(364 days)
Not Found
No
The document describes a standard glucose monitoring system using glucose oxidase test methodology and does not mention any AI or ML components.
No.
The device is described as a blood glucose monitoring system intended for the quantitative measurement of glucose in fresh capillary whole blood and for monitoring the effectiveness of diabetes control. It is explicitly stated that it is "not in the diagnosis of or screening for diabetes" and is "for self-testing outside the body (in vitro diagnostic use)". This indicates it is a diagnostic or monitoring device, not a therapeutic one that treats or cures a condition.
Yes
The "Intended Use" section states: "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... as an aid to monitor the effectiveness of diabetes control." This indicates its purpose is to provide objective data for assessing a medical condition.
No
The device description explicitly lists multiple hardware components as part of the system, including the PixoTest Glucose Test Strip, PixoTest Standard Card, and PixoTest Uni-Clip, in addition to the PixoHealth App and a compatible smartphone.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states: "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."
This statement clearly indicates that the device is intended for use on samples taken from the human body (blood) to provide information about a physiological state (glucose levels related to diabetes), and that this testing is performed outside of the body (in vitro). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 in the diagnosis of or screening for diabetes and is not intended for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
PixoTest BGMS consists of the following devices:
- PixoTest Glucose Test Strip (single-use) abbreviated as Glucose Test Strip
- PixoTest Control Solutions (2 levels 1 and 2) optional
- PixoTest Standard Card
- PixoTest Uni-Clip
- PixoHealth App
- Requires compatible smartphone (iPhone 5/5S/6/6S) not provided by iXensor
iXensor provides the following kits:
- Starter (5 Pcs) Kit- includes PixoTest Standard Card, PixoTest Uni-Clip, and 5 Pcs Glucose Test Strip
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
The system is not intended for use on neonates.
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
System Accuracy (iPhone 5/5S): 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.
System Accuracy (iPhone 6/6S): 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).
Usability/User Performance (iPhone 5/5S): 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.
Usability/User Performance (iPhone 6/6S): 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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 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 User Accuracy (lay users can obtain accurate results while using PixoTest BGMS) and 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 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 User Accuracy (lay users can obtain accurate results while using PixoTest BGMS) and 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 study results demonstrate that the usability (via questionnaire), user accuracy, and risk assessment specifications of PixoTest BGMS meet the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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.
1
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
2
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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3
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
-
- Name of the Device:
PixoTest Blood Glucose Monitoring System
- Name of the Device:
-
- Common or Usual Name: Blood Glucose Monitoring System
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW; System, Test, Blood | |||
| 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)
-
- 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
-
- 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.
4
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 with
diabetes at home | | OTC: For single-patient use only, in-
vitro diagnostic use only by
individuals with diabetes at home; and
Professional: For multiple-patient use
by health care professional in clinical
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.
(3000 m) | 13,123 ft.
(4000 m) |
| Test Strip Operating
Temperature | 50-95°F
(10-35°C) | | 5-104°F
(10-40°C) |
| Test Strip Operating
Humidity | 10-90% relative humidity | |