BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650

K120423 · Bionime Corporation · NBW · Aug 3, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120423
• Device Name: BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM650 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 Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strip GS650 is for use with the Rightest Blood Glucose meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm. The Rightest Control Solution GC650 is for use with the Rightest Blood Glucose meter GM650 and Rightest Blood Glucose Test Strips GS650 to check that the meters and test strip are working together properly and that the test is performing correctly. The GE Talking Blood Glucose Monitoring System Model GE300 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The GE Talking Blood Glucose Monitoring System Model GE300 is intended to be used by a single person and should not be shared. The GE Talking Blood Glucose Monitoring System Model GE300 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 GE Talking Blood Glucose Monitoring System Model GE300 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE300 Blood Glucose Test Strip is for use with the GE talking blood glucose monitoring system Model GE300 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm. The GE300 Control Solution Set is for use with the GE talking blood glucose monitoring system Model GE300 and GE300 Blood Glucose Test Strips to check that the meters and test strip are working together properly and that the test is performing correctly.

Device Story

System measures capillary whole blood glucose via amperometric assay using FAD-glucose dehydrogenase enzyme. User applies blood sample to test strip; meter performs electrochemical measurement; displays glucose concentration. Designed for single-patient home use; includes lancing device and control solutions for verification. GE300 model includes voice output for audible information. Provides quantitative results to aid diabetes management; not for diagnostic screening or neonatal use. Requires steady-state glucose levels for alternative site testing. Meter stores results for trend analysis.

Clinical Evidence

Clinical accuracy study (n=118) compared meter values to lab plasma glucose values; met acceptance criteria. User performance study (n=161) confirmed lay consumers could obtain accurate results using fingertip, palm, and forearm sites. Bench testing included precision, linearity, interference, and hematocrit evaluations.

Technological Characteristics

Electronic meter utilizing electrical characteristic technology (FAD-glucose dehydrogenase). Requires 1 microliter blood sample. Features auto-coding. Digital display. Standalone device. Software-driven processing.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertips, palm, or forearm in people with diabetes for home monitoring of diabetes control. Contraindicated for neonatal use, diagnosis/screening of diabetes, critically ill patients, patients in shock, dehydration, or hyper-osmolar states. Not for use by visually impaired 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.

Predicate Devices

• Rightest™ Blood Glucose Monitoring System, Model GM550 (k092052)

Submission Summary (Full Text)

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

A. 510(k) Number:
k120423

B. Purpose for Submission:
Clearance of new device

C. Measurand:
Capillary whole blood glucose

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

E. Applicant:
Bionime Corporation

F. Proprietary and Established Names:
Bionime Rightest™ Blood Glucose Monitoring System, Model GM650
GE Talking Blood Glucose Monitoring System, Model GE300

G. Regulatory Information:
1. Regulation section:
21 CFR: 862.1345, Blood Glucose Test System
21 CFR 862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class II
Class I, reserved
3. Product code:
NBW – System, Test, Blood Glucose, Over the Counter
LFR- Glucose Dehydrogenase
JJX - Quality Control Material (Assayed and Unassayed)

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4. Panel:

75 (clinical chemistry)

H. Intended Use:

1. Intended use(s):

Same as indications for use

2. Indication(s) for use:

Bionime Rightest™ Blood Glucose Monitoring System, Model GM650

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM650 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 Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strip GS650 is for use with the Rightest Blood Glucose meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.

The Rightest Control Solution GC650 is for use with the Rightest Blood Glucose meter GM650 and Rightest Blood Glucose Test Strips GS650 to check that the meters and test strip are working together properly and that the test is performing correctly.

GE Talking Blood Glucose Monitoring System, Model GE300

The GE Talking Blood Glucose Monitoring System Model GE300 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The GE Talking Blood Glucose Monitoring System Model GE300 is intended to be used by a single person and should not be shared.

The GE Talking Blood Glucose Monitoring System Model GE300 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 GE Talking Blood Glucose Monitoring System Model GE300 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

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The GE300 Blood Glucose Test Strip is for use with the GE talking blood glucose monitoring system Model GE300 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.

The GE300 Control Solution Set is for use with the GE talking blood glucose monitoring system Model GE300 and GE300 Blood Glucose Test Strips to check that the meters and test strip are working together properly and that the test is performing correctly.

3. Special conditions for use statement(s):

- 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
- For single-patient use only
- 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.
- The GM650 and GE300 BGMS are NOT intended for use by visually impaired patients, therefore, the kit boxes and labeling indicate “Only limited audible information is available”.

4. Special instrument requirements:

Rightest GM650 Blood Glucose Meter

GE Talking Blood Glucose Meter, Model GE300

I. Device Description:

The Rightest Blood Glucose Monitoring System Model GM650 consists of a the Rightest GM650 Blood Glucose meter, the Rightest Blood Glucose Test Strips GS650, three levels of Control Solutions, Rightest GD500 Lancing Device for single patient use only and lancets, clear cap (sold separately), carry case, and User Manual.

Each test strip contains the following reagent compositions: flavin adenine dinucleotide-glucose dehydrogenase (9.0% FAD-GDH from Aspergillus Oryzae); potassium ferricyanide (53.7%); and other non-reactive ingredients.

Each box of control solutions contains one vial (4.0 mL) of each aqueous control solution, each: Level 1 (40-50 mg/dL), Level 2 (120 to 150 mg/dL), Level 4 (330 to 360 mg/dL).

GE300 Talking BGMS and Rightest BGMS GM650 meters are identical to each other in every way and share the following components tabulated below:

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| Rightest Name | Code | GE Name and code |
| --- | --- | --- |
| Meter | GM650 | GE300 Talking Blood Glucose Meter |
| Test Strip (10 or 25 strips) | GS650 | GE300 Talking Blood Glucose Test Strip (10 or 25 strips) |
| Control Solution Set (Level 1, Level 2, and Level 4) | GC650 | GE300 Talking Blood Glucose Control Solution Set (Level 1, Level 2, and Level 4 Levels) |
| Lancing Device | GD500 | GE Lancing Device |
| Lancets | GL300 | Lancets |

The control solutions: L1, L2, L3, L4 and L5 were cleared under k110737 on March 29, 2012. Low (L1), Normal (L2) and High (L4) levels are included in this submission which have been renamed as Level 1, Level 2 and Level 4. The indications for use and labeling are modified accordingly.

The test strips to be used with GM650 and GE300 meters are the same as the GM 700 strips that have been cleared under k110737.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Rightest Blood Glucose Monitoring System Model GM550
Rightest Control Solutions GC550

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

k092052 and k110737

2. Comparison with predicate:

| Similarities and Differences of the Blood Glucose System | | |
| --- | --- | --- |
| Item | Predicate Device
Rightest Blood Glucose Monitoring System, Model GM550
(k092052) | Candidate Device
Rightest Blood Glucose Monitoring System
GM650 and GE Talking Blood Glucose Monitoring System, Model GE300 |
| 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 |

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| Setting | At home and in a clinical settings | Only for single patient use at home |
| --- | --- | --- |
| Detection method | Amperometry | Same |
| Enzyme | Glucose Oxidase | FAD-Glucose Dehydrogenase |
| Calibration Coding | Auto code | Same |
| Memory | 500 control and glucose (1, 7, 14, 30, 90 day average) | Same |
| Test range | 20 - 600 mg/dL | Same |
| Hematocrit range | 30 - 60% | 30-55% |
| Sample type | Capillary whole blood | Same |
| Sample sites | Fingertip, forearm, palm | Same |
| Sample volume | 0.75 μL | 1 μL |
| Voice function | No | Yes |

Similarities and Differences of the control solution

| Predicate Device
Rightest Control Solutions GC550
(k110737) | Candidate Device
Rightest Control Solutions
GC650 |
| --- | --- |
| To check that the glucose meter and test strips are working together properly | Same |
| Viscosity-adjusted, aqueous liquid | Same |
| 5 levels | 3 levels L1, L2 and L4 |

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

- ISO 15197: In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
- ISO 14971:2007, Medical devices – Application of risk management to medical devices.
- CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline.
- IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility- Requirements and tests.
- IEC 60601-1, Medical Electrical Equipment-Part 1: General Requirements for Safety.
- IEC 61000-4-2 Electromagnetic compatibility (EMC)-Part 4-2: Testing and measurement techniques-Electrostatic discharge immunity test.: 2008
- IEC 61000-4-3: Electromagnetic compatibility (EMC) – Part 4-3 2006+A1:2007: Testing and measurement techniques-Radiated, radio-frequency, electromagnetic field immunity test.
- IEC 61000-4-8, Electromagnetic compatibility (EMC)-Part 4-8: Testing and measurement techniques-Power frequency magnetic field immunity test.

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L. Test Principle:

The Rightest Blood Glucose Monitoring System, Model GM650 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):

The Blood Glucose Monitoring Systems - GE300 Talking BGMS and Rightest BGMS GM650 meters are identical to each other except for the trade names. Therefore performance characteristics for only Rightest Blood Glucose Monitoring System GM650 have been provided.

1. Analytical performance:

a. Precision/Reproducibility:

The sponsor performed precision studies in accordance with the ISO 15197 and CLSI EP-5A. Venous whole blood was adjusted to 5 glucose levels 30-50mg/dL, 51-110mg/dL, 111-150mg/dL, 151-250mg/dL, 251-400mg/dL) were used for within-day precision studies. Each glucose level was analyzed in replicates of 10, with 3 test strip lots and 10 meters, for a total of 300 tests per glucose level. Results are summarized below:

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Strip Lot No.:Y1650JL01A

| | Sample | P-01 | P-02 | P-03 | P-04 | P-05 |
| --- | --- | --- | --- | --- | --- | --- |
| N | | 100 | 100 | 100 | 100 | 100 |
| Mean | mg/dL | 47.0 | 77.9 | 139.4 | 221.6 | 352.7 |
| SD | mg/dL | 1.7 | 1.5 | 3.0 | 4.4 | 7.7 |
| CV | % | 3.7% | 1.9% | 2.2% | 2.0% | 2.2% |

Strip Lot No.:Y1650JK22A

| | Sample | P-01 | P-02 | P-03 | P-04 | P-05 |
| --- | --- | --- | --- | --- | --- | --- |
| N | | 100 | 100 | 100 | 100 | 100 |
| Mean | mg/dL | 46.7 | 78.2 | 140.3 | 219.8 | 349.8 |
| SD | mg/dL | 1.6 | 1.6 | 2.5 | 3.9 | 6.5 |
| CV | % | 3.5% | 2.1% | 1.8% | 1.8% | 1.9% |

Strip Lot No.:Y1650JK23A

| | Sample | P-01 | P-02 | P-03 | P-04 | P-05 |
| --- | --- | --- | --- | --- | --- | --- |
| N | | 100 | 100 | 100 | 100 | 100 |
| Mean | mg/dL | 46.8 | 78.0 | 139.2 | 222.8 | 352.7 |
| SD | mg/dL | 1.5 | 1.6 | 2.8 | 4.2 | 8.6 |
| CV | % | 3.2% | 2.0% | 2.0% | 1.9% | 2.4% |

In addition to the study above, the sponsor also evaluated day-to-day precision using three levels of glucose control solution samples (32-48 mg/dL, 102-138 mg/dL, 317-429 mg/dL). Three lots of test strips and 10 meters were used in the study, with 1 test performed on each meter per day for 10 days, with 3 test strip lots, and 10 meters for a total of 300 tests per glucose level. Results are summarized below:

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Y1650JL01A

| | Sample | CS-L | CS-N | CS-H |
| --- | --- | --- | --- | --- |
| N | | 100 | 100 | 100 |
| Mean | mg/dL | 47.42 | 127.91 | 375.58 |
| SD | mg/dL | 1.4 | 4.6 | 9.7 |
| CV | % | 2.9% | 3.6% | 2.6% |

Y1650JK22A

| | Sample | CS-L | CS-N | CS-H |
| --- | --- | --- | --- | --- |
| N | | 100 | 100 | 100 |
| Mean | mg/dL | 48.05 | 126.07 | 376.84 |
| SD | mg/dL | 1.6 | 5.9 | 10.6 |
| CV | % | 3.4% | 4.7% | 2.8% |

Y1650JK23A

| | Sample | CS-L | CS-N | CS-H |
| --- | --- | --- | --- | --- |
| N | | 100 | 100 | 100 |
| Mean | mg/dL | 47.42 | 127.73 | 375.39 |
| SD | mg/dL | 1.4 | 4.8 | 10.3 |
| CV | % | 3.0% | 3.8% | 2.7% |

# b. Linearity/assay reportable range:

Linearity was evaluated using three test strip lots and 15 mixed pools of venous blood samples in glucose concentrations (as measured by YSI) of 0, 9, 29, 50, 86, 154, 210, 238, 325, 346, 401, 462, 492, 591, and $629\mathrm{mg / dL}$ . Each level was measured in triplicate with each of 3 test strip lots and the values from the Rightest GM650 meter were compared with those obtained from YSI-2300. Results from regression analysis:

Test strip lot #1: $y = 1.0025x - 0.0664$ ; $R^2 = 0.9956$

Test strip lot #2: $y = 1.0226x - 5.0090$ ; $R^2 = 0.9963$

Test strip lot #3: $y = 1.0009x + 1.8628$ ; $R^2 = 0.9952$

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

The measuring range of these systems is 20-600 mg/dL. Results equal to or below 20 mg/dL are reported as “Lo” and results greater than or equal to 600 mg/dL reported as “Hi.”

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

Control solutions and test strips cleared under k110737.

Traceability:
The Bionime Rightest Model GM650 Blood Glucose Monitoring System is traceable to the NIST SRM 917A reference material.

d. Detection limit:

The measuring range of the system is 20-600 mg/dL. This range was verified by the linearity study (M.1.b).

e. Analytical specificity:

Interference studies were performed by spiking venous blood with two levels of glucose concentrations (60 - 100 and 150 - 300 mg/dL). Each of these samples was divided into a test pool and a control pool and each of 18 potential endogenous and exogenous interfering substances was added to the test pool. Each compound was tested at two concentrations, normal/therapeutic and high/toxic concentrations.

Each sample was analyzed 5 times with the Rightest GM650 meter and the % difference between the interferent containing sample and the control sample calculated. The sponsor defines no significant interference as ≤10% difference relative to the control sample. Results are presented in the table below:

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| Potential Interfering Substance | Concentration with no Significant Interference (mg/dL) | | Potential Interfering Substance | Concentration with no Significant Interference (mg/dL) |
| --- | --- | --- | --- | --- |
| Acetaminophen | 20 | | Salicylic Acid | 20 |
| Ascorbic Acid | 6 | | Tetracycline | 1.5 |
| Bilirubin | 40 | | Tolbutamide | 100 |
| Cholesterol | 500 | | Triglycerides | 1700 |
| Creatinine | 10 | | Uric Acid | 10 |
| Dopamine | 2.5 | | Maltose | 200 |
| Ibuprofen | 50 | | Galactose | 50 |
| L-Dopa | 3.0 | | Lactose | 50 |
| Methyldopa | 1.5 | | Xylose | 10 |

The sponsor has the following limitations in their labeling: Xylose concentrations $\geq 10\mathrm{mg / dL}$ and Uric acid $\geq 10\mathrm{mg / dL}$ may interfere with the test resulting in inaccurate test results.

f. Assay cut-off:

Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

The sponsor states that this study was performed in accordance with ISO 15197.

Testing was completed by comparing the Rightest Blood Glucose Monitoring System against the YSI-2300 glucose analyzer (reference method). The study was conducted with a total 118 subjects. Three lots of test strips were used in the study.

Fresh venous blood samples and capillary blood from fingertip, palm and forearm (ranging between $30 - 528\mathrm{mg / dL}$ glucose concentrations) from different individuals were used, except for five samples with glucose concentrations $< 50\mathrm{mg / dL}$ that were incubated to allow glucose to glycolize. For concentrations $>400\mathrm{mg / dL}$, four spiked samples were used. Samples collected from fingertip, palm and forearm were tested with the Rightest GM 650 and within 5 minutes was also tested with the YSI meter.

Accuracy for first Rightest GM650 measurement results vs. YSI results are summarized below:

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For blood glucose concentration < 75 mg/dL

| Rightest GM650 | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- | --- |
| Fingertip | 13/15(86.7%) | 15/15(100.0%) | 15/15(100.0%) |
| Palm | 12/15(80.0%) | 15/15(100.0%) | 15/15(100.0%) |
| Forearm | 11/15(73.3%) | 15/15(100.0%) | 15/15(100.0%) |

For blood glucose concentration ≥ 75 mg/dL

| Rightest GM650 | Within ± 5 % | Within ± 10 % | Within ±15 % | Within ± 20% |
| --- | --- | --- | --- | --- |
| Fingertip | 67/103(65.0%) | 92/103(89.3%) | 101/103(98.1%) | 103/103(100.0%) |
| Palm | 56/103(54.4%) | 88/103(85.4%) | 102/103(99.0%) | 103/103(100.0%) |
| Forearm | 46/103(44.7%) | 75/103(72.8%) | 100/103(97.1%) | 102/103(99.0%) |

Results met the criteria from ISO 15197 that states: 95% of the individual glucose results shall fall within ±15 mg/dL when glucose concentration less than 75 mg/dL and within ±20% when glucose concentration ≥75 mg/dL.

Linear Regression analysis

| Comparison vs. YSI | Test strip lot | Range of values (mg/dL) | slope | intercept | R |
| --- | --- | --- | --- | --- | --- |
| Finger | 1 | 29-533 | 0.998 | -2.83 | 0.996 |
| | 2 | 30-524 | 1.000 | 0.13 | 0.996 |
| | 3 | 31-529 | 0.981 | 2.21 | 0.997 |
| Palm | 1 | 30-530 | 1.006 | -2.33 | 0.995 |
| | 2 | 29-530 | 0.995 | 2.44 | 0.996 |
| | 3 | 30-533 | 0.994 | 3.34 | 0.994 |
| Forearm | 1 | 31-533 | 0.998 | -5.08 | 0.991 |
| | 2 | 29-526 | 0.989 | -1.13 | 0.994 |
| | 3 | 33-528 | 0.984 | -0.24 | 0.994 |

A usability study was conducted as follows:

To assess the performance of the Rightest GM 6500 Blood Glucose Monitoring System in the hands of the intended users, the sponsor performed a study with 161 lay user participants, who collected 161 each of fingerstick and palm samples and 157 forearm samples, at three study locations with three test strip lots. Health care professionals took one further measurement (immediately after) with the Rightest GM650 BGMS, and the results between the lay users and health care professionals

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were compared against YSI 2300.

# Professional and lay user test results of the fingertip vs YSI

| <75 mg/dL | Within ± 5 mg/dL | Within±10 mg/dL | Within±15 mg/dL | Within±20m g/dL |
| --- | --- | --- | --- | --- |
| Professional | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) |
| Lay User | 2/3 (66.7%) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) |
| ≥ 75 mg/dL | Within ±5 % | Within ±10 % | Within ±15 % | Within ±20 % |
| Professional | 91/158 (57.6%) | 142/158 (89.9%) | 157/158 (99.4%) | 158/158 (100%) |
| Lay User | 82/158 (51.9%) | 139/158 (88.0%) | 155/158 (98.1%) | 158/158 (100%) |

# Professional and lay user test results of the palm vs YSI

| <75 mg/dL | Within ± 5 mg/dL | Within±10 mg/dL | Within±15 mg/dL | Within±20m g/dL |
| --- | --- | --- | --- | --- |
| Professional | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) |
| Lay User | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) |
| ≥ 75 mg/dL | Within ±5 % | Within±10 % | Within±15 % | Within ±20 % |
| Professional | 100/158 (63.3%) | 145/158 (91.8%) | 158/158 (100%) | 158/158 (100%) |
| Lay User | 91/158 (57.6%) | 146/158 (92.4%) | 154/158 (97.5%) | 158/158 (100%) |

# Professional and lay user test results of the forearm vs YSI

| <75 mg/dL | Within ± 5 mg/dL | Within±10 mg/dL | Within±15 mg/dL | Within±20m g/dL |
| --- | --- | --- | --- | --- |
| Professional | 2/3 (66.7%) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) |
| Lay User | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) |
| ≥ 75 mg/dL | Within ±5 % | Within±10 % | Within±15 % | Within ±20 % |
| Professional | 80/154 (51.9%) | 127/154 (82.5%) | 150/154 (97.4%) | 154/154 (100%) |
| Lay User | 65/154 (42.2%) | 120/154 (77.9%) | 148/154 (96.1%) | 154/154 (100%) |

# Linear regression analysis for Lay User Vs YSI

| | Rightest GM650 fingertip vs YSI | Rightest GM650 palm vs YSI | Rightest GM650 forearm vs YSI |
| --- | --- | --- | --- |
| glucose range (mg/dL) | 72.2 ~ 371 | 72.2 ~ 371 | 72.2 ~ 371 |

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| N | 161 | 161 | 157 |
| --- | --- | --- | --- |
| Slope | 0.98 | 0.98 | 0.96 |
| Intercept | 0.76 | 1.51 | -0.22 |
| r | 0.98 | 0.98 | 0.97 |

# b. Matrix comparison:

This system is for use with fingerstick, palm, and forearm capillary samples. The meter's software adjusts the whole-blood glucose reading to a plasma-equivalent reading.

# 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):

# 4. Clinical cut-off:

Not applicable

# 5. Expected values/Reference range:

Expected glucose values for people without diabetes:

| Status | Range |
| --- | --- |
| Fasting | < 100 mg/dL |
| Two hrs after meal | < 140 mg/dL |

American Diabetes Association: Standard of Medical Care in Diabetes 2011, Diabetes Care, vol.34, supplement 1, S11-S61, January 2011.

# N. Instrument Name:

Rightest GM650 Blood Glucose Meter

GE Talking Blood Glucose Meter, Model GE300

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O. System Descriptions:

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 ☐ (or No ☑)

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?:
Yes ☐ or No ☑

2. Software:
FDA reviewed applicant’s Hazard Analysis and software development processes for this line of product types.:
Yes ☑ 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, palm, and forearm only. The whole blood sample is applied directly to the test strip by capillary action.

5. Calibration:
A single calibration code is programmed into the meters at the time of manufacturing and no user input is required for calibration.

6. Quality Control:
Three levels of aqueous glucose control solutions are available with this system. The meter has a function for the user to select the level of control solution they wish to run to prevent control results from being stored in the internal memory as patient results. 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 when the measurements are performed in the “CS measurement mode”. 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:

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1. **Hematocrit Study:**
A study to evaluate the effects of hematocrit was conducted on samples with 6 glucose concentrations (20-50, 60-80, 135-165, 180-220, 270-330 and 360-440 mg/dL) at 6 hematocrit levels (20, 25, 30, 40, 50, 60 and 65%). Each glucose level/hematocrit combination was tested in triplicate on 3 meters using 3 lots of test strips. Results of samples at each hematocrit level were compared to samples with the same glucose concentration at normal (45%) hematocrit as well as to the corresponding YSI value. Data provided for the claimed hematocrit range of 30-55% met the sponsor’s acceptance criteria of ±15%

2. **Altitude Study:**
A study was conducted to evaluate the effect of altitude on the GM650 BGMS. Test samples were tested on 3 meters in triplicate with 3 different strip vials using venous whole blood from healthy donors. Three glucose concentrations (ranging from 43.5-335 mg/dL) at three corresponding altitude levels (3280, 6561 and 9842 feet,) were tested in a controllable temperature/humidity chamber against a 0 meter level as a control. Each venous blood sample was also tested by the YSI 2300 analyzer. The meter readings obtained were compared to the YSI method and the percent bias was determined at each level against the YSI results. The sponsor showed the bias was within ±10% for all three altitude levels tested. Based on the data, the sponsor claims that the GM650 can be used up to 9842 feet

3. **Sample volume study:**
A sample volume study was performed to verify the minimum test strip sample volume requirement and the test strip fill error requirement established for the BGMS. Three lots of test strips were used to test spiked or glycolized venous whole blood at three glucose concentrations (40-60, 80-120 and 300-330 mg/dL). Blood at each of these concentrations was applied to strips at 6 target sample volumes of 0.6, 0.65, 0.75, 0.8, 1.0, and 1.25 μL. The sponsor concluded that sample volumes of ≥0.75 μL produced accurate results (the sponsor showed were within 8%), Samples &lt;0.75 μL gave an Er 4 error code. The labeling provides instructions and graphics to assist the user in obtaining and applying an adequate sample volume.

4. **User performance study:**
As part of the user performance study summarized in section M.2.a above, 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.

5. **Readability assessment:**
The Flesch-Kincaid readability assessment of the product labeling determined that the Owner’s Manuals and test strip inserts for both proposed devices were written at the 8th grade level.

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6. Temperature and humidity studies

Temperature and humidity studies were conducted that demonstrated that the devices can be used at temperatures from 6 to 40°C and at a relative humidity of 10 to 90%. The sponsor tested the extreme combinations of temperature and humidity and the results supported the claimed ranges.

7. Electromagnetic Compatibility:

EMC testing was performed/passed and a certificate granted to Bionime Inc. was provided.

8. Infection Control Studies:

The device is intended for single-patient use only. Discide Ultra disinfecting towelettes with EPA registration #10492-4 were validated demonstrating validation using hepatitis B surface antigen testing using materials from the meter and lancing device. The sponsor also demonstrated that there was no change in performance or in the external materials of the meters and lancing device after 550 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate 5 years of meter and lancing device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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.