorbic acid | 2.0 |
| Bilirubin | 15 mg/dL |
| Ibuprofen | 50 mg/dL |
| Dopamine | 0.03 mg/dL |
| L-dopa | 0.45 mg/dL |
| Methyldopa | 0.75 mg/dL |
| Salycilate | 60 mg/dL |
| Tolbutamide | 24 mg/dL |
| Triglycerides | 2000 mg/dL |
| Uric acid | 10 mg/dL |
| Maltose | 350 mg/dL |
| Xylose | 100 mg/dL |
| Galactose | 15.1 mg/dL |
| Lactose | 100 mg/dL |
| Creatinine | 17 mg/dL |
| Sodium | 639 mg/dL (MW 58.5) |
| Hemoglobin | 250 mg/dL |
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison:
System Accuracy:
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The sponsor conducted an accuracy study to demonstrate that the accuracy of the candidate device is equivalent to the reference method, YSI 2300. Testing was performed with 2 trained operators and a total of 100 capillary samples. The total range of samples tested was $25 - 537\mathrm{mg / dL}$ . Samples $< 40\mathrm{mg / dL}$ and $>400\mathrm{mg / dL}$ were glycolyzed or spiked. Distribution of blood glucose concentration across the samples tested was in accordance with the ISO15197. The studies met the ISO 15197 accuracy criteria where ninety-five percent $(95\%)$ of the individual glucose results shall fall within $\pm 15\mathrm{mg / dL}$ of the results at glucose concentrations $< 75\mathrm{mg / dL}$ and within $\pm 20\%$ at glucose concentrations $\geq 75\mathrm{mg / dL}$ . Linear regression results are presented below:
Professionals vs YSI
| | Finger | Palm | Forearm | Upper arm | Calf | Thigh |
| --- | --- | --- | --- | --- | --- | --- |
| Slope | 0.9768 | 0.9788 | 0.9564 | 0.9703 | 0.9553 | 0.9626 |
| Y-Intercept | 5.7213 | 4.0069 | 7.1188 | 4.7946 | 6.7018 | 6.4056 |
| R | 0.9795 | 0.9818 | 0.9817 | 0.9801 | 0.9806 | 0.9839 |
The study results met the ISO 15197 accuracy criteria where ninety-five percent (95%) of the individual glucose results fell within $\pm 15\mathrm{mg / dL}$ of the YSI results at glucose concentrations $< 75\mathrm{mg / dL}$ and within $\pm 20\%$ at glucose concentrations $\geq 75\mathrm{mg / dL}$ .
For glucose concentrations $< 75\mathrm{mg / dL}$
| | | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- | --- | --- |
| Finger | Meter 1 | 13/19(68.4%) | 18/19(94.7%) | 19/19(100.0%) |
| | Meter 2 | 11/19(57.9%) | 17/19(89.5%) | 19/19(100.0%) |
| Palm | Meter 1 | 13/19(68.4%) | 17/19(89.5%) | 19/19(100.0%) |
| | Meter 2 | 14/19(73.7%) | 18/19(94.7%) | 19/19(100.0%) |
| Forearm | Meter 1 | 14/19(73.7%) | 18/19(94.7%) | 19/19(100.0%) |
| | Meter 2 | 13/19(68.4%) | 18/19(94.7%) | 19/19(100.0%) |
| Upper arm | Meter 1 | 11/19(57.9%) | 17/19(89.5%) | 19/19(100.0%) |
| | Meter 2 | 15/19(78.9%) | 18/19(94.7%) | 19/19(100.0%) |
| Calf | Meter 1 | 13/19(68.4%) | 18/19(94.7%) | 19/19(100.0%) |
| | Meter 2 | 14/19(73.7%) | 17/19(89.5%) | 19/19(100.0%) |
| Thigh | Meter 1 | 13/19(68.4%) | 17/19(89.5%) | 19/19(100.0%) |
| | Meter 2 | 12/19(63.2%) | 18/19(94.7%) | 19/19(100.0%) |
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For samples $\geq 75\mathrm{mg / dL}$
| | | Within±5% | Within±10% | Within±15% | Within±20% |
| --- | --- | --- | --- | --- | --- |
| Finger | Meter 1 | 43/81(53.1%) | 60/81(74.1%) | 80/81(95.1%) | 80/81(98.8%) |
| | Meter 2 | 40/81(49.4%) | 64/81(79.0%) | 79/81(97.5%) | 81/81(100.0%) |
| Palm | Meter 1 | 36/81(44.4%) | 60/81(74.1%) | 77/81(95.1%) | 81/81(100.0%) |
| | Meter 2 | 39/81(48.1%) | 64/81(79.0%) | 76/81(93.8%) | 81/81(100.0%) |
| Forear m | Meter 1 | 43/81(53.1%) | 62/81(76.5%) | 78/81(96.3%) | 81/81(100.0%) |
| | Meter 2 | 39/81(48.1%) | 63/81(77.8%) | 77/81(95.1%) | 81/81(100.0%) |
| Upper arm | Meter 1 | 44/81(54.3%) | 66/81(81.5%) | 77/81(95.1%) | 81/81(100.0%) |
| | Meter 2 | 42/81(51.9%) | 62/81(76.5%) | 77/81(95.1%) | 80/81(98.8%) |
| Calf | Meter 1 | 40/81(49.4%) | 63/81(77.8%) | 77/81(95.1%) | 79/81(97.5%) |
| | Meter 2 | 41/81(50.6%) | 62/81(76.5%) | 76/81(93.8%) | 80/81(98.8%) |
| Thigh | Meter 1 | 41/81(50.6%) | 66/81(81.5%) | 80/81(98.8%) | 81/81(100.0%) |
| | Meter 2 | 41/81(50.6%) | 64/81(79.0%) | 79/81(97.5%) | 80/81(98.8% |
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): User Performance Study: The sponsor performed a consumer study to test the effects of 100 lay-users on the performance of their candidate device. The study subjects ranged in age, education, and were about equally divided between males and females. The blood samples with glucose concentrations ranging from 57 to $305\mathrm{mg / dL}$ were tested. The studies met the ISO 15197 accuracy criteria where ninety-five percent $(95\%)$ of the individual glucose results shall fall within $\pm 15\mathrm{mg / dL}$ of the results at glucose concentrations $< 75\mathrm{mg / dL}$ and within $\pm 20\%$ at glucose concentrations $\geq 75\mathrm{mg / dL}$ . Results are summarized below:
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Lay user vs YSI
| | Finger | Palm | Forearm | Upper arm | Calf | Thigh |
| --- | --- | --- | --- | --- | --- | --- |
| Slope | 0.9957 | 1.0224 | 1.0251 | 1.0135 | 1.0254 | 1.0091 |
| Y-Intercept | -0.7454 | -3.3596 | -3.8009 | -2.5447 | -0.3568 | -0.0669 |
| R | 0.9785 | 0.9759 | 0.9774 | 0.973 | 0.9752 | 0.9733 |
Lay users using AG-608 N vs. YSI
For samples < 75 mg/dL
| | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- | --- |
| Finger | 9/16(56.3%) | 16/16(100.0%) | 16/16(100.0%) |
| Palm | 9/14(64.3%) | 13/14(92.9%) | 14/14(100.0%) |
| Forearm | 10/16(62.5%) | 13/16(81.3%) | 16/16(100.0%) |
| Upper arm | 5/16(31.3%) | 14/16(87.5%) | 16/16(100.0%) |
| Calf | 11/16(68.8%) | 14/16(87.5%) | 16/16(100.0%) |
| Thigh | 12/16(75.0%) | 15/16(93.8%) | 16/16(100.0%)) |
For samples ≥ 75 mg/dL
| | Within±5% | Within±10% | Within±15% | Within±20% |
| --- | --- | --- | --- | --- |
| Finger | 45/84(53.6%) | 68/84(81.0%) | 83/84(98.8%) | 84/84(100.0%) |
| Palm | 43/86(50.0%) | 69/86(80.2%) | 84/86(97.7%) | 86/86(100.0%) |
| Forearm | 47/84(56.0%) | 66/84(78.6%) | 83/84(98.8%) | 84/84(100.0%) |
| Upper arm | 50/84(59.5%) | 67/84(79.8%) | 81/84(96.4%) | 84/84(100.0%) |
| Calf | 40/84(47.6%) | 65/84(77.4%) | 83/84(98.8%) | 84/84(100.0%) |
| Thigh | 39/84(46.4%) | 69/84(82.1%) | 82/84(97.6%) | 84/84(100.0%) |
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Expected blood glucose levels for people without diabetes (referenced from the American Diabetes Association, Clinical Practice Recommendations (2010). Diabetes Care, Vol. 33, Supplement 1, p. S1-S100.
Time
Fasting and
Range (mg/dL)
Less than 100mg/dL
Range (mmol/L)
5.6mmol/L
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before meals
Two hours after meals
Less than 140 mg/dL
7.8 mmol/dL
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N. Instrument Name:
AG-608 N Single Blood Glucose Meter
AG-608 N MULTI Blood Glucose Meter
O. Systems Descriptions:
1. Modes of Operation:
Each test strip is single use and must be replaced with a new strip for additional readings.
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?:
Yes ☐ X (cleared in k102678) or No ☐
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?:
Yes ☐ or No ☐ X
2. Software:
FDA reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
3. Specimen Identification:
There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.
4. Specimen Sampling and Handling:
This device is intended to be used with capillary whole blood from the finger and other alternative sites (palm, forearm, upper-arm, calf and thigh). Since the whole blood sample is applied directly to the test strip, there are no special handling or storage issues.
5. Calibration:
Auto-coding: No calibration is required from the user, since all test strips have the same one-code.
6. Quality Control:
One level of glucose control solution (Level II), is provided within the kit from the sponsor. An additional two levels Level I and Level III are available for purchase separately, as stated in the labeling. The labeling provides instructions on when to test control materials.. If the test results fall outside the range printed on the test strip vial, the user is instructed to contact the Customer Care Line at 1-
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877-342-2385 for customer support available 24 hours a day/7 days a week, except USA Federal Holidays.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
1. Altitude Study: An altitude study was performed in an altitude simulation chamber with whole blood samples obtained from 20 volunteers with the glucose range of 66 to 420 mg/dL. Each sample was tested with 4 glucose meters and one test strip lot. The study protocol, data and acceptance criteria of ±10 individual bias across the entire testing range were provided and found to be adequate. Altitudes up to 10,744 feet (3,275m) do not affect test results.
2. Hematocrit Study: A study to evaluate the effect of hematocrit was conducted on samples with 7 glucose concentrations (~25, ~75, ~150, ~270, ~380, ~470 and ~570 mg/dL). distributed across the measuring range and tested at 10 hematocrit levels (20, 25, 30, 35, 40, 45, 50, 55, 60, and 65%). Each glucose level/hematocrit combination was tested in duplicate of 10 using two test strip lots and 2 glucose meters. Results of samples at each hematocrit level were compared to samples with the same glucose concentration at normal (40%) hematocrit as well as to the corresponding YSI value. All results were within ±15% individual bias supporting the claimed hematocrit range of 20-60%.
3. Specimen volume study: A study was performed using samples in the range of 47 to 465 mg/dL to evaluate effect of different sample volumes (2.0μL, 1.0μL, 0.7 μL, 0.6μL and 0.5μL) on the performance of this device. Results of samples at each sample volume tested were compared to the corresponding YSI values. Results from these studies support the claimed sample volume of 0.7μL.
4. Lay user questionnaire: Lay users evaluated the ease of use of the device and the presentation of the labeling. All users thought that the AG-608 N/ AG-608 N MULTI Blood Glucose Monitoring Systems were easy to use and most answered "easy" and "very easy" to each question.
5. Disinfection studies: Infection Control Studies: The devices are intended for single-patient use (AG-608N Single Blood Glucose Monitoring System) or multiple-patient use (AG-608N Multi Blood Glucose Monitoring System). Disinfection efficacy studies were performed on the materials comprising the meters and lancing device by outside commercial testing demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, CaviWipes (EPA Registration #46781-8). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials for each of the meters and lancing device after 11,000 cleanings and 11,000 disinfection steps with the CaviWipes. The robustness studies were
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designed to stimulate 3 years of multiple-patient use and 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.
6. Data transfer study: The 40 study participants, following instructions in User's manual, were able to transmit results from the meter to the PC application (cleared under k102678) via USB. The study participants ranged in age, education, and were about equally divided between males and females. Those study participants also completed a questionnaire in response to whether the data transmission feature is easy to use. The sponsor concluded that the users' responses indicated that data transmission function was easy to operate by following the User's manuals.
7. Temperature and Humidity studies: The sponsor performed temperature and humidity studies using the AG-608 N glucose meter with venous whole blood samples at 5 glucose levels (<50, 50-100, 101-200, 201 - 400, >401 mg/dL). Results demonstrated that AG-608 N (meters and test strips) can be stored under conditions of 39 to 86°F and relative humidity of <80%. The test strip labeling states to store the test strips in a cool dry place between 39 to 86°F. Therefore, the storage conditions for the glucose meter listed in the User's manuals and supported by the studies are 39 to 86°F and <80% humidity.
8. Open-vial-in-use test strip studies were performed at the combined extremes of 10±2°C (46.4-56.3°F) RH: 12%, 10±2°C RH:88%, 40±2°C (100.4- 107.6°F) RH:11%, and 40±2°C RH:88% with venous whole blood samples at 3 glucose levels (~70, ~120 and 300 mg/dL). The study protocol, study data when individual measurements were compared to the YSI were reviewed and found to be adequate. Therefore, the operating conditions stated in the User's manual and supported by the studies are 50 to 104°F (10 to 40°C) with relative humidity of 25% to 80%.
9. The sponsor provided a readability study and obtained SMOG grade level scores of 8.0 or lower for the User's Manual, test strip insert and control insert.
10. Electromagnetic Compatibility (EMC) testing was performed/passed and a certificate to Andon was provided.
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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