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.

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)
1. 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
1. 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.

AI/ML Overview

The provided text describes the performance evaluation of the PixoTest Blood Glucose Monitoring System (BGMS). Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the PixoTest BGMS meets "accuracy specifications" and "usability and risk assessment specifications" as acceptance criteria, but it does not explicitly define the numerical acceptance criteria in the provided text. It states that the study results "demonstrate that the accuracy specifications of PixoTest BGMS meet the acceptance criteria" and "the usability (via questionnaire), user accuracy, and risk assessment specifications of PixoTest BGMS meet the acceptance criteria."

Therefore, a table showing specific numerical acceptance criteria and corresponding performance metrics cannot be fully constructed from the provided text.

2. Sample Size Used for the Test Set and Data Provenance

System Accuracy Studies (Both iPhone 5/5S and iPhone 6/6S):
- Sample Size: 100 different subjects for each study.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The phrase "evaluations conducted on subjects" implies prospective data collection from human participants. No country of origin is mentioned.
Usability/User Performance Studies (Both iPhone 5/5S and iPhone 6/6S):
- Sample Size: 105 subject first-time users for each study.
- Data Provenance: Not explicitly stated, but implies prospective data collection from human participants. No country of origin is mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study involving human readers is mentioned. The studies focus on the device's performance compared to a laboratory reference (YSI 2300 Analyzer) and user performance of the device itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation of the algorithm and device was a primary focus. The "System Accuracy" studies compare the device's measurements directly against a laboratory reference instrument (YSI 2300 Analyzer), which represents the "algorithm only" performance (how accurately the device measures glucose). The PixoTest BGMS is essentially a standalone measurement device with a connected app for display.

7. The Type of Ground Truth Used

System Accuracy Studies: The ground truth for the system accuracy studies was established by comparing the PixoTest BGMS measurements to values obtained from a YSI 2300 Analyzer lab instrument. The YSI 2300 Analyzer is a common laboratory reference method for glucose measurement, hence, this represents a reference standard/laboratory gold standard.
Usability/User Performance Studies: The ground truth for user accuracy in these studies would likely be based on whether the results obtained by lay users were within acceptable ranges compared to a reference measurement (though not explicitly detailed for this specific aspect, it's implied by "User Accuracy lay users can obtain accurate results"). Usability itself was assessed via a questionnaire, which is a subjective rather than objective ground truth, but standard for usability assessments.

8. The Sample Size for the Training Set

The document does not provide information about a training set for the device's development or any machine learning models. The studies described are validation studies for the device itself.

9. How the Ground Truth for the Training Set Was Established

Since no training set information is provided, this question cannot be answered from the given text. It's important to note that for a blood glucose monitor system, the "training" aspect would typically be during the calibration and development of the system's chemical and optical components, rather than a machine learning training set in the conventional sense. The "ground truth" during development would involve extensive testing against reference methods.

Summary

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the bottom profile being the largest and the top profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: (949) 218-0929 Fax: (949) 218-0928

Date Summary Prepared: October 25, 2017

1. Name of the Device:
  PixoTest Blood Glucose Monitoring System
1. Common or Usual Name: Blood Glucose Monitoring System

Product Code	Classification	Regulation Section	Panel
NBW; System, Test, BloodGlucose, 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)
1. 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
1. 10 Pcs Kit - includes PixoTest Standard Card and 10 Pcs PixoTest Glucose Test Strip

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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 –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,in-vitro diagnostic use only by individuals withdiabetes at home		OTC: For single-patient use only, in-vitro diagnostic use only byindividuals with diabetes at home; andProfessional: For multiple-patient useby health care professional in clinicalsetting
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.(3000 m)	13,123 ft.(4000 m)
Test Strip OperatingTemperature	50-95°F(10-35°C)		5-104°F(10-40°C)
Test Strip OperatingHumidity	10-90% relative humidity		< 85% relative humidity
Test Strip Shelf-Life		24 months	18 months
Test Strip StorageTemperature	50-104°F(10-40°C)		36-86°F(2-30°C)
Test Strip Reagent	Glucose Oxidase		Glucose Dehydrogenase
Interference Substances	Acetaminophen, salicylates, uric acid, ascorbicacid(vitamin C), and other reducing substances		Ascorbic acid, Galactose, Bilirubin,Ceftriaxone
Compatible Device/OS		iPhone 5/5S/6/6S; iOS 8 or above	N/A, Meter
Device Dimension	iPhone 5/5S:4.87 x 2.31 x 0.3 in.(123.8 x 58.6 x 7.6mm)	iPhone 6/6S:5.44 x 2.64 x 0.28 in.(138.3 x 67.1 x 7.1mm)	Meter:4.1 x 2 x 0.9 in.(104.5 x 51.5 x 22 mm)
Device Weight	iPhone 5/5S:112g	iPhone 6/6S:143f	Meter:55g without battery60g with battery
Device StorageTemperature	N/A		Meter:-40-158°F(-40-70°C)
Power Supply	iPhone 5/5S6/6S: Built-in rechargeablelithium-ion battery		Meter: 1 type CR 2032 or equivalentlithium battery
Battery Life	N/A		1000 tests
Device Display		LCD
Display Area	iPhone 5/5S:4 in.	iPhone 6/6S:4.7 in.	Meter: 2 in.
Memory Capacity		1000 blood glucose test results with date andtime	200 blood glucose test results withdate 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
1. 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:

1. User Accuracy lay users can obtain accurate results while using PixoTest BGMS
1. 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.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.