TRUE METRIX GO Self Monitoring Blood Glucose System

K143548 · Trividia Health, Inc. · NBW · Apr 1, 2016 · Clinical Chemistry

Device Facts

• Record ID: K143548
• Device Name: TRUE METRIX GO Self Monitoring Blood Glucose System
• Applicant: Trividia Health, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose 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 TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes, for neonatal use or for alternative site testing. The TRUE METRIX Self Monitoring Blood Glucose Test Strips are for use with the TRUE METRIX GO Self Monitoring Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

Device Story

True Metrix Go is a portable blood glucose monitoring system for home use by patients with diabetes. System consists of a meter and test strips. Patient applies a fresh capillary whole blood sample from the fingertip to the test strip; meter performs electrochemical measurement of glucose concentration. Output is a digital glucose reading displayed on the meter. Device aids patients in monitoring diabetes control effectiveness. Intended for single-person use; not for neonatal or alternative site testing.

Clinical Evidence

Clinical user performance study conducted with 108 subjects comparing lay user fingerstick results to YSI reference method. Results showed 100% of samples within ±15 mg/dL for glucose <75 mg/dL and 100% within ±20% for glucose ≥75 mg/dL. Bench testing included precision, linearity (R²=0.9987), interference, hematocrit (20-70%), and altitude (up to 10,200 ft) studies, all meeting acceptance criteria.

Technological Characteristics

Electrochemical glucose test system; utilizes test strips for quantitative measurement of capillary whole blood glucose. Portable meter form factor for home use.

Indications for Use

Indicated for people with diabetes for quantitative measurement of glucose in fresh capillary whole blood from the fingertip to monitor diabetes control. Not for diagnosis, screening, neonatal use, or alternative site testing. Intended for single-patient use.

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.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k143548

B. Purpose for Submission:
New device

C. Measurand:
Capillary whole blood glucose from the fingertip

D. Type of Test:
Quantitative Amperometric assay (FAD-Glucose Dehydrogenase)

E. Applicant:
Trividia Health, Inc.

F. Proprietary and Established Names:
TRUE METRIX™ GO Blood Glucose Monitoring System

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1345, Glucose test system
2. Classification:
Class II
3. Product code:
NBW, System, Test, Blood Glucose, Over the Counter
LFR, Glucose Dehydrogenase, Glucose

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4. Panel:
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):
See indication(s) for use below.

2. Indication(s) for use:
The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.

The TRUE METRIX GO Self Monitoring Blood Glucose 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 TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use.

3. Special conditions for use statement(s):
- For In-Vitro Diagnostic Use Only.
- For over-the-counter use
- Not for screening or diagnosis of diabetes mellitus
- Not for use on critically ill patients, patients in shock, dehydrated patients or hyper-osmolar patients
- Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
- Capillary whole blood only from the fingertip may be used for testing
- Do not use on neonates
- For single-patient use only

4. Special instrument requirements:

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TRUE METRIXTM GO Blood Glucose Meter

# I. Device Description:

The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIX™ Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit.

True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

Bayer Ascensia Contour Blood Glucose Monitoring System

2. Predicate 510(k) number(s):

k062058

3. Comparison with predicate:

| Similarities of the Blood Glucose System | | |
| --- | --- | --- |
| Item | Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) | Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) |
| Intended Use/Indications for Use | It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. | same |
| Detection method | Electrochemical Biosensor | Same |
| Enzyme | FAD-Glucose Dehydrogenase | Same |
| Calibration Coding | Auto coding | Same |

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| Differences of the Blood Glucose System | | |
| --- | --- | --- |
| Item | Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) | Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) |
| Memory | 480 test results | 500 test results |
| Test range | 10 - 600 mg/dL | 20-600 mg/dL |
| Sample sites | Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood | Fresh Capillary Whole Blood from the fingertip |
| Sample volume | 0.6 μL | 0.5 μL |
| Hematocrit range | 0-70% | 20-70% |
| Altitude Study | Up to 10,000 feet | Up to 10,200 feet |
| Glucose measuring range | 10-600 mg/dL | 20-600 mg/dL |
| Operating Temperature | 41-113 °F | 40-86 °F |
| Operating Humidity | 10-93% RH | 10-80% RH |
| Glucose Assay Time | 5 seconds | 4-7 seconds |

K. Standard/Guidance Document Referenced (if applicable):

- IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility- Requirements and tests.
- CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products
- CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents
- CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline.

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L. Test Principle:

The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below:

| Glucose Level (mg/dL) | n | Strip Lot | Mean (mg/dL) | SD (mg/dL) | %CV |
| --- | --- | --- | --- | --- | --- |
| (22-28) | 100 | 1 | 24 | 1.0 | 4.2 |
| | | 2 | 22 | 0.9 | 4.3 |
| | | 3 | 22 | 0.9 | 4.0 |
| (36-44) | 100 | 1 | 38 | 1.4 | 3.7 |
| | | 2 | 38 | 1.5 | 3.9 |
| | | 3 | 36 | 1.4 | 3.7 |
| (76-84) | 100 | 1 | 75 | 2.2 | 3.0 |
| | | 2 | 74 | 2.4 | 3.2 |
| | | 3 | 73 | 2.6 | 3.5 |
| (133-147) | 100 | 1 | 138 | 3.8 | 2.8 |
| | | 2 | 137 | 5.0 | 3.6 |
| | | 3 | 139 | 4.8 | 3.4 |
| (190-210) | 100 | 1 | 206 | 7.3 | 3.6 |
| | | 2 | 203 | 6.7 | 3.3 |
| | | 3 | 206 | 6.5 | 3.2 |
| (304-336) | 100 | 1 | 291 | 10.9 | 3.7 |
| | | 2 | 294 | 10.1 | 3.4 |
| | | 3 | 299 | 7.4 | 2.5 |
| (475-525) | 100 | 1 | 490 | 12.7 | 2.6 |
| | | 2 | 495 | 15.0 | 3.0 |
| | | 3 | 509 | 12.7 | 2.5 |

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# Intermediate Precision

Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below:

| Control Level (mg/dL) | n | Strip Lot | Mean (mg/dL) | SD (mg/dL) | %CV |
| --- | --- | --- | --- | --- | --- |
| Level 1 | 100 | 1 | 37 | 1.5 | 4.0 |
| | | 2 | 38 | 1.8 | 4.8 |
| | | 3 | 36 | 1.4 | 3.9 |
| Level 2 | 100 | 1 | 112 | 4.1 | 3.6 |
| | | 2 | 115 | 4.0 | 3.5 |
| | | 3 | 116 | 3.6 | 3.1 |
| Level 3 | 100 | 1 | 312 | 10.1 | 3.2 |
| | | 2 | 319 | 12.6 | 3.9 |
| | | 3 | 322 | 10.6 | 2.8 |

## b. Linearity/assay reportable range:

Linearity was evaluated using venous whole blood samples at 9 different glucose levels. Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below:

$$
y = 1.012x + 0.754; \ R^2 = 0.9987 \ \text{for the combined lots}
$$

The results of the study support the sponsor’s claimed glucose measurement range of 20-600 mg/dL.

## c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability

The TRUE METRIX GO Self Monitoring Blood Glucose System is traceable to the NIST standard reference material SRM 917c glucose. The method comparison study was performed using the candidate device and YSI as the reference method (see Section 2.a.).

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# Stability

## TRUE METRIX Test Strip:

The test strip stability was assessed using real-time and accelerated testing. Protocols and acceptance criteria were adequate to support the shelf life claim of 36 months and open-vial stability claim of 4 months when stored at the recommended storage temperature of 40-86 °F (5-30°C) and 10-80% relative humidity (RH). The real time shelf life study and open vial study are still on going.

TRUE METRIX controls were previously cleared under k120989. Protocols and acceptance criteria were adequate to support a shelf life of 24 months and open-vial stability claim of 3 months when stored at the recommended storage temperature of 36-86°F.

## d. Detection limit:

Reference the device reportable range and the linearity studies (section M.1.b.).

## e. Analytical specificity:

To assess potential interference the sponsor used venous whole blood samples adjusted to two glucose concentrations, 80 mg/dL and 300 mg/dL. Each of these samples was divided into a test pool and a control pool and each of the potential endogenous and exogenous interfering substances was added to the test pool. Each substance was tested at one concentration. The % difference between the test samples and the control sample was calculated. The sponsor defines no significant interference as ≤ ±10% difference relative to the control sample. Results are presented in the table below:

| Potential Interfering Substance | Concentration at which no significant interference is observed (mg/dL) |
| --- | --- |
| Acetaminophen | 30 |
| Acetone | 20 |
| Ascorbic acid | 2 |
| Bilirubin | 15 |
| Caffeine | 6 |
| Ceftriaxone | 60 |
| Cholesterol | 500 |
| Creatinine | 5 |
| Dopamine | 0.1 |
| Ethanol | 400 |
| Sodium fluoride | 108 |
| Galactose | 15 |

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| Gentisic acid | 1.8 |
| --- | --- |
| Glipizide | 0.2 |
| Glutathione | 10 |
| Hemoglobin | 1400 |
| Ibuprofen | 50 |
| Icodextrin | 20 |
| L-Dopa | 4 |
| Maltose | 250 |
| Maltotetraose | 70 |
| Maltotriose | 180 |
| Metformin | 4 |
| Methyldopa | 1.5 |
| Naproxen Sodium | 50 |
| PAM | 21 |
| Salicylate | 70 |
| Tetracycline | 1.5 |
| Tolbutamide | 64 |
| Tolazamide | 5 |
| Triglycerides | 1000 |
| Uric acid | 5 mg/dL |
| Xylose | 7 |

## Limitations:

- Ascorbic acid (Vitamin C) greater than normal or therapeutic levels may cause significant interference resulting in inaccurate results at concentrations greater than 2 mg/dL.
- It is known that uric acid can interfere with this device at normal and disease levels, when uric acid concentrations are greater than 5 mg/dL. For people with diabetes, certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease this means you may have significant interference resulting in inaccurate glucose results and your blood glucose results may be not reliable. Please check with Doctor before using the TRUE METRIX, TRUE METRIX AIR or the TRUE METRIX GO Self Monitoring.
- Do not use during xylose absorption testing, as xylose may produce falsely elevated glucose results during a xylose absorption test for diagnostic evaluation of malabsorption. Please check with your doctor before using the True Metrix, True Metrix Air or True Metrix Go Self Monitoring Blood Glucose System.

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f. Assay cut-off:

Not applicable.

## 2. Comparison studies:

a. Method comparison with predicate device:

### Method comparison

To assess the system accuracy, results from the TRUE METRIX™ GO Blood Glucose Monitoring System were compared to a reference method, Yellow Springer Instruments (YSI) Blood Glucose Analyzer. Trained healthcare professionals obtained the capillary whole blood samples and results.

Capillary samples from 115 subjects with glucose ranging from 29-568 mg/dL were compared to the YSI reference method. Among those, 108 were unaltered, and 7 were altered (glycolyzed) to obtain glucose concentrations in the low range. The samples were tested using 12 meters and 3 lots of test strips. The results relative to the YSI reference method are summarized in the tables below:

TRUE METRIX GO User vs. YSI (Fingerstick)

| User Performance results for glucose concentration <75mg/dL | | | |
| --- | --- | --- | --- |
| Meter System | Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/d |
| TRUE METRIX GO | 9 / 12 (75%) | 11 / 12 (97.1%) | 12 / 12 (100%) |
| User Performance results for glucose concentration ≥75mg/dL | | | | |
| --- | --- | --- | --- | --- |
| Meter System | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| TRUE METRIX GO | 50 / 103 (48.5%) | 84 / 103 (81.6%) | 102 / 103 (99.0%) | 103 / 103 (100%) |

$$
y = 1.02x + 2.57; \ r2 = 0.99
$$

b. Matrix comparison:

Not applicable

## 3. Clinical studies:

a. Clinical Sensitivity:

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Not applicable.

b. Clinical specificity:

Not applicable.

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

User performance study

To assess the performance of the TRUE METRIX™ GO Blood Glucose Monitoring System in the hands of the intended users, a study was performed to compare the lay user self-test results and the reference method, Yellow Springs Instrument YSI) analyzer. The study was performed at one clinical site in the US with 108 subjects. During the lay user study, the participants were asked to complete a questionnaire to evaluate the ease of use of the device and the clarity of the English language labeling. Overall the users indicated that they could successfully perform the test and that the user manual was written clearly.

The study participants were provided with the Quick Reference Guide in English, and performed fingerstick tests on their own. A technician collected capillary blood from each participant for measurement on YSI. The range of glucose values for the finger stick samples was 46-568 mg/dL mg/dL measured by YSI reference method. One test strip lot and 3 meters were used in the study. The results are summarized below:

TRUE METRIX GO User vs. YSI (Fingerstick)

| User Performance results for glucose concentration <75mg/dL | | | |
| --- | --- | --- | --- |
| Meter System | Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
| TRUE METRIX GO | 5 / 7 (71.40%) | 7 / 7 (100%) | 7 / 7 (100%) |
| User Performance results for glucose concentration ≥75mg/dL | | | | |
| --- | --- | --- | --- | --- |
| Meter System | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| TRUE | 58 / 101 | 89 / 101 (88.1%) | 98 / 101 | 101 / 101 (100%) |
| METRIX GO | (57.4%) | | (97.0%) | |

$$
y = 1.00x + 1.86; r^2 = 0.98
$$

4. Clinical cut-off:

Not applicable.

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5. Expected values/Reference range:

Reference: American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care, January 2016: 39:S13-S22.

Expected Results for people without diabetes:

Plasma Blood Glucose Result1

Before eating &lt; 100 mg/dL

2 hours after a meal &lt;140 mg/dL.

N. Instrument Name:

TRUE METRIX™ GO Blood Glucose Meter

O. System Descriptions:

1. Modes of Operation:

Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?

Yes _______ or No ☐ X

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?

Yes _______ or No ☐ X

2. Software:

FDA has 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:

The glucose test is intended to be used with capillary whole blood from the finger. The whole blood sample is applied directly to the test strip by capillary action.

5. Calibration:

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There is no calibration required for the TRUE METRIX™ GO blood glucose meter by the user. The meter is automatically coded.

6. Quality Control:

Glucose control solutions at 3 different concentrations can be run with this device. The meter automatically distinguishes control solution from blood and marks control solution tests with a check mark and excludes them from average calculations. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the test strip bottle label or on the bottom of the test strip box. The user is cautioned not to use the meter if the control result falls outside these ranges.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

1. Sample volume study:

The sponsor performed a study to verify the test strip minimum sample volume requirement and the test strip fill error requirement established for the TRUE METRIX GO Blood Glucose Meter. Blood samples were tested at four sample volumes (0.3, 0.4, 0.5, and 0.6) and values obtained were compared to YSI values. Results support the claimed sample volume of 0.5 µL.

2. Altitude Study:

The effect of altitude was evaluated with 3 test strip lots tested on 5 meters using venous blood (spiked and glycolyzed) from 3 donors to 3 glucose concentrations (38-43, 121-127, 529-559). The samples were tested at 10,200 feet above sea level. Results obtained were compared with those obtained with the reference method (YSI). The results demonstrate acceptable bias to the reference to support the claims in the labeling that altitudes up to 10,200 feet have no significant effect on blood glucose measurements from the BGMS.

3. Hematocrit Study:

The effect of different hematocrit levels was evaluated using venous whole blood samples with hematocrit levels of 20 – 70% (20, 30, 42, 55 and 70%) spiked with glucose to achieve target concentrations of 40, 75, 120, 350, and 500 mg/dL. Results of samples at each hematocrit level were compared to samples with the same glucose concentration at normal (42%) hematocrit as well as to the corresponding YSI value. The % bias of the TRUEMETRIX GO meter results relative to YSI demonstrated adequate performance to support the claimed hematocrit range of 20 – 70%.

4. Test System operating conditions:

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Operating conditions were evaluated for temperatures ranging from 41°F-104°F (5°C-40°C) and relative humidity from 10% to 90% including extreme combinations of temperature and humidity. The following temperature and relative humidity (RH) conditions were tested: ≤5°C and 10% RH, ≤5°C and 90% RH, 20°C and 50% RH, 30°C and 50% RH, 40°C and 10% RH, 40°C and 90% RH. Individual glucose measurements were compared to the YSI reference method and a percent bias was calculated. Protocol and acceptance criteria were provided and found to be acceptable. The results supported the Sponsor's claimed operating temperature from 41°F-104°F and relative humidity range from 10% to 80%.

5. Readability Assessment:

The readability of the labeling (user guide, quick reference guide and test strip insert) using a Flesch-Kincaid analysis were found to be written at the 8th grade level.

6. EMC Testing:

The sponsor provided appropriate documentation certifying that electromagnetic testing (EMC) has been performed and the TRUE METRIX+ GO Blood Glucose Monitoring System was found compliant.

7. Infection Control Studies:

The device system is intended for single-patient use only. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Super Sani-Cloth Germicidal Wipes (EPA Registration # 9480-4). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleanings and 260 disinfection steps with the 580 wipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

8. Customer Support Center assistance, call 24/7 toll free 1-800-803-6025

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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