TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM

K140100 · Nipro Diagnostics, Inc. · NBW · Aug 1, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140100
• Device Name: TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Nipro Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX 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 Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The TRUE METRIX Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used for neonates or for the diagnosis or screening of diabetes. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm or venous whole blood.

Device Story

System measures glucose in capillary or venous whole blood via amperometric technology; utilizes glucose dehydrogenase-FAD reaction on plastic test strips. User inserts strip into meter; blood sample (0.5 μL) drawn into strip via capillary action; meter detects current, calculates glucose concentration, and displays plasma-equivalent value. Used at home (self-monitoring) or in professional healthcare settings (PRO version). Provides real-time glucose data to aid diabetes management; results used by patients or clinicians to monitor effectiveness of control. System includes meter, test strips, and control solutions. No coding required; calibration parameters embedded on strips.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on bench testing and technological comparison.

Technological Characteristics

Electrochemical glucose test system; consists of meter and disposable test strips. Supports capillary and venous whole blood samples. Professional version includes safety features for multi-patient use (auto-disabling lancing).

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood (fingertip/forearm) for self-testing by people with diabetes to monitor control; also indicated for venous whole blood (PRO version) in professional settings. Contraindicated for neonates, diabetes diagnosis/screening, and critically ill/shock/dehydrated/hyper-osmolar patients.

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 ONLY TEMPLATE

A. 510(k) Number:
k140100

B. Purpose for Submission:
Modification of test strip mediator from hexaammineruthenium (III) and Meldola’s Blue to Potassium ferricyanide (III)

C. Measurand:
Capillary whole blood glucose from the finger and forearm, and venous whole blood

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

E. Applicant:
Nipro Diagnostics, Inc.

F. Proprietary and Established Names:
TRUE METRIX Self Monitoring Blood Glucose System
TRUE METRIX PRO Professional Monitoring Blood Glucose System

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW – Glucose Test System | Class II | 862.1345 | Chem (75) |
| LFR – Glucose Test System | Class II | 862.1345 | Chem (75) |

H. Intended Use:
1. Intended use(s):
Refer to Indications for Use
2. Indication(s) for use:

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# TRUE METRIX Self Monitoring Blood Glucose System

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

The TRUE METRIX 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 Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The TRUE METRIX Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

# TRUE METRIX PRO Professional Monitoring Blood Glucose System

The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.

The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used for neonates or for the diagnosis or screening of diabetes. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm or venous whole blood.

3. Special conditions for use statement(s):

TRUE METRIX Self Monitoring Blood Glucose System

- For over-the-counter use
- Not for neonatal 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
- TRUE METRIX Self Monitoring System is for single-patient use only

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- Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
- AST should not be used to calibrate continuous glucose monitors (CGMs).
- AST should not be used for insulin dose calculations.

## TRUE METRIX PRO Professional Monitoring Blood Glucose System

- For use by healthcare professionals
- Not for neonatal use
- Not for screening or diagnosis of diabetes mellitus
- The TRUE METRIX PRO has not been validated for use on critically ill patients, patients in shock, dehydrated patients or hyper-osmolar patients
- TRUE METRIX PRO Professional System is for multiple-patient use and should only be used with single-use, auto-disabling lancing devices.
- Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
- AST should not be used to calibrate continuous glucose monitors (CGMs).
- AST should not be used for insulin dose calculations.

## 4. Special instrument requirements:

TRUE METRIX Self Monitoring Blood Glucose Meter

TRUE METRIX PRO Professional Monitoring Blood Glucose Meter

## I. Device Description:

The TRUE METRIX Self Monitoring Blood Glucose System and the TRUE METRIX PRO Professional Monitoring Blood Glucose Systems are comprised of the TRUE METRIX Self Monitoring Blood Glucose Meter or TRUE METRIX PRO Professional Monitoring Blood Glucose Meter, TRUE METRIX or TRUE METRIX PRO Test Strips, and TRUE METRIX glucose control solutions Level 1, 2, and 3. The TRUE METRIX glucose control solutions were cleared previously under k120989.

The meter, test strips and glucose control solutions may be marketed within a single package (Kit), or each of these components may be available for purchase separately or combined in different configurations. Labeling included with the complete System consists of a detailed instruction booklet (Owner's Booklet), test strip insert, control solution insert, quick reference card, log book for recording test results, and a carrying case.

## J. Substantial Equivalence Information:

### 1. Predicate device name(s):

TRUE METRIX Self Monitoring Blood Glucose System

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TRUE METRIX PRO Professional Monitoring Blood Glucose System

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

k132072

3. Comparison with predicate:

Similarities

| Item | Candidate Device | Predicate Device (k132072) |
| --- | --- | --- |
| | TRUE METRIX Self Monitoring Blood Glucose System | TRUE METRIX Self Monitoring Blood Glucose System |
| Intended Use | Same | It is intended to be used for quantitative measurement of glucose in capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. |
| Acceptable sample matrices | Same | Capillary whole blood samples from the fingertip or forearm |
| Sample Volume | Same | 0.5 μL |
| Measuring Range (mg/dL) | Same | 20 – 600 |
| Power Source | Same | One 3 volt lithium battery |
| Meter Memory Display | Same | 500 blood glucose test results; 1 control result |
| Test Time | Same | 4 seconds |
| Control Solution | Same | TRUE METRIX Control Solution Levels 1, 2, and 3 |
| Identification of Control Solution and Results | Same | Automatically distinguishes control solutions from whole blood samples |
| Hematocrit Range (%) | Same | 20 – 70 |
| Altitude | No effect up to 10, 200 ft. | No effect up to 10,150 ft. |
| Coding | Same | No coding required |

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Similarities (cont)

| Item | Candidate Device | Predicate Device (k132072) |
| --- | --- | --- |
| | TRUE METRIX Pro Professional Monitoring Blood Glucose System | TRUE METRIX Self Monitoring Blood Glucose System |
| Intended Use | Same as TRUE METRIX PRO Professional Monitoring Blood Glucose System cleared under k132072 | It is intended to be used for quantitative measurement of glucose in whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. |
| Acceptable sample matrices | Same | Capillary whole blood samples from the fingertip or forearm, and venous whole blood |
| Sample Volume | Same | 0.5 μL |
| Measuring Range (mg/dL) | Same | 20 – 600 |
| Power Source | Same | One 3 volt lithium battery |
| Meter Memory Display | Same | 500 blood glucose test results; 1 control result |
| Test Time | Same | 4 seconds |
| Control Solution | Same | TRUE METRIX Control Solution Levels 1, 2, and 3 |
| Identification of Control Solution and Results | Same | Automatically distinguishes control solutions from whole blood samples |
| Hematocrit Range (%) | Same | 20 – 70 |
| Altitude | No effect up to 10, 200 ft. | No effect up to 10,150 ft. |
| Coding | Same | No coding required |

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Differences

| Item | Candidate Device | Predicate Device (k132072) |
| --- | --- | --- |
| | TRUE METRIX Self Monitoring Blood Glucose System | TRUE METRIX Self Monitoring Blood Glucose System |
| Broken LCD Display Message | Broken LCD displays error message of two lines of three dashes across meter display | Broken LCD displays E-4 error message. |
| Interferents | Xylose, Uric acid, Ascorbic acid | Xylose |
| Mediator | Potassium ferricyanide (III) | hexaammineruthenium (III) and Meldola’s Blue |

Differences

| Item | Candidate Device | Predicate Device (k132072) |
| --- | --- | --- |
| | TRUE METRIX PRO Professional Monitoring Blood Glucose System | TRUE METRIX PRO Professional Monitoring Blood Glucose System |
| Broken LCD Display Message | Broken LCD displays error message of two lines of three dashes across meter display | Broken LCD displays E-4 error message. |
| Interferents | Xylose, Uric acid, Ascorbic acid | Xylose |
| Acceptable sample types | Capillary (fingertip and forearm) and venous (Sodium heparin only) | Capillary (fingertip and forearm) and venous (Sodium heparin, Lithium heparin, EDTA) |
| Mediator | Potassium ferricyanide (III) | hexaammineruthenium (III) and Meldola’s Blue |

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

1. EN ISO 15197: In Vitro Diagnostic Test Systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus, 2003
2. ISO 14197: Medical Devices - Application of risk management to medical devices, 2007
3. CLSI GP14-A: Labeling of Home-Use In Vitro Testing Products, 1996

L. Test Principle:

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The TRUE METRIX/TRUE METRIX PRO Blood Glucose Test Strip is a plastic strip containing chemicals and electrodes. When inserted into a TRUE METRIX Meter, glucose is measured using amperometric technology employing a glucose dehydrogenase-FAD reaction. When whole blood or TRUE METRIX Glucose Control Solutions are drawn into the sample well of the strip, glucose in the sample reacts with the chemicals and produces an electrical current. The meter measures the current and calculates the amount of glucose. The result is displayed as a plasma equivalent value.

## M. Performance Characteristics (if/when applicable):

1. Analytical performance: Please note: The TRUE METRIX Self Monitoring Blood Glucose System and TRUE METRIX PRO Professional Monitoring Blood Glucose System are identical and the performance characteristics below are applicable to both systems.

### a. Precision/Reproducibility:

The sponsor performed precision studies using venous whole blood collected into sodium heparin collection tubes. The samples were spiked to five different glucose concentration ranges and 100 samples were prepared at each glucose concentration. One operator collected the results using three test strip lots and ten meters. Results are summarized below:

Within-lot precision for glucose: Lot 1

| Glucose Level | Number of tests | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- | --- |
| 1 | 100 | 44 | 1.6 | 3.6 |
| 2 | 100 | 89 | 3.6 | 4.0 |
| 3 | 100 | 150 | 4.9 | 3.3 |
| 4 | 100 | 208 | 7.4 | 3.6 |
| 5 | 100 | 329 | 9.6 | 2.9 |

Within-lot precision for glucose: Lot 2

| Glucose Level (mg/dL) | Number of tests | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- | --- |
| 1 | 100 | 44 | 1.8 | 4.1 |
| 2 | 100 | 84 | 2.4 | 2.9 |
| 3 | 100 | 140 | 4.3 | 3.1 |
| 4 | 100 | 201 | 6.3 | 3.1 |
| 5 | 100 | 317 | 8.0 | 2.5 |

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Within-lot precision for glucose: Lot 3

| Glucose Level (mg/dL) | Number of tests | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| --- | --- | --- | --- | --- |
| 1 | 100 | 43 | 1.7 | 4.0 |
| 2 | 100 | 85 | 2.5 | 2.9 |
| 3 | 100 | 140 | 3.8 | 2.7 |
| 4 | 100 | 199 | 7.3 | 3.7 |
| 5 | 100 | 316 | 8.7 | 2.8 |

Intermediate precision was evaluated using three levels of glucose control solutions with concentrations in the ranges below using three test strip lots. Per lot, each control level was measured ten times per day over ten days using ten meters, for a total of 100 results per control level per strip lot. Results are summarized below.

Between-day precision for glucose: Lot 1

| Glucose Level (mg/dL) | Number of tests | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- |
| 21 to 51 | 100 | 33 | 1.4 | 4.2 |
| 97 to 131 | 100 | 108 | 3.8 | 3.5 |
| 281 to 381 | 100 | 313 | 8.8 | 2.8 |

Between-day precision for glucose: Lot 2

| Glucose Level (mg/dL) | Number of tests | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- |
| 19 to 49 | 100 | 33 | 1.6 | 4.8 |
| 93 to 125 | 100 | 105 | 3.8 | 3.6 |
| 270 to 366 | 100 | 306 | 10.3 | 3.4 |

Between-day precision for glucose: Lot 3

| Glucose Level (mg/dL) | Number of tests | Mean (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- |
| 19 to 49 | 100 | 33 | 1.5 | 4.5 |
| 92 to 124 | 100 | 106 | 3.5 | 3.3 |
| 265 to 359 | 100 | 303 | 8.6 | 2.8 |

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b. Linearity/assay reportable range:

Linearity was evaluated using three test strip lots and nine mixed pools of venous blood with glucose concentrations of 22, 42, 88, 159, 251, 318, 412, 503, and 592 mg/dL as measured by the YSI reference method. Each level was measured in replicates of ten with each of three test strip lots and the values from the candidate meter were compared with those obtained from the YSI2300. Results from linear regression analysis are summarized below:

Test strip lot #1: $y = 0.9804x - 3.7435$ ; $r^2 = 0.9996$

Test strip lot #2: $y = 0.967x - 2.3211$ ; $r^2 = 0.9995$

Test strip lot #3: $y = 0.9994x - 1.3666$ ; $r^2 = 0.9994$

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 Self Monitoring Blood Glucose System and the TRUE METRIX Pro™ Professional Monitoring Blood Glucose System are traceable to the NIST SRM 917c glucose standard. The method comparison study was performed using the candidate device and YSI 2300 glucose analyzer as the reference method.

Test Strip Stability

Test strip stability was assessed in accelerated studies. The manufacturer claims a shelf life stability of 21 months and an open-vial stability of 4 months at the recommended storage temperatures of $40^{\circ}\mathrm{F}$ to $86^{\circ}\mathrm{F}$ and $10 - 85\%$ relative humidity (RH). Real-time studies are ongoing.

Control solution value assignment and stability were established in k120989. The sponsor claims that the shelf life stability is 24 months and the open-vial stability is 3 months when stored at the recommended storage temperatures of $36^{\circ}\mathrm{F}$ to $86^{\circ}\mathrm{F}$ .

d. Detection limit:

The measuring range of the device is $20 - 600\mathrm{mg / dL}$ . This range was validated by the linearity study (M.1.b).

e. Analytical specificity:

Interference studies were performed by spiking venous blood to two levels of glucose

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concentrations (approximately 80 and 300 mg/dL). Each of these samples was then divided into three aliquots; one containing the potential interferent at the normal/therapeutic level, one containing the potential interferent at the abnormal/toxic level, and the third as a control sample. According to the sponsor, significant interference is considered to occur if the bias between spiked sample glucose results and control sample glucose results is > ± 10%.

| Potential Interfering Substance | Highest concentration tested that did not cause interference (mg/dL) |
| --- | --- |
| Acetaminophen | 30 |
| Acetone | 20 |
| Ascorbic Acid | 2 |
| Bilirubin | 15 |
| Caffeine | 6 |
| Cholesterol | 250 |
| Creatinine | 5 |
| Dopamine | 0.1 |
| Ethanol | 400 |
| Galactose | 15 |
| 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 |
| Paralidoxime Iodide | 21 |
| Salicylate | 70 |
| Tetracycline | 1.5 |
| Tolazamide | 5 |
| Tolbutamide | 64 |
| Triglycerides | 1000 |
| Uric Acid | 5 |
| Xylose | 7 |

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The sponsor has the following limitations in their labeling:

- Ascorbic acid may cause interference at concentrations greater than 2 mg/dL.
- Uric acid may cause interference at concentrations greater than 5 mg/dL.
- Do not use the TRUE METRIX System during a xylose absorption test. This may falsely raise glucose results.
- Use fresh, capillary whole blood from the fingertip or forearm. Venous whole blood drawn into only a sodium heparin blood collection tube may also be used for testing. Mix well before sampling. Do not use venous whole blood collected in sodium fluoride blood collection tubes for testing, as this may cause false low results.

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

The sponsor performed a study to assess the performance of the TRUE METRIX Self-Monitoring Blood Glucose System. One hundred (100) fingerstick samples and one hundred (100) forearm samples were collected in separate studies. Results were analyzed by comparing blood glucose results from the TRUE METRIX meter obtained by the lay user against the YSI reference value. The samples ranged from 34 - 494 mg/dL (fingerstick) and 58 to 308 mg/dL (forearm) as measured by YSI. The results are summarized in the tables below:

Fingerstick samples

| Glucose concentrations < 75 mg/dL | | |
| --- | --- | --- |
| within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL |
| 2 / 3 (66.7%) | 3 / 3 (100%) | 3 / 3 (100%) |
| Glucose concentrations ≥ 75 mg/dL | | | |
| --- | --- | --- | --- |
| within ± 5% | within ± 10% | within ± 15% | within ± 20% |
| 46 / 97 (47.4%) | 76 / 97 (78.4%) | 95 / 97 (97.9%) | 97 / 97 (100%) |
| Linear regression analysis | |
| --- | --- |
| n | 100 |
| slope | 1.05 |
| y-intercept | -2.51 |
| r² | 0.99 |
| range (mg/dL) | 34 - 494 |

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Forearm samples

| Glucose concentrations < 75 mg/dL | | |
| --- | --- | --- |
| within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL |
| 2 / 4 (50.0%) | 3 / 4 (75.0%) | 4 / 4 (100%) |
| Glucose concentrations ≥ 75 mg/dL | | | |
| --- | --- | --- | --- |
| within ± 5% | within ± 10% | within ± 15% | within ± 20% |
| 37 / 96 (38.5%) | 63 / 96 (65.6%) | 91 / 96 (94.8%) | 96 / 96 (100%) |
| Linear regression analysis | |
| --- | --- |
| n | 100 |
| slope | 1.04 |
| y-intercept | 3.79 |
| r² | 0.98 |
| Range (mg/dL) | 58 – 308 |

## b. Matrix comparison:

To assess the performance of the TRUE METRIX PRO Professional Monitoring Blood Glucose System using venous blood, 110 venous samples were collected into sodium heparin collection tubes. An additional eleven samples were spiked or allowed to glycolyze to obtain enough values $&lt; 50\mathrm{mg/dL}$ or $&gt;400\mathrm{mg/dL}$. The final range of glucose concentrations as measured by the reference method was 36 to 539 mg/dL. The results obtained from the True Metrix BGMS were compared to results obtained using the reference method (YSI). Results are summarized below:

| Glucose concentrations < 75 mg/dL | | |
| --- | --- | --- |
| within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL |
| 7 / 7 (100%) | 7 / 7 (100%) | 7 / 7 (100%) |
| Glucose concentrations ≥ 75 mg/dL | | | |
| --- | --- | --- | --- |
| within ± 5% | within ± 10% | within ± 15% | within ± 20% |
| 66 / 114 (58%) | 103 / 114 (90%) | 112 / 114 (98%) | 114 / 114 (100%) |
| Linear regression analysis | |
| --- | --- |
| n | 121 |
| slope | 0.99 |
| y-intercept | 5.40 |
| r² | 0.99 |
| Range (mg/dL) | 36 - 539 |

Only sodium heparin venous samples may be used with this blood glucose system.

## 3. Clinical studies:

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a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data:

Not applicable

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

Expected Results for people without diabetes*:

Plasma Blood Glucose Result Before eating &lt; 100 mg/dL

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

* American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus.

Diabetes Care, Volume 37, Supplement 1, January 2014.

N. Instrument Names:

TRUE METRIX Self Monitoring Blood Glucose Meter

TRUE METRIX PRO Professional Monitoring Blood Glucose Meter

O. System Descriptions:

1. Modes of Operation

Each test strip is single use and requires a sample volume of 0.5 mL.

2. Software:

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

Yes ☐ X ☐ or No ☐

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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 device is intended to be used with venous whole blood and capillary whole blood from the finger or forearm only. The whole blood sample is applied directly to the test strip by capillary action.

5. Calibration:

This is a no-coding system: Test strip lot-specific calibration is accomplished by embedding the Calibration Code onto each test strip, which then provides the Calibration Code information to the meter when the test strip is inserted into the meter. The test strip provides the meter with the optimal Calibration Code parameters determined for the specific test strip lot.

6. Quality Control:

Three levels of aqueous glucose control solutions are available with this system (Manufactured by Bionostics, Inc.). Control solutions are sold separately. When a control solution is applied, the meter automatically detects and identifies the glucose control sample prior to displaying the glucose measurement. The meter identifies that the measurement is from a control sample by displaying the "Control Symbol" in the meter display. Recommendations on when to test the control materials are provided in the labeling. The control solution readings are not included in the average of the patient results. An acceptable range for each control level is printed on the test strip vial label. 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. Customer Service Availability. The True Metrix Customer Care Service Center is available 24 hours a day, 365 days a year by calling 1-800-803-6025.
2. Hematocrit. The effect of different hematocrit levels on the performance of the TRUE METRIX Blood Glucose System was evaluated using venous whole blood samples with hematocrit levels of 20, 30, 42, 55, and 70%, at glucose concentrations of 40, 75, 120, 350, and 500 mg/dL. Each sample was then tested 10 times using the TRUE METRIX meter and the values were compared with those obtained from YSI analyzer. The results supported the sponsor's claim that hematocrit values from 20 – 70% will produce accurate glucose results.
3. Sample volume. The recommended minimum sample volume for this device is 0.5μL. To evaluate the effect of sample volume, the sponsor performed a study using

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eight meters, three test strip lots, and sample sizes of 0.3, 0.4, 0.5, and 0.6 µL. The sample volumes smaller than recommended produced an error code and no results, while the recommended and larger sample volumes produced accurate results. These results support the sponsor’s claimed minimum sample size of 0.5 µL.

4. **Temperature and Humidity.** The sponsor performed temperature and humidity studies using venous blood samples at 70, 250 and 500 mg/dL to evaluate the effect of combined temperature and humidity conditions. Temperatures ranging from 5° to 40°C (41 to 104 °F) and relative humidity from 10% to 90% were evaluated and meter results were compared to YSI values. No significant bias (relative to YSI) was observed with the temperature and humidity combinations tested. These results obtained at the extremes of the claimed temperature and humidity ranges support the claims in the labeling that the system can be used in conditions of 41° to 104°F (5° to 40°C) with relative humidity of 10 to 90%.

5. **Altitude.** Venous whole blood samples were collected into sodium heparin anticoagulant tubes and adjusted to low, mid, and high target glucose concentrations. The actual reference concentrations to which the meter measurements were compared ranged from 38-43 mg/dL, 121-127 mg/dL, and 521-559 mg/dL, respectively. These samples were then tested at an altitude of 10, 200 feet and compared to the YSI reference measurement. The study evaluated three test strip lots using five meters per lot. The results demonstrate acceptable bias and indicate acceptable performance to the claimed altitude of 10,200 ft.

6. **Infection control.** There were no changes to the exterior materials of the device. Please see summary of infection control studies in k120989.

7. **EMC testing.** The sponsor states that Electromagnetic Compatibility was not affected by the modifications made (the addition of uric acid and ascorbic acid as interferents as the result of a mediator change, and a change in error message displayed in the case of a broken LCD display.). EMC testing was performed by Intertek Testing Services NA Inc. for the predicate device in k120989. Verification of Compliance certificates were provided and testing was found to be adequate.

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.