(168 days)
The POPS!® one Blood Glucose Monitoring System is comprised of the POPS!® one blood glucose meter, the POPS!® one blood glucose sensor modules, and the POPS!® mobile application as the display component.
The POPS!® one Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.
The POPS!® one Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.
The POPS!® one Blood Glucose Monitoring System is designed to make blood glucose testing and diabetes management easier and more convenient. The traditional test kit is replaced by a low-profile meter that contains everything needed for testing and requires no assembly. The meter pairs with a mobile app installed on the user's phone via Bluetooth, allowing the meter to perform glucose testing and send the results to the app where they are communicated to the user and automatically stored.
The POPS!® one Blood Glucose Monitoring System contains the following:
- . POPS!® one blood glucose meter works directly with the POPS!® app installed on the user's mobile phone. The meter performs a blood glucose test and sends the result to the POPS!" app.
- . POPS!® one blood glucose sensor module is individually packed and sterile. It contains 3 test sites with separate foil covers; each containing a lancet and test strip. The user inserts the sensor module in the meter and replaces a used sensor module with a new once all 3 test sites have been used. The sensor module not only provides all components for performing a glucose test to the user in a convenient, self-contained format but it also provides a new lancet for each test; preventing lancet re-use.
- . POPS!® mobile application acts as the primary interface with users; enabling them to test, communicating blood glucose results and messages, and allowing them to monitor trends on their phone.
The document describes the POPS!® one Blood Glucose Monitoring System and its substantial equivalence to a predicate device (TD-4277 Blood Glucose Monitoring System).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the POPS!® one Blood Glucose Monitoring System met all performance criteria as assessed by non-clinical and clinical studies. However, specific acceptance criteria values (e.g., accuracy percentages for various glucose ranges as per ISO 15197 or FDA guidance) are NOT explicitly listed in the provided text. The document generally refers to "performance criteria" being met, implying compliance with the FDA Guidance issued on October 11, 2016: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.
Without the specific numerical acceptance criteria from that guidance, a table comparing them to reported device performance cannot be fully constructed from the provided text. The document only mentions that the system accuracy was "confirmed."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling." However, the specific sample size used for the test set (number of participants, number of samples) and the data provenance (e.g., country of origin, retrospective or prospective) are NOT provided in the text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document describes a blood glucose monitoring system, which typically involves a single user taking a measurement and is not generally subject to MRMC studies designed for image interpretation or diagnosis by multiple readers. Therefore, an MRMC comparative effectiveness study was not done in the context of this device's evaluation as described.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The device is a "Blood Glucose Monitoring System" intended for "Self-Monitoring." Its core function is the quantitative measurement of glucose from a blood sample using a meter and sensor module, with results displayed via a mobile app. This inherently involves human interaction (blood sampling, operating the device). Therefore, a purely "standalone" algorithm-only study, without human interaction, is not applicable or described for this type of medical device. The "system accuracy" would be evaluated with human users.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation (e.g., reference lab method, YSI analyzer). For blood glucose monitoring systems, ground truth is typically established by comparing device readings to a highly accurate laboratory reference method.
8. Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This type of information is typically relevant for AI/ML-driven devices that learn from data, and while the device uses software (for display and storage), it's not described as having a learning algorithm in the context of its glucose measurement. The "non-clinical testing" likely involved engineering and analytical validation with simulated or controlled samples, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not applicable or provided.
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November 30, 2018
TaiDoc Technology Corporation Anne Kuo Regulatory Affairs Senior Specialist 6F. No.127. Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan
Re: K181588
Trade/Device Name: POPS! one Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 26, 2018 Received: October 31, 2018
Dear Anne Kuo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K181588
Device Name
POPS!® one Blood Glucose Monitoring System
Indications for Use (Describe)
The POPS!® one Blood Glucose Monitoring System is comprised of the POPS!® one blood glucose meter, the POPS!® one blood glucose sensor modules, and the POPS!® mobile application as the display component.
The POPS!® one Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.
The POPS!® one Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☐ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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Image /page/3/Picture/0 description: The image shows the logo for TaiDoc, a company that specializes in medical devices. The logo consists of the word "TaiDoc" in gray, followed by three red hearts. Below the hearts is the website address "www.taidoc.com" in white text on a gray background. The logo is simple and clean, and the use of red hearts suggests a focus on health and well-being.
510(k) Summary
Assigned 510(k) number: K181588
In accordance with the requirements of 21 CFR 807.92, this summary is being provided to serve as basis for the substantial equivalence determination.
Submitter information
| Manufacturer | TaiDoc Technology Corporation |
|---|---|
| Address | 6F, No. 127, Wugong 2nd Rd. Wugu Dist.New Taipei City, Taiwan 24888 |
| Establishment Registration No. | 3004145393 |
| Date Prepared | November 30, 2018 |
| Correspondent | TaiDoc Technology Corporation |
| Correspondent Contact | Anne Kuo |
| Title | Regulatory Affairs Senior Specialist |
| Phone | +886-2-6625-8188 #1195 |
| ra.cert@taidoc.com.twanne.kuo@taidoc.com.tw | |
| Correspondent | POPS! Diabetes Care, Inc. |
| Correspondent Contact | Jennifer Englund |
| Title | Vice President, Clinical, Regulatory & Quality |
| Phone | 612-802-7606 |
| jennifer.englund@popsdiabetes.com |
Proposed Device Information
| Proprietary name | POPS!® one Blood Glucose Monitoring System |
|---|---|
| Common name | Blood Glucose Monitoring System |
| Product code | NBW, Blood Glucose Test System, Over-the-Counter |
| Classification panel | Clinical chemistry |
| Classification | Class II |
| Regulation citation | 21 CFR §862.1345, Glucose test system |
CONFIDENTIAL
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Image /page/4/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray letters, followed by three red hearts. Below the hearts is the website address "www.taidoc.com" in white letters on a gray background. The logo is simple and clean, with the hearts adding a touch of warmth and care.
泰博科技股份有限公司 TaiDoc Technology Corp. 新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888. Taiwan
Predicate Device Information
| Manufacturer | TaiDoc Technology Corporation |
|---|---|
| Proprietary Name | TD-4277 Blood Glucose Monitoring System |
| Common Name | Blood Glucose Monitoring System |
| 510(k) Number | K100322 |
Intended use
The POPS!" one Blood Glucose Monitoring System is comprised of the POPS!" one blood glucose meter, the POPS!® one blood glucose sensor modules, and the POPS!® mobile application as the display component.
The POPS!" one Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.
The POPS!® one Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.
Device Description
The POPS!® one Blood Glucose Monitoring System is designed to make blood glucose testing and diabetes management easier and more convenient. The traditional test kit is replaced by a low-profile meter that contains everything needed for testing and requires no assembly. The meter pairs with a mobile app installed on the user's phone via Bluetooth, allowing the meter to perform glucose testing and send the results to the app where they are communicated to the user and automatically stored.
The POPS!® one Blood Glucose Monitoring System contains the following:
- . POPS!® one blood glucose meter works directly with the POPS!® app installed on the user's mobile phone. The meter performs a blood glucose test and sends the result to the POPS!" app.
- . POPS!® one blood glucose sensor module is individually packed and sterile. It contains 3 test sites with separate foil covers; each containing a lancet and test strip. The user inserts the sensor module in the meter and replaces a used sensor module with a new once all 3 test sites have
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Image /page/5/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray letters, with three red hearts below it. Below the hearts is the website address "www.taidoc.com" in white letters on a gray background.
been used. The sensor module not only provides all components for performing a glucose test to the user in a convenient, self-contained format but it also provides a new lancet for each test; preventing lancet re-use.
- . POPS!® mobile application acts as the primary interface with users; enabling them to test, communicating blood glucose results and messages, and allowing them to monitor trends on their phone.
Test principle
The blood glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip within the Sensor Module. The system measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.
Summary of Technological Characteristics and Comparison to the Predicate
The POPS!" one Blood Glucose Monitoring System is substantially equivalent to the predicate device, both in terms of intended use and technological characteristics. The primary differences between the proposed and predicate device are design changes to simplify the glucose testing experience and allow communication of results and messages to the user to occur via the POPS!® app.
The similarities and differences between the predicate and proposed devices are summarized in Table 1 and 2 below.
| Characteristic | Predicate deviceTD-4277 | Proposed devicePOPS!® one |
|---|---|---|
| Operation principle | Electrochemical biosensor technology | Electrochemical biosensor technology |
| Detection method | Amperometric glucose biosensor | Amperometric glucose biosensor |
| Code calibration | No coding required | No coding required |
| Enzyme | Glucose dehydrogenase | Glucose dehydrogenase |
| Strip reaction time | 6 seconds | 6 seconds |
| Sample volume | 0.5 µL | 0.5 µL |
Table 1: Similarities between the Predicate and Proposed Devices
CONFIDENTIAL
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泰博科技股份有限公司 TaiDoc Technology Corp.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
| Characteristic | Predicate deviceTD-4277 | Proposed devicePOPS!® one |
|---|---|---|
| Measurement range | 20~600 mg/dL | 20~600 mg/dL |
| Hematocrit range | 20~60% | 20~60% |
| Measurement unit | mg/dL | mg/dL |
| Measurement modes | Test ModeAC (before meal)PC (after meal)Gen (not specified)QC (quality control) | Test ModeAC (before meal)PC (after meal)Gen (not specified)QC (quality control) |
| Strip indication light | Yes | Yes |
| Meter storage/transportation condition | -4 °F to 140°F, < 95% R.H. | -4 °F to 140°F, < 95% R.H. |
| Strip storage/transportation condition | 35.6ºF to 89.6ºF, < 85% R.H. | 35.6ºF to 89.6ºF, < 85% R.H. |
Table 2: Differences between the Predicate and Proposed Devices
| Characteristic | Predicate deviceTD-4277 | Proposed devicePOPS!® one |
|---|---|---|
| Physical Appearance | Image: TD-4277 device | Image: POPS! one device |
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Image /page/7/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray, with three red hearts underneath it. The hearts are evenly spaced and aligned horizontally.
泰博科技股份有限公司 TaiDoc Technology Corp.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
| Characteristic | Predicate deviceTD-4277 | Proposed devicePOPS!® one |
|---|---|---|
| Intended use | TD-4277 Blood Glucose MonitoringSystem is intended for use in thequantitative measurement of glucosein fresh capillary whole blood fromthe finger. It is intended for use byhealthcare professionals and peoplewith diabetes mellitus at home as anaid in monitoring the effectiveness ofdiabetes control program. It is notintended for the diagnosis of orscreening for diabetes mellitus, and isnot intended for use on neonates.Professionals may use the test stripsto test capillary and venous bloodsamples, but lay user may not testvenous blood samples. | The POPS!® one Blood GlucoseMonitoring System is intended foruse outside the body (in vitrodiagnostic use) in the quantitativemeasurement of glucose in freshcapillary whole blood taken from thefinger. It is intended to be used bypeople with diabetes mellitus at homeas an aid in monitoring theeffectiveness of a diabetes controlprogram.The POPS!® one Blood GlucoseMonitoring System is intended to beused by a single patient and shouldnot be shared. It is not intended forthe diagnosis of, or screening ofdiabetes. It is not intended for use onneonates. |
| Mode of operation | User initiates test on meter, insertstest strip into meter, lances fingerwith lancing device, and places bloodsample on test strip. If test resulttracking is desired, user must do somanually. | User initiates test within app, lancesfinger with integrated lancet andplaces blood sample on the test strip.Recording of test results is donewirelessly and automatically in theapp. |
| Characteristic | Predicate deviceTD-4277 | Proposed devicePOPS!® one |
| Strip preparation | Strips are stored in ahumidity-controlled vial (25-50 strips per vial), user removes one strip from vial and inserts in meter for testing. | Individual strips are sealed in the sensor module with a foil seal to control humidity. User peels back the foil seal for the test site prior to testing, keeping the other strips covered/secure until use. This improves storage integrity of strips and minimizes user interaction with strips. |
| Lancet | Lancet in lancing device is changed out by user resulting in frequent re-use of lancets (increased infection risk and callous formation). | A new sterile lancet is provided in the sensor module with each test site, so users have a new lancet for each test. |
| Software design | Meter software controls the measurement and calculation of blood glucose and displays result on the meter. | Meter software controls the measurement and calculation of blood glucose and transmits the information to the POPS!® app for display and storage of results. |
| Meter Size (mm) | 96 (L) x 61 (W) x 26 (H) | 43 (L) x 39 (W) x 24 (H) |
| Meter Weight (g) | 67.2 g | 13 g |
| Power source | 2 x 1.5V AAA batteries | 1 CR2032 battery |
| User interface | LCD and buttons | Mobile application |
| Display of test results | LCD screen | Mobile application |
| Transmission function | USB | Encrypted and secure Bluetooth |
| Error messages | Error number displayed on LCD screen | Error number translated into text and displayed on App |
| PCB layout | circuit designed for one test site | circuit designed for three test sites |
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Image /page/8/Picture/0 description: The image shows the word "TaiDoc" in gray font above three red hearts. The hearts are evenly spaced and aligned horizontally. The word "TaiDoc" is in a sans-serif font and is larger than the hearts. The overall impression is one of health and well-being.
泰博科技股份有限公司 TaiDoc Technology Corp.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
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Image /page/9/Picture/0 description: The image shows the logo for TaiDoc. The word "TaiDoc" is written in gray at the top of the image. Below the word are three red hearts. At the bottom of the image is the website address, "www.taidoc.com", written in white on a gray background.
Summary of Testing
Non-clinical and clinical studies were conducted to test, verify and validate the performance of the proposed device according to FDA Guidance issued on October 11, 2016: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. Results from these studies show that all performance criteria were met.
Non-Clinical Testing Summary: Design verification and validation testing was performed to ensure that the POPS!® one System met design specifications and requirements. Testing activities included electrical/mechanical safety tests, functional performance tests (precision, linearity, interference, flex studies) as well as disinfection, cleaning, robustness, sterilization, shelf life and transit studies. Software validation was performed for this moderate level of concern device per FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling.
Conclusion
Based on the information provided in this submission, the POPS!® one Blood Glucose Monitoring System has been shown to be substantially equivalent.to the TD-4277 Blood Glucose Monitoring System.
§ 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.