Assure Titanium Blood Glucose Monitoring System

K200788 · Arkray, Inc. · PZI · May 23, 2022 · Clinical Chemistry

Device Facts

• Record ID: K200788
• Device Name: Assure Titanium Blood Glucose Monitoring System
• Applicant: Arkray, Inc.
• Product Code: PZI · Clinical Chemistry
• Decision Date: May 23, 2022
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing or skilled nursing facilities, for multiple patient use. This system should only be used with single-use, auto-disabling lancing devices for drawing finger stick capillary blood. The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The system is not intended for use in acute care or hospital settings. The system is not intended for neonatal use. The system is for prescription use only.

Device Story

System consists of battery-powered meter, disposable test strips, and control solutions; used in endocrinology clinics and nursing facilities by healthcare professionals. Input: fresh capillary whole blood via finger stick. Principle: amperometric biosensor; glucose oxidase (GOD) reacts with glucose in sample to produce electric current proportional to glucose concentration. Meter measures current, calculates glucose level, and displays result. Output: quantitative glucose concentration. Benefits: provides rapid point-of-care glucose monitoring for clinical decision-making in non-acute settings. Device includes test strip ejector and error flagging for out-of-range samples, short samples, or sample perturbation.

Clinical Evidence

Multi-center study (1 nursing facility, 2 endocrinology clinics) with 396 patients. Compared Assure Titanium results to YSI 2300 reference analyzer. Results showed strong linear correlation (r=0.99). Accuracy: 99.2% of samples ≥75 mg/dL within ±15% of reference; 100% of samples <75 mg/dL within ±15 mg/dL. Bench testing confirmed precision (%CV ≤4.2%), linearity (10-600 mg/dL), hematocrit range (10-70%), and interference resistance.

Technological Characteristics

Amperometric electrochemical biosensor; glucose oxidase enzyme; hexaammineruthenium (III) chloride mediator; battery-powered meter; capillary action sample intake; 0.5 μL sample volume; 7-second measurement time; 10-600 mg/dL measuring range; automated calibration; 10-70% hematocrit range; compliant with IEC 60601-1-2 for EMC.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from fingertips in endocrinology clinics and nursing/skilled nursing facilities. For prescription, point-of-care, multiple-patient use. Not for diabetes screening/diagnosis, acute care, hospital settings, or neonatal use. Contraindicated for patients undergoing tight glycemic control or those with severe hypotension, shock, hyperosmolar-hyperglycemia, or severe dehydration.

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

• Statstrip Glucose Hospital Meter System (k132121)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K200788

B Applicant

Arkray, Inc.

C Proprietary and Established Names

Assure Titanium Blood Glucose Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PZI | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) for a new device, tracked as k200788 and CW200005.

B Measurand:

Glucose in fresh capillary whole blood drawn from the fingertips

C Type of Test:

Quantitative amperometric assay (glucose oxidase)

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

K200788 - Page 2 of 29

## III Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) for Use:

The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing or skilled nursing facilities, for multiple patient use. This system should only be used with single-use, auto-disabling lancing devices for drawing finger stick capillary blood.

The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The system is not intended for use in acute care or hospital settings.

The system is not intended for neonatal use.

The system is for prescription use only.

### C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

For point-of-care use only.

In vitro diagnostic use.

Not for Alternative Site Testing (AST).

Do not use the Assure Titanium Blood Glucose Monitoring System for screening or diagnosis of diabetes.

Not indicated for use in patients undergoing tight glycemic control.

Do not use the Assure Titanium Blood Glucose Monitoring System to test neonates. The Assure Titanium Blood Glucose Monitoring System has not been validated for neonatal use.

Do not use at altitudes higher than 10,000 ft (3048 m) above sea level.

Use only Assure Titanium Blood Glucose Test Strips for testing with the Assure Titanium Blood Glucose Meter.

Assure Titanium device should not be used in patients receiving intensive medical intervention/ therapy because of the potential for pre-analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state when test results are generated using capillary whole blood samples. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration.

{2}

D Special Instrument Requirements:

Assure Titanium Blood Glucose Meter

IV Device/System Characteristics:

A Device Description:

The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately. The candidate test strips were previously cleared in k170064 as part of the GLUCOCARD W Blood Glucose Monitoring System.

B Principle of Operation:

The Assure Titanium Blood Glucose Monitoring System measures the amount of glucose in capillary whole blood from the fingertip quantitatively, using amperometric technology. The test is based on the measurement of the electric current generated by the reaction of the capillary whole blood glucose with glucose oxidase (GOD) and a mediator on the test strip (hexaammineruthenium (III) chloride). The magnitude of the resultant current is proportional to the glucose concentration in the sample. The detected current signal is then calculated by the meter and glucose concentration reading is then displayed on the meter.

Instrument Description Information:

1. Instrument Name:

Assure Titanium Blood Glucose Meter

2. Specimen Identification:

There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.

3. Specimen Sampling and Handling:

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

4. Calibration:

The meter does not require calibration or coding by the user. The detection of the calibration code is automatic.

K200788 - Page 3 of 29

{3}

K200788 - Page 4 of 29

5. Quality Control:

The Assure Control - Control Solutions are aqueous solutions available at three different glucose levels (Level 1: 40 mg/L ± 11% glucose, Level 2: 130 mg/L ± 11% glucose, and Level 3: 360 mg/dL ± 11% glucose). Instructions on how to order control solutions, and when to perform a control solution test are included in the labeling. The acceptable range for each control level is printed on the test strip bottle or on the bottom of the test strip box. The meter automatically recognizes and flags the test result in the memory as a control solution test result. The user is cautioned not to use the meter and to contact the customer support if the control result falls outside the ranges printed on the test strip vial label.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Statstrip Glucose Hospital Meter System

B Predicate 510(k) Number(s):

k132121

C Comparison with Predicate(s):

| Device & Predicate Device(s): | k200788 | k132121 |
| --- | --- | --- |
| Device Trade Name | Assure Titanium Blood Glucose Monitoring System | Statstrip Glucose Hospital Meter System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care, multiple patient use in endocrinology clinics and nursing or skilled nursing facilities, as an aid to measure glucose in the blood. | Quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital |

{4}

| Device & Predicate Device(s): | k200788 | k132121 |
| --- | --- | --- |
| | | and all professional healthcare settings. |
| Test Principle | Electro-chemical biosensor (Amperometric) | Same |
| Enzyme | Glucose oxidase | Same |
| Measuring Range | 10-600 mg/dL | Same |
| Calibration | Automated coded calibration | Same |
| General Device Characteristic Differences | | |
| Sample Type | Fresh capillary whole blood | Whole Blood: Capillary, Venous, Arterial, and Neonate arterial whole blood |
| Test Strip Ejector | Yes | No |
| Controls | 2 levels of Assure Control Solutions | 3 levels of Nova StatStrip Control Solutions |
| Sample Volume | 0.5 μL | 1.2 μL |
| Operating Conditions | 46-104 °F (8-40 °C) / 10-90% RH | 59-104 °F (15-40 °C) / 10-90% RH |
| Hematocrit Range | 10-70 % | 20-65 % |
| Measuring Time | 7 seconds | 6 seconds |

VI Standards/Guidance Documents Referenced:

IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests.

CLSI EP06-A: 2003, Evaluation of the linearity of quantitative analytical Methods: A Statistical Approach.

CLSI EP07-A2: 2005, Interference Testing in Clinical Chemistry, Approved Guideline, 2nd Edition.

CLSI EP25-A: 2009, Evaluation of stability of in vitro diagnostic reagents.

K200788 - Page 5 of 29

{5}

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Within-run and intermediate precision for the Assure Titanium Blood Glucose Monitoring System were evaluated to assess imprecision of the system across the glucose measuring range and under normal use conditions.

Within-run precision was evaluated using venous whole blood spiked with high concentration glucose solution or allowed to glycolyze to achieve 5 glucose concentrations (30-50, 51-110, 111-150, 151-250 and 250-400 mg/dL). Each level was tested with three lots of test strips in replicates of 10 on each of 10 meters for a total of 300 results per glucose concentration and 1500 results total. Results for the within-run precision testing are summarized in the table below.

| Glucose Level (mg/dL) | Lot | N | Mean (mg/dL) | SD (mg/dL) | %CV |
| --- | --- | --- | --- | --- | --- |
| 30-50 | 1 | 100 | 45.7 | 1.2 | 2.6% |
| | 2 | 100 | 44.4 | 1.3 | 2.9% |
| | 3 | 100 | 42.6 | 1.0 | 2.4% |
| | Combined | 300 | 44.2 | 1.7 | 3.9% |
| 51-110 | 1 | 100 | 96.3 | 2.0 | 2.1% |
| | 2 | 100 | 95.7 | 2.0 | 2.1% |
| | 3 | 100 | 92.8 | 2.3 | 2.4% |
| | Combined | 300 | 94.9 | 2.6 | 2.7% |
| 111-150 | 1 | 100 | 140.2 | 3.1 | 2.2% |
| | 2 | 100 | 137.8 | 2.8 | 2.0% |
| | 3 | 100 | 139.6 | 3.2 | 2.3% |
| | Combined | 300 | 139.2 | 3.2 | 2.3% |
| 151-250 | 1 | 100 | 203.7 | 6.2 | 3.1% |
| | 2 | 100 | 202.7 | 3.8 | 1.9% |
| | 3 | 100 | 204.9 | 4.9 | 2.4% |
| | Combined | 300 | 203.8 | 5.1 | 2.5% |
| 251-400 | 1 | 100 | 324.3 | 10.1 | 3.1% |
| | 2 | 100 | 324.2 | 7.5 | 2.3% |
| | 3 | 100 | 324.1 | 8.7 | 2.7% |
| | Combined | 300 | 342.2 | 8.8 | 2.7% |

K200788 - Page 6 of 29

{6}

Intermediate precision was evaluated using 5 control solutions at glucose levels within the ranges of 30-50, 51-100, 111-150, 151-250, and 251-400 mg/dL. Multiple operators tested the control solutions over 10 days using 3 lots of test strips and 10 meters, conducting one measurement per meter per day at the different glucose ranges. This resulted in 50 tests per lot per day for a total of 1500 tests. Results for intermediate precision testing are summarized in the table below.

| Glucose Level (mg/dL) | Lot | N | Mean (mg/dL) | SD (mg/dL) | %CV |
| --- | --- | --- | --- | --- | --- |
| 30-50 | 1 | 100 | 42.8 | 0.8 | 1.9 |
| | 2 | 100 | 42.4 | 0.7 | 1.6 |
| | 3 | 100 | 42.0 | 0.6 | 1.5 |
| | Combined | 300 | 42.4 | 0.8 | 1.9 |
| 51-110 | 1 | 100 | 87.3 | 1.4 | 1.6 |
| | 2 | 100 | 87.4 | 1.1 | 1.2 |
| | 3 | 100 | 86.2 | 1.4 | 1.7 |
| | Combined | 300 | 87.0 | 1.4 | 1.6 |
| 111-150 | 1 | 100 | 129.8 | 1.7 | 1.3 |
| | 2 | 100 | 129.7 | 1.4 | 1.1 |
| | 3 | 100 | 128.5 | 1.8 | 1.4 |
| | Combined | 300 | 129.3 | 1.8 | 1.4 |
| 151-250 | 1 | 100 | 256.6 | 3.2 | 1.3 |
| | 2 | 100 | 255.8 | 3.3 | 1.3 |
| | 3 | 100 | 251.8 | 3.5 | 1.4 |
| | Combined | 300 | 254.7 | 3.9 | 1.5 |
| 251-400 | 1 | 100 | 363.9 | 5.3 | 1.5 |
| | 2 | 100 | 364.6 | 5.6 | 1.5 |
| | 3 | 100 | 353.4 | 5.5 | 1.6 |
| | Combined | 300 | 360.6 | 7.5 | 2.1 |

2. Linearity:

Linearity of the Assure Titanium Blood Glucose Monitoring System was evaluated using venous whole blood spiked with high concentration glucose solution or allowed to glycolyze to achieve 11 glucose concentrations (6.3, 31.2, 46.9, 68.9, 135.0, 197.0, 254.5, 351.9, 421.0, 493.5 and 613.3 mg/dL). The target glucose concentrations were verified by the comparator method (YSI 2300 STAT Plus analyzer). Results on the candidate device were compared to results on the comparator. Each glucose level was tested using 3 test strip lots and 5 meters, for a total of 15 replicates per level and a total of 165 results.

K200788 - Page 7 of 29

{7}

Linear regression data analysis, with regression equation and coefficient of determination $(\mathbb{R}^2)$ presented for each lot tested is summarized in the table below:

| Lot | Linear Regression Equation | R2 |
| --- | --- | --- |
| 1 | y = 1.0079x + 3.9485 | 0.9988 |
| 2 | y = 1.0063x + 3.3727 | 0.9993 |
| 3 | y = 0.9902x + 2.1839 | 0.9999 |

The results of the study support linearity of the Assure Titanium Blood Glucose Monitoring System across the claimed measuring range of $10 - 600\mathrm{mg / dL}$ . If the concentration of a sample is less than $10\mathrm{mg / dL}$ glucose, the result is flagged by the meter as "Lo". If a sample exceeds $600\mathrm{mg / dL}$ glucose, the result is flagged by the meter as "Hi". The "Lo" and "Hi" functions were validated and demonstrated to function as intended.

# 3. Analytical Specificity/Interference:

Interference testing was conducted to evaluate the effect of common endogenous substances and exogenous substances expected in the intended use population on the Assure Titanium Blood Glucose Monitoring System. Additional potential interferents were included in the testing following a detailed analysis of medications and medical conditions of the subjects evaluated in the method comparison study (please see the tables in Section VII.B.1 below for a detailed list of medications and conditions). The study was designed using whole blood samples spiked or allowed to glycolyze to 3 target glucose levels (50-70 mg/dL, 110-130 mg/dL, and 225-270 mg/dL). Samples were divided into a test pool with the potential interferent added and a control sample with no added interferent. Each interferent was tested at clinically relevant concentrations.

Results on the candidate meter from the test samples were compared to results obtained on the candidate meter from the control sample. If interference was observed, additional testing was performed to determine the concentration at which the interference starts to occur. Potentially interfering substances, the maximum concentrations tested and the highest tested concentration at which no significant interference (defined by the sponsor as average % bias $\leq 10\%$ ) was observed are listed in the table below:

| Potential Interfering Substance | Highest Concentration with no Significant Interference |
| --- | --- |
| Acetaminophen | 20 mg/dL |
| Ascorbic acid | 4 mg/dL |
| Conjugated Bilirubin | 50 mg/dL |
| Unconjugated Bilirubin | 40 mg/dL |
| Cholesterol | 500 mg/dL |
| Creatinine | 15 mg/dL |
| Dopamine | 20 mg/dL |
| EDTA | 180 mg/dL |
| Galactose | 60 mg/dL |

K200788 - Page 8 of 29

{8}

K200788 - Page 9 of 29
| Potential Interfering Substance | Highest Concentration with no Significant Interference |
| --- | --- |
| Gentisic acid | 700 mg/dL |
| Reduced Glutathione | 92 mg/dL |
| Hemoglobin | 20,000 mg/dL |
| Heparin | 500 IU/dL |
| Ibuprofen | 50 mg/dL |
| Icodextrin | 1094.4 mg/dL |
| L-Dopa | 0.75 mg/dL |
| Maltose | 5,000 mg/dL |
| Methyl-L-dopa | 1000 mg/dL |
| Salicylic acid | 60 mg/dL |
| Sodium | 414 mmol/L |
| Tolbutamide | 100 mg/dL |
| Tolazamide | 40 mg/dL |
| Triglycerides | 1,500 mg/dL |
| Uric acid | 24 mg/dL |
| Xylose | 300 mg/dL |
| Xylitol | 0.09 mg/dL |
| Mannitol | 1,800 mg/dL |
| Fenofibric Acid | 18 mg/dL |
| Canagliflozin | 15 x 10^{-4} mg/dL |
| Amlodipine Besylate | 18 x 10^{-4} mg/dL |
| Atorvastatin Calcium | 84 x 10^{-4} mg/dL |
| Cilostazol | 21 x 10^{-2} mg/dL |
| Prasugrel | 105 x 10^{-3} mg/dL |
| Nortriptyline HCl | 45 x 10^{-6} mg/dL |
| Budesonide | 36 x 10^{-5} mg/dL |
| Dextromethorphan | 9 x 10^{-4} mg/dL |
| Oxcarbazepine | 258 x 10^{-2} mg/dL |
| Trihexyphenidyl HCL | 15 x 10^{-3} mg/dL |
| Fluphenazine Decanoate | 81 x 10^{-5} mg/dL |
| Levoflaxicin | 183 x 10^{-5} mg/dL |
| Glimiperide | 576 x 10^{-4} mg/dL |
| Benazeprilat | 297 nmol/dL |
| Saxagliptin | 72 x 10^{-4} mg/dL |
| Morphine | 28.3 nmol/dL |
| Ursodiol | 7,836 x 10^{-4} mg/dL |

{9}

| Potential Interfering Substance | Highest Concentration with no Significant Interference |
| --- | --- |
| Silodosin | 1848 x 10^{-5} mg/dL |
| Letrozole | 31.2 nmol/dL |

The following limitations are included in the user manual and test strip package insert:
- Patients with high doses of Vitamin C intake (ascorbic acid; blood levels higher than 4 mg/dL) may yield inaccurate results.
- Patients undergoing oxygen therapy may yield inaccurate results.

4. Assay Reportable Range:

The reportable range is 10 - 600 mg/dL.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

The Assure Titanium Blood Glucose Monitoring System is traceable to the NIST (SRM) 917c glucose reference material. A method comparison was performed using the candidate device and YSI 2300 STAT Plus as the comparator method (see section VII.A.3 below).

Test Strip Stability

Shelf-life and open vial stability protocols and acceptance criteria for the Assure Titanium Blood Glucose Test Strips were previously evaluated in k170064 and were found to support the claimed shelf-life of 24 months and open vial stability of 6 months when stored at 34-86°F (1-30°C) and 10-90% relative humidity.

6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

Not applicable.

8. Accuracy (Instrument):

Not applicable.

9. Carry-Over:

Not applicable.

K200788 - Page 10 of 29

{10}

B Comparison Studies:

1. Method Comparison with Predicate Device:

The performance of the Assure Titanium Blood Glucose Monitoring System was established in the intended use environment using capillary fingerstick samples from 396 patients at three clinical sites covering the two intended use settings (one nursing and skilled nursing facility and two endocrinology clinics) across the United States using untrained intended use operators (point-of-care operators). Site 1 was a 475-bed nursing and skilled nursing site. The study took place across both the long-term care nursing and rehabilitation unit (also known as a temporary care unit). Sites 2 and 3 were endocrinology clinics.

All testing with the Assure Titanium Blood Glucose Meter was performed by CLIA waived operators (non-laboratory personnel, e.g., registered nurses/licensed practical nurses, medical aides, office manager, receptionist).

The glucose levels tested ranged from 29.0 to 492.5 mg/L, with 32 results falling below 80 mg/dL and 22 results falling above 300 mg/dL. The hematocrit and sodium levels for all subjects tested were recorded. Testing was performed on six lots of Assure Titanium test strips using 26 Assure Titanium meters. The clinical study included subjects with reported 390 unique patient medical conditions receiving a total of 4066 unique medications, that accounted for 379 drugs classified by generic name, representing 14 main drug classes including nervous system, cardiovascular system, and alimentary tract and metabolism drug classes.

The Assure Titanium Blood Glucose Monitoring System results were compared to the YSI 2300 STAT Plus as the comparator method. The results were calculated separately for each type of clinical site as well as all sites combined.

| Site | Site Type | Number of Patients | Glucose Range (mg/dL) | Hematocrit (%) |
| --- | --- | --- | --- | --- |
| 1 | Nursing and skilled nursing facility | 130 | 29.0-405.5 | 19-44 |
| 2 | Endocrinology Clinic | 165 | 43.7-492.5 | 25-51 |
| 3 | Endocrinology Clinic | 101 | 49.3-367.8 | 30-54 |

The results from the capillary fingerstick samples obtained from the Assure Titanium Blood Glucose Meter compared to the results from the comparator method, per site type, as well as all sites combined are summarized below:

K200788 - Page 11 of 29

{11}

Results for Glucose Concentrations &lt;75 mg/dL:

| Site | Within ±5 mg/dL | Within ±10 mg/dL | Within ±12 mg/dL | Within ±15 mg/dL |
| --- | --- | --- | --- | --- |
| 1 | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| 2 and 3 | 17/26 (65.4%) | 25/26 (96.2%) | 26/26 (100%) | 26/26 (100%) |
| All sites combined | 18/27 (66.7%) | 26/27 (96.3%) | 27/27 (100%) | 27/27 (100%) |

Results for Glucose Concentrations ≥75 mg/dL:

| Site | Within ± 5% | Within ± 10% | Within ± 12% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- | --- | --- |
| 1 | 80/129 (62.0%) | 122/129 (94.6%) | 125/129 (96.9%) | 128/129 (99.2%) | 129/129 (100%) |
| 2+3 | 163/240 (67.9%) | 224/240 (93.3%) | 230/240 (95.8%) | 235/240 (97.9%) | 240/240 (100%) |
| All sites combined | 243/369 (65.9%) | 346/369 (93.8%) | 355/369 (96.2%) | 363/369 (98.4%) | 369/369 (100%) |

The sponsor also conducted a usability study of the Assure Titanium Blood Glucose Monitoring System. The 10 point-of-care operators who participated in the study filled out two questionnaires: one concerning the ease of the use of the blood glucose system and one concerning the ease of understanding of the user manual and QRG. The results demonstrated that the participants were able to understand the labeling and conduct the testing on their own.

A readability assessment using SMOG analysis was conducted, and the results demonstrate that the of the user manual and quick reference guide (QRG) were written at a 7.4 and 7.2 grade level, respectively.

## Patient Conditions:

The 396 study participants fell into the following medical condition categories that included over 415 unique patient medical conditions, as described in the table below:

| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| Auditory | Excessive Cerumen | 3 |
| | Hard of Hearing | 19 |
| | Ruptured Eardrum | 1 |
| Biliary | Cholangitis | 3 |
| | Cholecystectomy | 3 |
| | Cholecystitis | 1 |
| | Cholelithiasis | 2 |
| Cancer | Benign Neoplasm | 1 |
| | Bone Cancer | 1 |
| | Brain Cancer | 1 |

K200788 - Page 12 of 29

{12}

| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| Cardiac | Breast Cancer | 8 |
| | Breast Cancer, Historical | 4 |
| | Colon Cancer | 1 |
| | Colon Cancer, Historical | 2 |
| | Hepatocellular Carcinoma | 1 |
| | Leukemia | 1 |
| | Lipoma | 2 |
| | Liver Cancer | 1 |
| | Lung Cancer | 2 |
| | Lymphatic Cancer | 1 |
| | Meningioma | 2 |
| | Multiple Myeloma | 1 |
| | Non-Hodgkin's Lymphoma | 1 |
| | Pancreatic Cancer | 1 |
| | Prostate Cancer | 6 |
| | Renal Cancer | 4 |
| | Renal Cancer, Historical | 1 |
| | Skin Cancer | 4 |
| | Skin Cancer, Historical | 3 |
| | Throat Cancer | 1 |
| | Thyroid Cancer | 2 |
| | Thyroid Cancer, Historical | 1 |
| Cardiac | Aortic Aneurysm | 3 |
| | Aortic Insufficiency | 1 |
| | Aortic Regurgitation | 1 |
| | Aortic Stenosis | 9 |
| | Arrhythmia | 2 |
| | Arteriosclerosis | 2 |
| | Atrial Fibrillation | 32 |
| | Bradycardia | 5 |
| | Bundle Branch Block | 3 |
| | Cardiovascular Disease | 3 |
| | Carotid Artery Occlusion | 1 |
| | Chest Pain | 1 |
| | Chronic Systolic Heart Failure | 1 |
| | Coronary Artery Disease | 36 |
| | Elevated Troponin | 2 |
| | Endocarditis | 2 |
| | Heart Block | 2 |
| | Heart Disease | 7 |
| | Heart Failure | 41 |
| | Heart Murmur | 3 |
| | Hypertension | 248 |
| | Hypotension | 4 |
| Mitral Insufficiency | 1 | |

K200788 - Page 13 of 29

{13}

K200788 - Page 14 of 29
| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| | Mitral Regurgitation | 2 |
| | Mitral Stenosis | 1 |
| | Mitral Valve Prolapse | 2 |
| | Myocardial Infarction | 3 |
| | Myocarditis | 1 |
| | Occlusion and Stenosis of Carotid Artery | 1 |
| | Palpitations | 2 |
| | Patent Foramen Ovale | 2 |
| | Premature Atrial Contraction | 1 |
| | Premature Ventricular Contractions | 1 |
| | Sick Sinus Syndrome | 1 |
| | Sinus Node Dysfunction | 1 |
| | Sleep Apnea | 19 |
| | Tachycardia | 4 |
| | Tricuspid Regurgitation | 1 |
| | Ventricular Arrhythmia | 1 |
| | Ventricular Outflow Obstruction | 1 |
| Dermatological | Abscess | 3 |
| | Asteototic Dermatitis | 1 |
| | Blepharitis | 2 |
| | Dermatitis | 7 |
| | Eczema | 4 |
| | Erythema | 1 |
| | Foot Complications | 39 |
| | Intertrigo | 3 |
| | Pruritic Disorder | 1 |
| | Pruritus | 5 |
| | Psoriasis | 2 |
| | Rosacea | 2 |
| | Seborrheic Dermatitis | 3 |
| | Seborrheic Keratosis | 4 |
| | Skin Complications | 21 |
| | Skin Infection | 3 |
| | Skin Ulcer | 29 |
| | Tinea Pedis | 3 |
| | Tinea Versicolor | 1 |
| Endocrine | Adrenal Insufficiency | 1 |
| | Adrenal Nodule | 1 |
| | Gynecomastia | 1 |
| Gastro-Intestinal | Acid Reflux | 1 |
| | Celiac Disease | 1 |
| | Colitis | 2 |
| | Colon Polyp | 2 |

{14}

K200788 - Page 15 of 29
| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| | Constipation | 68 |
| Diarrhea | 15 |
| Diverticulitis | 1 |
| Diverticulosis | 1 |
| Gastroenteritis | 1 |
| Gastroesophageal Reflux Disease | 51 |
| Gastrointestinal Hemorrhage | 2 |
| Gastrointestinal Problems | 34 |
| Heartburn | 1 |
| Incontinence | 26 |
| Indigestion | 2 |
| Irritable Bowel Syndrome | 4 |
| Irritable Colon | 1 |
| Ischemic Colitis | 1 |
| Malabsorption Syndrome | 1 |
| Nausea | 6 |
| Pancreatitis | 2 |
| Peptic Ulcer | 3 |
| Rectal Prolapse | 1 |
| Ulcer | 1 |
| Vomiting | 5 |
| Hepatic | Bilirubinemia | 1 |
| Cirrhosis | 1 |
| Elevated INR | 1 |
| Fatty Liver | 2 |
| Hepatitis | 1 |
| Hyperbilirubinemia | 2 |
| Liver Dysfunction | 8 |
| Subtherapeutic INR | 2 |
| Supratherapeutic INR | 1 |
| Transaminitis | 1 |
| Hypoalbuminemia | 1 |
| Hormonal | Hyperprolactinemia | 1 |
| Hypogonadism | 3 |
| Polycystic Ovarian Syndrome | 2 |
| Immune | Arthritis | 12 |
| Bacteremia | 1 |
| Bacterial Infection | 3 |
| Candida Infection | 3 |
| Cellulitis | 2 |
| Cold Sores | 1 |
| Crohn's | 1 |
| Eosinophilia | 1 |
| Fever | 7 |

{15}

K200788 - Page 16 of 29
| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| | Gout | 19 |
| | Herpes Zoster | 1 |
| | Idiopathic Thrombocytopenic Purpura | 1 |
| | Immunodeficiency | 1 |
| | Immunosuppression | 1 |
| | Joint Inflammation | 1 |
| | Leukocytosis | 16 |
| | Leukopenia | 1 |
| | Lichen Planus | 1 |
| | Lymphadenitis | 1 |
| | Lymphedema | 1 |
| | Myasthenia Gravis | 2 |
| | Myelodysplastic Syndrome | 1 |
| | Oligoarthritis | 1 |
| | Onychomycosis | 3 |
| | Paronychia | 1 |
| | Photosensitivity | 1 |
| | Plantar Fasciitis | 1 |
| | Polymyalgia Rheumatica | 2 |
| | Rheumatoid Arthritis | 10 |
| | Sepsis | 2 |
| | Septic Arthritis | 1 |
| | Sjogrens Syndrome | 1 |
| | Verruca | 1 |
| Lipid Disorder | Dyslipidemia | 11 |
| | Hyperlipidemia | 126 |
| Metabolic | Diabetic Ketoacidosis | 1 |
| | Gestational Diabetes | 1 |
| | Hemochromatosis | 1 |
| | Hereditary Coproporphyria | 1 |
| | Hypercalcemia | 4 |
| | Hypercholesteremia | 2 |
| | Hypercholesterolemia | 1 |
| | Hyperglycemia | 2 |
| | Hyperkalemia | 6 |
| | Hypernatremia | 3 |
| | Hyperuricemia | 1 |
| | Hypocalcemia | 1 |
| | Hypoglycemia | 5 |
| | Hypokalemia | 16 |
| | Hypomagnesemia | 6 |
| | Hyponatremia | 13 |
| | Malnutrition | 15 |
| | Microalbuminuria | 1 |
| | Obesity | 12 |

{16}

K200788 - Page 17 of 29
| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| | Tumoral Calcinosis | 1 |
| Vitamin Deficiency | 42 |
| Weight Gain | 5 |
| Weight Loss | 19 |
| Musculoskeletal | Achalasia | 1 |
| Bursitis | 3 |
| Cervical Spondylosis | 3 |
| Contracture | 1 |
| Degenerative Disc Disease | 2 |
| Degenerative Spondylolisthesis | 1 |
| Dysarthria | 2 |
| Dystonia | 1 |
| Esophageal Dysmotility | 1 |
| Hernia | 7 |
| Kyphosis | 2 |
| Leg Cramp | 1 |
| Monoclonal Gammopathy of Unknown Significance | 2 |
| Muscle Spasms | 2 |
| Muscle Weakness | 8 |
| Muscular Dystrophy | 1 |
| Myalgia | 1 |
| Myositis | 1 |
| Osteoarthritis | 37 |
| Osteomyelitis | 6 |
| Osteopenia | 3 |
| Osteoporosis | 24 |
| Pancytopenia | 3 |
| Polyarthralgia | 2 |
| Scoliosis | 2 |
| Spinal Stenosis | 16 |
| Temporomandibular Joint Syndrome | 1 |
| Tendinitis | 2 |
| Neurological | Agitation | 2 |
| Alzheimer's | 14 |
| Amnesia | 1 |
| Anorexia | 4 |
| Anxiety | 27 |
| Autonomic Neuropathy | 1 |
| Bipolar Disorder | 2 |
| Carpal Tunnel | 3 |
| Cervical Radiculopathy | 1 |
| Cervicalgia | 1 |
| Chronic Hypomanic | 1 |

{17}

K200788 - Page 18 of 29
| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| | Chronic Pain | 60 |
| | Claustrophobia | 1 |
| | Cognitive Impairment | 30 |
| | Concussion | 1 |
| | Cord Compression | 1 |
| | Delirium | 13 |
| | Delusions | 2 |
| | Dementia | 33 |
| | Depression | 45 |
| | Diplegia | 1 |
| | Dizziness | 6 |
| | Dysautonomia | 1 |
| | Dysphagia | 27 |
| | Dysphonia | 1 |
| | Dysthymia | 1 |
| | Encephalopathy | 12 |
| | Essential Tremor | 2 |
| | Excoriation | 1 |
| | Fibromyalgia | 2 |
| | Globus Sensation | 1 |
| | Hallucinations | 2 |
| | Headache | 1 |
| | Lumbar Radiculopathy | 2 |
| | Memory Issues | 2 |
| | Migraine | 2 |
| | Mood Disorder | 1 |
| | Motor Skill Impairment | 11 |
| | Myoclonus | 1 |
| | Narcolepsy | 1 |
| | Neuralgia | 2 |
| | Neurologic Neglect Syndrome | 1 |
| | Neuropathy | 98 |
| | Nicotine Addiction | 1 |
| | Obsessive Compulsive Disorder | 1 |
| | Orthostatic Hypertension | 1 |
| | Orthostatic Hypotension | 11 |
| | Palsy | 1 |
| | Panic Attacks | 1 |
| | Parkinson's | 7 |
| | Polyneuropathy | 4 |
| | Post-Traumatic Stress Disorder | 1 |
| Postural Orthostatic Tachycardia Syndrome | 1 | |

{18}

K200788 - Page 19 of 29
| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| | Radicular Syndrome | 1 |
| | Schizophrenia | 1 |
| | Sciatica | 2 |
| | Seizures | 4 |
| | Somnolence | 1 |
| | Syrinx of Spinal Cord | 1 |
| | Tardive Dyskinesia | 1 |
| | Tremor | 1 |
| | Vascular Dementia | 3 |
| | Vasovagal Syncope | 1 |
| | Vertigo | 4 |
| Ocular | Blindness | 10 |
| | Bullous Keratopathy | 1 |
| | Cataract | 15 |
| | Conjunctivitis | 4 |
| | Dry Eye | 7 |
| | Glaucoma | 22 |
| | Macular Degeneration | 6 |
| | Macular Edema | 1 |
| | Pseudophakia | 2 |
| | Retinopathy | 1 |
| | Vision Problems | 78 |
| | Visual Impairment | 1 |
| Oral | Dental Abscess | 1 |
| | Gingival Bleeding | 1 |
| | Xerostomia | 4 |
| Other | Abnormal Gait | 26 |
| | Apathy | 1 |
| | Ascites | 1 |
| | Balance Issues | 45 |
| | Debility | 55 |
| | Dehydration | 3 |
| | Fatigue | 3 |
| | Frailty Syndrome | 4 |
| | Hyperproteinemia | 1 |
| | Hypothermia | 1 |
| | Impaired Mobility | 1 |
| | Insomnia | 53 |
| | Lethargy | 4 |
| | Mobility Issues | 1 |
| | Organ Prolapse | 3 |
| | Overweight | 1 |
| | Polypharmacy | 6 |
| | Polytrauma | 1 |
| | Sequela | 1 |

{19}

K200788 - Page 20 of 29
| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| Pancreatic | Intraductal Papillary Mucinous Neoplasm | 1 |
| Renal | Acute Kidney Disease | 28 |
| | Chronic Kidney Disease | 54 |
| | Diabetes Insipidus | 1 |
| | Elevated Alkaline Phosphatase | 1 |
| | Elevated Uric Acid | 1 |
| | Hematuria | 7 |
| | Hepatorenal Syndrome | 1 |
| | Hyperosmolality | 1 |
| | Interstitial Nephritis | 1 |
| | Kidney Disease | 49 |
| | Nephrolithiasis | 1 |
| | Nephropathy | 1 |
| | Renal Mass | 1 |
| | Tubulointerstitial Disease | 1 |
| Reproductive | Benign Prostatic Hyperplasia | 17 |
| | Endometriosis | 1 |
| | Enlarged Prostate | 2 |
| | Impotence | 25 |
| | Prostatitis | 1 |
| Respiratory | Allergic Rhinitis | 6 |
| | Asthma | 12 |
| | Bronchiectasis | 2 |
| | Bronchitis | 1 |
| | Chronic Obstructive Pulmonary Disease | 10 |
| | Cough | 17 |
| | Dyspnea | 2 |
| | Hypercarbia | 2 |
| | Lung Disease | 1 |
| | Pickwickian Syndrome | 1 |
| | Pleural Effusion | 2 |
| | Pneumonia | 13 |
| | Pneumonitis | 1 |
| | Pulmonary Edema | 5 |
| | Pulmonary Embolism | 1 |
| | Pulmonary Fibrosis | 1 |
| | Pulmonary Infection | 1 |
| | Pulmonary Mycobacterial Infection | 1 |
| | Pulmonary Nodules | 2 |
| | Respiratory Failure | 9 |
| | Restrictive Lung Disease | 1 |
| | Shortness of Breath | 1 |

{20}

| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| | Sinusitis | 2 |
| | Upper Respiratory Infection | 1 |
| Thyroid | Diaphoresis | 1 |
| | Goiter | 6 |
| | Hashimoto's | 4 |
| | Hyperparathyroidism | 4 |
| | Hyperthyroidism | 5 |
| | Hypoparathyroidism | 1 |
| | Hypothyroidism | 60 |
| | Thyroid Disorder | 2 |
| | Thyroid Nodule | 5 |
| Urinary | Bacteriuria | 1 |
| | Bladder Diverticulus | 1 |
| | Cystitis | 1 |
| | Dysuria | 6 |
| | Frequent Urination | 3 |
| | Overactive Bladder | 6 |
| | Urinary Retention | 15 |
| | Urinary Tract Infection | 25 |
| Vascular | Anemia | 65 |
| | Aneurysm | 4 |
| | Arterial Embolism | 1 |
| | Artery Stenosis | 2 |
| | Atherosclerosis | 3 |
| | Cerebral Artery Syndrome | 1 |
| | Cerebral Microvascular Disease | 1 |
| | Cerebral Vascular Accident | 9 |
| | Cerebrovascular Disease | 3 |
| | Coagulopathy | 2 |
| | Contusion | 3 |
| | Deep Vein Thrombosis | 3 |
| | Edema | 33 |
| | Epistaxis | 1 |
| | Gangrene | 2 |
| | Hematoma | 4 |
| | Hemorrhage | 6 |
| | Hemorrhoids | 11 |
| | Hypocapnia | 1 |
| | Hypoxemia | 6 |
| | Hypoxia | 6 |
| | Ischemia | 1 |
| | Methemoglobinemia | 1 |
| | Peripheral Vascular Disease | 17 |
| Pulmonary Vascular Congestion | 1 | |

K200788 - Page 21 of 29

{21}

| Condition Category | Medical Condition | Number of Patients |
| --- | --- | --- |
| | Purpura | 2 |
| | Stroke | 30 |
| | Swelling | 3 |
| | Syncope | 1 |
| | Thalassemia | 1 |
| | Thrombocytopenia | 14 |
| | Thrombocytosis | 4 |
| | Thrombosis | 1 |
| | Transient Ischemic Attack | 3 |
| | Varicose Veins | 1 |
| | Venous Insufficiency | 5 |
| | Venous Ulcer | 2 |

## Medications:

During the study, participants received a total of 4066 unique medications, that accounted for 379 drugs classified by generic name, representing multiple drug classes, as described in the table below:

| Therapeutic Drug Class 2 | Therapeutic Drug Class 3 | Number of Patients |
| --- | --- | --- |
| Agents Acting on the Renin-Angiotensin System | ACE Inhibitors, Plain | 107 |
| | Angiotensin II Receptor Blockers (ARBs), Plain | 62 |
| Agents Acting on the Renin-Angiotensin System | Angiotensin II Receptor Blockers (ARBs), Combinations | 11 |
| All Other Therapeutic Products | All Other Therapeutic Products | 13 |
| Anabolic Agents for Systemic Use | Other Mineral Supplements | 29 |
| Analgesics | Opioids | 66 |
| | Other Analgesics and Antipyretics | 132 |
| Anesthetics | Anesthetics, General | 1 |
| | Anesthetics, Local | 23 |
| Antianemic Preparations | Iron Preparations | 32 |
| | Vitamin B12 and Folic Acid | 42 |
| Antibacterials for Systemic Use | Beta-Lactam Antibacterials, Penicillins | 13 |
| | Other Antibacterials | 8 |
| | Other Beta-Lactam Antibacterials | 5 |
| | Quinolone Antibacterials | 7 |
| | Sulfonamides | 6 |
| | Tetracyclines | 1 |
| Antibiotics and Chemotherapeutics for Determatological Use | Antibiotics for Topical Use | 2 |
| | Chemotherapeutics for Topical Use | 1 |

K200788 - Page 22 of 29

{22}

K200788 - Page 23 of 29
| Therapeutic Drug Class 2 | Therapeutic Drug Class 3 | Number of Patients |
| --- | --- | --- |
| Antidiarrheals, Intestinal Inflammatory/Antiinfective Agents | Antidiarrheal Microorganisms | 10 |
| | Antipropulsives | 7 |
| | Intestinal Adsorbents | 1 |
| | Intestinal Antiinflammatory Agents | 35 |
| | Other Antidiarrheals | 2 |
| Antiemetics and Antinauseants | Antiemetics and Antinauseants | 19 |
| Antiepileptics | Antiepileptics | 110 |
| Antifungals for Dermatologic Use | Antifungals for Systemic Use | 1 |
| | Antifungals for Topical Use | 23 |
| Antigout Preparations | Antigout Preparations | 21 |
| Antihistamines for Systemic Use | Antihistamines for Systemic Use | 24 |
| Antihypertensives | Antiadrenergic Agents, Generally Acting | 5 |
| | Antiadrenergic Agents, Peripherally Acting | 6 |
| | Arteriolar Smooth Muscle, Agents Acting on | 8 |
| | Other Antihypertensives | 1 |
| Antiinflammatory and Antirheumatic Products | Antiinflammatory and Antirheumatic Products, Non-Steroids | 34 |
| Antimycotics for Systemic Use | Antimycotics for Systemic Use | 5 |
| Antiobesity Preparations, Excl. Diet Products | Antiobesity Preparations, Excl. Diet Products | 3 |
| Anti-Parkinson Drugs | Anticholinergic Agents | 2 |
| | Dopaminergic Agents | 16 |
| Antiprotozoals | Agents Against Amoebiasis and Other Protozoal Diseases | 1 |
| | Antimalarials | 5 |
| Antiseptics and Disinfectants | Antiseptics and Disinfectants | 1 |
| Antithrombotic Agents | Antithrombotic Agents | 237 |
| Antivirals for Systemic use | Direct Acting Antivirals | 5 |
| Beta Blocking Agents | Beta Blocking Agents | 147 |
| | Beta Blocking Agents and Thiazides | 1 |
| Bile and Liver Therapy | Bile Therapy | 1 |
| Blood Substitutes and Perfusion Solutions | Irrigating Solutions | 4 |
| Calcium Channel Blockers | Selective Calcium Channel Blockers with Direct Cardiac Effects | 16 |
| | Selective Calcium Channel Blockers with Mainly Vascular Effects | 64 |
| Calcium Homeostasis | Anti-Parathyroid Agents | 1 |

{23}

K200788 - Page 24 of 29
| Therapeutic Drug Class 2 | Therapeutic Drug Class 3 | Number of Patients |
| --- | --- | --- |
| | Parathyroid Hormones and Analogues | 1 |
| Cardiac Therapy | Antiarrhythmics, Class I and III | 10 |
| | Cardiac Glycosides | 6 |
| | Cardiac Stimulants, Excl. Cardiac Glycosides | 4 |
| | Other Cardiac Preparations | 5 |
| | Vasodilators Used in Cardiac Diseases | 11 |
| Corticosteroids for Systemic use | Corticosteroids for Systemic use, Plain | 4 |
| Corticosteroids, Dermatological Preparations | Corticosteroids, Plain | 10 |
| Cough and Cold Preparations | Cough Suppressants, Excl. Combinations with Expectorants | 16 |
| | Expectorants, Excl. Combinations with Cough Suppressants | 10 |
| Digestives, Incl. Enzymes | Digestives, Incl. Enzymes | 10 |
| Diuretics | Aldosterone Antagonists and Other Potassium-Sparing Agents | 20 |
| | High-Ceiling Diuretics | 53 |
| | Low-Ceiling Diuretics, Excl. Thiazides | 3 |
| | Low-Ceiling Diuretics, Thiazides | 45 |
| Drugs for Acid Related Disorders | Antacids | 1 |
| | Drugs for Peptic Ulcer and Gastro- Oesophageal Reflux Disease (GORD) | 133 |
| Drugs for Constipation | Drugs for Constipation | 307 |
| Drugs for Functional Gastrointestinal Disorders | Belladonna and Derivatives, Plain | 4 |
| | Drugs for Functional Gastrointestinal Disorders | 21 |
| | Propulsives | 7 |
| Drugs for Obstructive Airway Diseases | Adrenergics, Inhalants | 53 |
| | Other Drugs for Obstructive Airway Diseases, Inhalants | 54 |
| | Other Systemic Drugs for Obstructive Airway Diseases | 15 |
| Drugs for Treatment of Bone Diseases | Drugs Affecting Bone Structure and Mineralization | 12 |
| Drugs Used in Diabetes | Blood Glucose Lowering Drugs, Excl. Insulins | 359 |

{24}

K200788 - Page 25 of 29
| Therapeutic Drug Class 2 | Therapeutic Drug Class 3 | Number of Patients |
| --- | --- | --- |
| | Insulins and Analogues | 347 |
| Ectoparasiticides, Incl. Scabicides, Insectides, and Repellents | Ectoparasiticides, Incl. Scabicides | 1 |
| Emollients and Protectives | Emollients and Protectives | 1 |
| Endocrine Therapy | Hormone Antagonists and Related Agents | 3 |
| | Hormones and Related Agents | 5 |
| Gynecological Antiinfectives and Antiseptics | Antiinfectives and Antiseptics, Excl. Combinations with Corticosteroids | 4 |
| Immunosuppressants | Immunosuppressants | 12 |
| Lipid Modifying Agents | Lipid Modifying Agents, Plain | 263 |
| Mineral Supplements | Calcium | 20 |
| | Other Mineral Supplements | 29 |
| | Potassium | 24 |
| Muscle Relaxants | Muscle Relaxants, Centrally Acting Agents | 11 |
| Nasal Preparations | Decongestants and Other Nasal Preparations for Topical Use | 7 |
| Ophthalmologicals | Antiglaucoma Preparations and Miotics | 51 |
| | Antiinfectives | 3 |
| | Antiinflammatory Agents | 5 |
| | Decongestants and Antiallergics | 8 |
| | Ocular Vascular Disorder Agents | 1 |
| | Other Ophthalmologicals | 1 |
| Other Alimentary Tract and Metabolism Products | Other Alimentary Tract and Metabolism Products | 4 |
| | Other Mineral Supplements | 29 |
| Other Dermatological Preparations | Other Dermatological Preparations | 2 |
| Other Drugs for Disorders of the Musculo-Skeletal System | Other Drugs for Disorders of the Musculo-Skeletal System | 1 |
| Other Nervous System Drugs | Drugs Used in Addictive Disorders | 3 |
| | Other Nervous System Drugs | 1 |
| | Parasympathomimetics | 1 |
| Pituitary and Hypothalamic Hormones and Analogues | Posterior Pituitary Lobe Hormones | 1 |
| Preparations for Treatment of Wounds and Ulcers | Cicatrizants | 1 |
| Psycholeptics | Antipsychotics | 16 |
| | Anxiolytics | 48 |
| | Hypnotics and Sedatives | 58 |
| Psychonaleptics | Anti-Dementia Drugs | 12 |
| | Antidepressants | 147 |

{25}

K200788 - Page 26 of 29
| Therapeutic Drug Class 2 | Therapeutic Drug Class 3 | Number of Patients |
| --- | --- | --- |
| | Psycholeptics and Psychanaleptics in Combination | 8 |
| | Psychostimulants, Agents Used for ADHD and Nootropics | 13 |
| Sex Hormones and Modulators of the Genital System | Androgens | 6 |
| | Estrogens | 13 |
| | Hormonal Contraceptives for Systemic Use | 8 |
| | Other Sex Hormones and Modulators fo the Genital System | 2 |
| | Progestogens | 3 |
| | Progestogens and Estrogens in Combination | 1 |
| Stomatological Preparations | Stomatological Preparations | 1 |
| Throat Preparations | Throat Preparations | 2 |
| Thyroid Therapy | Antithyroid Preparations | 6 |
| | Thyroid Preparations | 96 |
| Tonics | Other Mineral Supplements | 29 |
| Topical Products for Joint and Muscular Pain | Topical Products for Joint and Muscular Pain | 3 |
| Urologicals | Drugs Used in Benign Prostatic Hypertrophy | 40 |
| | Urologicals | 18 |
| Vasoprotectives | Agents for Treatment of Hemorrhoids and Anal Fissures for Topical Use | 23 |
| | Capillary Stabilizing Agents | 1 |
| Vitamins | Ascorbic Acid (Vitamin C), Incl. Combinations | 19 |
| | Calcium | 20 |
| | Multivitamins, Combinations | 44 |
| | Other Plain Vitamin Preparations | 6 |
| | Vitamin A and D, Incl. Combinations of the Two | 123 |
| | Vitamin B1, Plain and in Combination with Vitamin B6 and B12 | 7 |
| | Vitamin B-Complex, Incl. Combinations | 1 |

{26}

K200788 - Page 27 of 29

Accuracy at extreme glucose values:

An additional study was conducted to further assess the performance of the Assure Titanium Blood Glucose Monitoring System at the extreme upper and lower ends of the claimed measuring range. The sponsor altered 100 capillary whole blood samples from healthy donors, by spiking or allowing samples to glycolyze, to obtain 50 samples with glucose concentrations below 80 mg/dL (22.3-72.8 mg/dL, as measured by the comparator method) and 50 samples with glucose concentrations above 300 mg/dL (303.5-577.3 mg/dL, as measured by the comparator method).

Samples were tested on the Assure Titanium Blood Glucose Meter by intended use operators, using test strips from 3 lots and compared with the results obtained on the comparator method (YSI 2300 STAT Plus). The results are summarized below:

Results for Glucose Concentrations &lt; 80 mg/dL:

| Within ±5 mg/dL | Within ±10 mg/dL | Within ±12 mg/dL | Within ±15 mg/dL |
| --- | --- | --- | --- |
| 43/50
(86%) | 49/50
(98%) | 50/50
(100%) | 50/50
(100%) |

Results for Glucose Concentrations &gt; 300 mg/dL:

| Within ±5 % | Within ±10 % | Within ±12 % | Within ±15 % | Within ±20 % |
| --- | --- | --- | --- | --- |
| 32/50
(64%) | 46/50
(92%) | 50/50
(100%) | 50/50
(100%) | 50/50
(100%) |

2. Matrix Comparison:
Not applicable.

C Clinical Studies:

1. Clinical Sensitivity:
Not applicable.

2. Clinical Specificity:
Not applicable.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.

D Clinical Cut-Off:
Not applicable.

{27}

K200788 - Page 28 of 29

# E Expected Values/Reference Range:

Expected values for non-diabetics

Expected blood glucose values for non-pregnant adults without diabetes¹

Fasting* &lt;100 mg/dL

2 hours after meals &lt;140 mg/dL

*Fasting is defined as no caloric intake for at least eight hours. Consult the patient's physician to determine the range that is appropriate for your patients.

1. American Diabetes Association. Standards of medical care in diabetes-2021. Diabetes Care. 2021; 44(1); p.S17.

# F Other Supportive Instrument Performance Characteristics Data:

1. Hematocrit Study:

The effect of hematocrit on the performance of the Assure Titanium Blood Glucose Monitoring System was evaluated at 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65% and 70% hematocrit levels, and at 5 glucose concentrations (30-50, 51-110, 111-150, 151-250 and 251-400 mg/dL). Each sample was tested in replicates of 10 using 10 meters and 3 lots of test strips, for a total of 30 replicates per sample. The values were compared with the glucose measurements obtained from the comparator method (YSI 2300 STAT Plus). The results of the study demonstrated adequate performance to support the claimed hematocrit range of 10-70%.

2. Altitude Study:

A simulated high-altitude study was conducted in a pressure chamber to simulate the effects of sea level (&lt;500 ft) and high-altitude (10,000 ft) on the Assure Titanium Blood Glucose Monitoring System. Venous whole blood samples adjusted to 3 glucose concentrations (55-77, 114-144 and 316-356 mg/dL) were tested in replicates of 10, using 10 meters and 3 lot of test strips, for a total of 30 replicates per sample, per condition. Values measured by the candidate device were compared with the glucose measurements obtained from the comparator method (YSI 2300 STAT Plus). The results of the study support the claim that the Assure Titanium Blood Glucose Monitoring System can be operated at altitudes of up to 10,000 ft (3,048 meters).

3. System Operating Conditions:

To assess the performance of the Assure Titanium Blood Glucose Monitoring System when used under various operating temperature and humidity conditions, the system was tested at four different temperature and humidity conditions including low temperature/low humidity (8 °C/10% RH), low temperature/high humidity (8 °C/90% RH), high temperature/low humidity (40 °C/10% RH) and high temperature/high humidity (40 °C/90% RH). Each of 3 venous whole blood glucose levels (55-77, 114-144 and 316-356 mg/dL) were tested by 10 meters, using 3 lots of test strips, for a total of 10 replicates per sample, per condition. Values measured by the Assure Titanium Blood Glucose Monitoring System were compared to the comparator method (YSI 2300 STAT Plus). The study results support the labeled operating conditions claim of 8-40°C (46-104°F) and 10-90% RH.

{28}

K200788 - Page 29 of 29

4. Sample Volume Study:
The sponsor performed a study to support the claimed minimum sample volume of 0.5 µL for the Assure Titanium Blood Glucose Monitoring System. Venous whole blood samples with 3 glucose concentrations (50-65, 100-120 and 200-250 mg/dL) were tested at 6 sample volumes (0.1, 0.3, 0.5, 1.0 and 5.0 and 10.0 µL) using 3 lots of test strips. Values obtained were compared to the comparator method (YSI 2300 STAT Plus). Results support the claimed minimum sample volume of 0.5 µL for the system. The meter has an error message displayed if enough blood is not added to the test strip. This feature was validated and was shown to function as intended.

5. Flex Studies:
Intermittent sampling, sample perturbation, testing with used test strips and a variety of mechanical/durability testing (i.e., drop, vibration and compression testing) was completed by the sponsor. The testing performed demonstrated that the Assure Titanium Blood Glucose Monitoring System is robust to these expected use scenarios.

6. Cleaning and Disinfection Robustness Evaluation:
The device is intended for multiple-patient use. Disinfection efficacy studies were performed on the on the exterior meter materials by an outside commercial testing laboratory, demonstrating complete inactivation of Hepatitis B Virus (HBV) with the chosen disinfectant, Super Sani-Cloth Germicidal Disposable Wipe (EPA Registration Number 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 10,950 cycles of cleaning and disinfection using the chosen disinfectant. The robustness studies were designed to simulate cleaning and disinfection over the 3-year multi-patient use life of the meter. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

7. Electromagnetic Compatibility and Electrical Safety:
The sponsor provided documentation certifying that acceptable electrical safety and electromagnetic compatibility (EMC) testing had been performed and the system was found to be compliant.

8. Test Strip Lot Release Protocol:
The test strip lot release protocol and acceptance criteria were reviewed and found to be acceptable.

VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.