PixoTest Blood Glucose Monitoring System

K163087 · Ixensor Company , Ltd. · NBW · Nov 2, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163087
• Device Name: PixoTest Blood Glucose Monitoring System
• Applicant: Ixensor Company , Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The PixoTest Blood Glucose Monitoring System is comprised of PixoTest Glucose Test Strip, PixoTest Uni-Clip, and the PixoHealth App as the display component of the system. The PixoTest Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. The PixoTest Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended for single person use only and should not be shared. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.

Device Story

System uses smartphone camera to measure blood glucose; consists of PixoTest Glucose Test Strip with integrated lancet, PixoTest Uni-Clip, and PixoHealth App. User applies capillary blood to test strip; glucose oxidase reaction produces color change on reagent pad. Uni-Clip attaches strip to iPhone (5, 5S, 6, 6S) camera lens. App captures photograph of color change; processes image to calculate glucose concentration. Results displayed on smartphone screen within 8 seconds. Intended for home self-testing by patients. Benefits include convenient monitoring of diabetes control via mobile device. System requires manual cleaning/disinfection of phone and clip after each use to prevent pathogen transmission.

Clinical Evidence

User performance study conducted with 105 lay users testing their own capillary blood on iPhone 5S and 6S. Results compared to YSI 2300 laboratory analyzer. For glucose <75 mg/dL, 100% of results were within ±15 mg/dL. For glucose ≥75 mg/dL, 100% of results were within ±20% of the reference method.

Technological Characteristics

Reflectance photometry; glucose-oxidase reagent chemistry; 1.8 μL sample volume; measuring range 40-500 mg/dL; 8-second measurement time; smartphone-based (iPhone 5/5S/6/6S) display via PixoHealth App; connectivity via smartphone integration; single-use test strips with integrated lancet.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for self-testing by people with diabetes at home to monitor diabetes control. Not for diagnosis or screening of diabetes; not for use on neonates.

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

• Roche Diagnostics Corporations Accu-Chek Active System (k021827)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 2, 2017

iXENSOR COMPANY LTD. C/O FENG-YU LEE IVDD REGULATORY CONSULTANT 29222 RANCHO VIEJO RD, SUITE 218 SAN JAN CAPISTRANO CA 92675

Re: K163087

Trade/Device Name: PixoTest Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: October 25, 2017 Received: October 30, 2017

Dear Feng-Yu Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k163087

### Device Name

PixoTest Blood Glucose Monitoring System

### Indications for Use (Describe)

The PixoTest Blood Glucose Monitoring System is comprised of PixoTest Glucose Test Strip, PixoTest Uni-Clip, and the PixoHealth App as the display component of the system.

The PixoTest Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip.

The PixoTest Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended for single person use only and should not be shared. It is not in the diagnosis of or screening for diabetes and is not intended for use on neonates.

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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## iXensor

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

The assigned 510(k) number is: k163087

- Submitter Identification: 1. iXensor Co. Ltd. 6F, No. 9, Aly. 2, Ln.35, Jihu Rd., Neihu Dist., Taipei City 114, Taiwan
c/o IVDD Regulatory Consultant Contact Person: Mrs. Feng-Yu Lee Address: 29222 Rancho Viejo Rd., Suite 218, San Juan Capistrano, CA 92675 Phone: [phone] Fax: [phone]

Date Summary Prepared: October 25, 2017

- 2. Name of the Device:
PixoTest Blood Glucose Monitoring System

- 3. Common or Usual Name: Blood Glucose Monitoring System

| Product Code | Classification | Regulation Section | Panel |
|-------------------------------------------------------|----------------|--------------------|-----------------------|
| NBW; System, Test, Blood<br>Glucose, Over-the-Counter | Class II | 21 CFR 862.1345 | Clinical Chemistry 75 |

#### 4. Device Description:

PixoTest BGMS consists of the following devices:

- PixoTest Glucose Test Strip (single-use) abbreviated as Glucose Test Strip 1)
- PixoTest Control Solutions (2 levels 1 and 2) optional 2)
- 3) PixoTest Standard Card
- PixoTest Uni-Clip 4)
- ર) PixoHealth App
- Requires compatible smartphone (iPhone 5/5S/6/6S) not provided by iXensor 6)

iXensor provides the following kits:

- Starter (5 Pcs) Kit- includes PixoTest Standard Card, PixoTest Uni-Clip, and 5 Pcs 1) Glucose Test Strip
- 2) 10 Pcs Kit - includes PixoTest Standard Card and 10 Pcs PixoTest Glucose Test Strip

The PixoTest BGMS uses glucose oxidase test methodology to measure capillary whole blood glucose levels from 40 to 500 mg/dL. The system will display "Hi" when the results are above 500 mg/dL and "Lo" when the results are below 40mg/dL.

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## iXensor

### Expected glucose values without diabetes*

| Blood Glucose Normal Range | |
|-----------------------------|---------------------|
| Status | Glucose Level |
| Fasting for 8 Hours | Less than 100 mg/dL |
| Oral Glucose Tolerance Test | Less than 140 mg/dL |

* Diagnosing Diabetes and Learning About Prediabetes- Association (ADA) [Electronic Version] Retrieved Apr. 27, 2017 from www.diabetes.org/diabetes-basics/diagnosis/

#### న. Intended Use:

The PixoTest Blood Glucose Monitoring System is comprised of PixoTest Glucose Test Strip. PixoTest Uni-Clip, and the PixoHealth App as the display component of the system. The PixoTest Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. The PixoTest Blood Glucose Monitoring System is intended for self-testing outside of the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended for single person use only and should not be shared. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.

#### 6. Predicate Device Information

PixoTest BGMS is substantially equivalent to the following device: BGMS Name: Accu-Chek Active System Device Company: Roche Diagnostics Corporation 510(K) Number: K021827

#### 7. Comparison to Predicate Devices:

| Specification | Subject Device – PixoTest BGMS | | Predicate Device –<br>Roche Accu-Chek Active System |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | for iPhone 5/5S | for iPhone 6/6S | |
| Similarities & Differences | | | |
| Indications for Use | Over-The-Counter: For single-patient use only,<br>in-vitro diagnostic use only by individuals with<br>diabetes at home | | OTC: For single-patient use only, in-<br>vitro diagnostic use only by<br>individuals with diabetes at home; and<br>Professional: For multiple-patient use<br>by health care professional in clinical<br>setting |
| Test Principle | Reflectance photometry | | |
| Sample Type | Capillary whole blood | | |
| Sample Volume | 1.8 μL | | 1-2 μL |
| Primary Site Testing | Fingertip | | |
| Alternative Site Testing | N/A | | Forearm, calf, thigh, upper arm, palm |
| Unit of Measurement | mg/dL | | |
| Measuring Range | | 40-500 mg/dL | 10-600 mg/dL |
| Measuring Time | | 8 seconds | 5 seconds |
| Hematocrit | | 20-60% | 30-55% |
| Maximum Altitude | | 9,843 ft.<br>(3000 m) | 13,123 ft.<br>(4000 m) |
| Test Strip Operating<br>Temperature | 50-95°F<br>(10-35°C) | | 5-104°F<br>(10-40°C) |
| Test Strip Operating<br>Humidity | 10-90% relative humidity | | < 85% relative humidity |
| Test Strip Shelf-Life | | 24 months | 18 months |
| Test Strip Storage<br>Temperature | 50-104°F<br>(10-40°C) | | 36-86°F<br>(2-30°C) |
| Test Strip Reagent | Glucose Oxidase | | Glucose Dehydrogenase |
| Interference Substances | Acetaminophen, salicylates, uric acid, ascorbic<br>acid<br>(vitamin C), and other reducing substances | | Ascorbic acid, Galactose, Bilirubin,<br>Ceftriaxone |
| Compatible Device/OS | | iPhone 5/5S/6/6S; iOS 8 or above | N/A, Meter |
| Device Dimension | iPhone 5/5S:<br>4.87 x 2.31 x 0.3 in.<br>(123.8 x 58.6 x 7.6<br>mm) | iPhone 6/6S:<br>5.44 x 2.64 x 0.28 in.<br>(138.3 x 67.1 x 7.1<br>mm) | Meter:<br>4.1 x 2 x 0.9 in.<br>(104.5 x 51.5 x 22 mm) |
| Device Weight | iPhone 5/5S:<br>112g | iPhone 6/6S:<br>143f | Meter:<br>55g without battery<br>60g with battery |
| Device Storage<br>Temperature | N/A | | Meter:<br>-40-158°F<br>(-40-70°C) |
| Power Supply | iPhone 5/5S6/6S: Built-in rechargeable<br>lithium-ion battery | | Meter: 1 type CR 2032 or equivalent<br>lithium battery |
| Battery Life | N/A | | 1000 tests |
| Device Display | | LCD | |
| Display Area | iPhone 5/5S:<br>4 in. | iPhone 6/6S:<br>4.7 in. | Meter: 2 in. |
| Memory Capacity | | 1000 blood glucose test results with date and<br>time | 200 blood glucose test results with<br>date and time |
| Coding Procedure | Code Key | | |
| Voice Function | No | | |

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## iXensor

## Statement of No Differences:

For the reasons mentioned above, it can be concluded that the PixoTest BGMS are substantially equivalent to the Roche Accu-Chek Active System in commercial distribution, with respect to indications for use and technology.

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#### Technology Characteristics: 8.

PixoTest BGMS is a device that utilizes smartphone technology in conjunction with reflectance photometry and glucose-oxidase chemical reaction testing principles to measure the glucose level in human blood. A small drop of blood (minimum 1.8 microliter) is applied to the eyelet on top of the disposable PixoTest Glucose test strip with integrated lancet cartridge. The blood sample is then transferred to and absorbed by the test strip's glucose-oxidase impregnated reagent pad, which reacts with the glucose to produce a color change. The intensity of the color change is proportional to the glucose concentration present in the blood sample. After 8 seconds, the blood glucose measurement result is displayed on the smartphone screen via PixoHealth App.

### 9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Verification and validation tests were performed to evaluate the performance, functionality, and reliability of the PixoTest BGMS. The evaluations include precision, linearity and sensitivity, interference, sample volume, and hematocrit.

#### 10. Discussion of Clinical Tests Performed:

### System Accuracy (iPhone 5/5S):

A system accuracy study of the PixoTest BGMS was performed by comparing capillary whole blood glucose values on the PixoTest BGMS with values on YSI 2300 Analyzer lab instrument.

The evaluation was conducted on 100 different subjects using 2 PixoTest BGMS including compatible smartphone (iPhone 5S with PixoHealth App), taking duplicate measurements from 3 test strip reagent lots.

The study results demonstrate that the accuracy specifications of PixoTest BGMS meet the acceptance criteria.

### System Accuracy (iPhone 6/6S):

A system accuracy study of the PixoTest BGMS was performed by comparing capillary whole blood glucose values on the PixoTest BGMS with values on YSI 2300 Analyzer lab instrument.

The evaluation was conducted on 100 different subjects using 2 PixoTest BGMS including compatible smartphone (iPhone 6S with PixoHealth App), taking duplicate measurements from 3 test strip reagent lots (6 measurements total per subject).

The study results demonstrate that the accuracy specifications of PixoTest BGMS meet the acceptance criteria.

## Usability/User Performance (iPhone 5/5S):

A user performance study was performed to demonstrate the following:

- 1) User Accuracy lay users can obtain accurate results while using PixoTest BGMS
- 2) Usability English speaking and reading lay users find PixoTest BGMS system easy to use and user manual is easily understandable across all educational backgrounds.

The evaluation was conducted on 105 subject first time users with 3 lots of PixoTest BGMS including compatible smartphones (iPhone 5S with Pixo Health App), all accessories, and accompanying documents

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The study results demonstrate that the usability (via questionnaire), user accuracy, and risk assessment specifications of PixoTest BGMS meet the acceptance criteria.

Usability/User Performance (iPhone 6/6S):

A user performance study was performed to demonstrate the following:

- 3) User Accuracy lay users can obtain accurate results while using PixoTest BGMS
- 4) Usability English speaking and reading lay users find PixoTest BGMS system easy to use and user manual is easily understandable across all educational backgrounds.

The evaluation was conducted on 105 subject first time users with 3 lots of PixoTest BGMS including compatible smartphones (iPhone 6S with PixoHealth App), all accessories, and accompanying documents.

The study results demonstrate that the usability (via questionnaire), user accuracy, and risk assessment specifications of PixoTest BGMS meet the acceptance criteria.

- Conclusions: 11.
Performance evaluations of the PixoTest BGMS demonstrate substantial equivalence to the predicate device, Roche Accu-Chek Active System.