(265 days)
Not Found
No
The device description explicitly states it uses a "known algorithm" based on an electrochemical method, and there is no mention of AI, ML, or related concepts in the document.
No.
This device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating any condition. Its purpose is to provide quantitative measurements of glucose as an aid to monitor the effectiveness of diabetes control.
No.
Explanation: The "Intended Use / Indications for Use" explicitly states that the system "should not be used for the diagnosis of... diabetes". Instead, it serves as "an aid to monitor the effectiveness of diabetes control."
No
The device description explicitly states that the system consists of "test strips," a "hand held blood glucose meter," and "control solution," all of which are hardware components. The software is part of the meter's functionality, but the device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Confidence 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 directly identifies the device as being for "in vitro diagnostic use," which is the definition of an IVD.
N/A
Intended Use / Indications for Use
The Confidence Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The Confidence Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Confidence 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 Confidence Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes or for neonatal use. The Confidence Blood Glucose Test Strips are for use with the Confidence Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The Confidence™ BGMS consists of test strips stored in a vial with desiccant lining, a hand held blood qlucose meter and a control solution. To perform blood glucose test a test strip is removed from the vial and inserted into Confidence™ meter. On inserting the strip meter gets activated and displays a code, user must select a code corresponding to their strip vial using meter's interface, after selecting correct code, meter will be ready to apply sample by showing a droplet on the LCD display. On applying blood on the end of the test strip a countdown starts and meter LCD displays the plasma equivalent value in the blood sample within 10 seconds in mg/dL unit. The user can validate the operation of the system by using provided known algorithm, where generated current is directly proportional to glucose concentration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A system accuracy evaluation was performed by comparing glucose value obtained by trained person using Confidence™ BGMS from finger stick blood of the 265 subjects with the scaled glucose values obtained by FDA cleared reference method (YSI 2300). The study was performed at two sites using three strip lots and eleven meters. The results demonstrated that Confidence™ BGMS is substantially equivalent in its performance with YSI.
An additional user study was performed to demonstrate that lay users could use the Confidence Glucose Monitoring Systems and obtain accurate results. The study was performed by 181 users; they never have used the candidate device before. The results obtained by using candidate device were compared with the scaled glucose values obtained by YSI. The results demonstrated the Confidence™ BGMS is substantially equivalent in lay users' hand to its performance with YSI.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Accuracy Results Relative to YSI Values (Glucose Concentrations Range 60-500 mg/dL):
Percent (and Number ) of meter results that match the YSI reference (N=270):
Within ± 10 mg/dL or ±10%: 74.8% (202/270)
Within ± 10 mg/dL or ±15%: 99.6% (269/270)
Within ±10 mg/dL or ± 20 %: 100% (270/270)
Users Performance Results Relative to YSI Values (Glucose Concentrations Range 60-480 mg/dL):
Percent (and number) of meter results that match YSI reference (N=187):
Within ±10 mg/dL or ± 10 %: 90.4% (169/187)
Within ±15 mg/dL or ± 15 %: 100% (187/187)
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.
Not Found
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).
Not Found
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
August 21, 2018
Applied Biomedical LLC % Jigar Shah mdi Consultants, Inc. 55 Northern Blvd, Suite 200 Great Neck, NY 11021
Re: K173658
Trade/Device Name: Confidence Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 19, 2018 Received: July 20, 2018
Dear Jigar Shah:
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 vou, 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 Part
1
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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K173658
Device Name Confidence Blood Glucose Monitoring System
Indications for Use (Describe)
The Confidence Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The Confidence Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Confidence 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 Confidence Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes or for neonatal use. The Confidence Blood Glucose Test Strips are for use with the Confidence Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
The assigned 510(K) Number: K 173658
1. Submitter's Identification:
APPLIED BIOMEDICAL LLC 1981 E Miraloma Ave, Unit B Placentia, CA 92870 TEL: 714 646 3233 FAX: 714 646 3238 Date Summary Revised: August 16, 2018 Official Correspondent's name: Dr. Zakir Murtaza Ph.D.
2. Name of the Device:
Confidence™ Blood Glucose Monitoring System
3. Common or Usual Name:
Glucose Test System, Over-the-Counter
-
- Predicate Device Information: K150214. OneTouch Verio Flex Blood Glucose Monitoring System
5. Classification:
Confidence™ Blood Glucose Meter and Confidence™ Test Strips are Class II devices (US 21 CFR § 862.1345), Product Code NBW.
6. Device Description:
The Confidence™ BGMS consists of test strips stored in a vial with desiccant lining, a hand held blood qlucose meter and a control solution. To perform blood glucose test a test strip is removed from the vial and inserted into Confidence™ meter. On inserting the strip meter gets activated and displays a code, user must select a code corresponding to their strip vial using meter's interface, after selecting correct code, meter will be ready to apply sample by showing a droplet on the LCD display. On applying blood on the end of the test strip a countdown starts and meter LCD displays the plasma equivalent value in the blood sample within 10 seconds in mg/dL unit. The user can validate the operation of the system by using provided known algorithm, where generated current is directly proportional to glucose concentration.
4
7.
lntended Use:
The Confidence™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip.
The Confidence™Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Confidence™ Blood Glucose Monitoring 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 Confidence™Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The Confidence™ Blood Glucose Test for use with the Confidence™ Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples freshly drawn from the fingertip.
8. Comparison to Predicate Devices:
Predicate Device: a.
OneTouch Verio Flex Blood Glucose Monitoring System,
- b. Predicate Device 510K number and date of cleared K150214 (July 31 2015)
- Predicate Device Comparison Table C.
| Item | Candidate Device
ConfidenceTM
Blood Glucose
Monitoring System | OneTouch Verio Flex Blood Glucose
Monitoring System |
| ------ | ------------------------------------------------------------------------ | -------------------------------------------------------- |
|---|
Similarities
| 510K Issued on
| 510 (k) number | Current Submission | July 31, 2015 |
|---|---|---|
| K173658 | K150214 | |
| Intended/Indications for | ||
| Use | Same | 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. Not to be used for diagnosis | ||
| or screening diabetes or for neonatal use | ||
| Calibration | Same | Plasma Equivalent |
| Measurement technology | Same | Amperometry |
| Sample type | Same | Capillary whole blood |
| Sample sites | Same | Finger Tip |
| Enzyme | Same | GDH-FAD |
| Maximum Altitude | Same | Up to 10,000 feet |
| Buttons | Same | 3 button user input |
| Weight | Same | Approximately 1.7 ounces |
| Auditory Indicator | Same | Yes |
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Differences
| Operating Temperature | 41-104 °F (5-40 °C) | 43°F - 111°F (6°C - 44°C) |
|---|---|---|
| Operating humidity | 10%-85% | 10% - 90% |
| Test range | 50-600 mg/dL | 20-600 mg/dL |
| Sample volume | 1.2 µL | 0.4 µL |
| Hematocrit | 30 – 55 % | 20%-60% |
| Sample Test Time | 10 seconds | 5 seconds |
| Calibration Coding | Manual code input | |
| with date & time (14 & 30 days average) | Non-coding | |
| Memory capacity | 1500 with date & | |
| time (14 & 30 days | ||
| average) | Non (data transfer to remote station) | |
| Size (L x W x H) | 0.88 x 2.28 x 3.15 | |
| inches | 0.63 x 2.05 x 3.39 inches | |
| Power Source | One 3 Volts, 0.2A | |
| (CR2032) battery | Two 1.5 V (AAA) battery | |
| Microprocessor | 16 Bit with 16K | |
| memory | Multichip Module | |
| Display | Segmented | |
| monochrome liquid | ||
| crystal display | Dot matrix thin film transistor color display | |
| Compatible off-meter | ||
| software accessories | PrimosApp | One Touch Diabetes Management Software |
| Alert Alarm | Option to set alerts | |
| for testing time | No Alarm | |
| Remote data storage | No | Yes |
| Controls solution(s) | Single Control | |
| (either Low, Medium | ||
| or High) | Two Controls (Medium and High) | |
| Target Range Indicator | No | Yes |
| Data Download | Yes, USB only | Yes (via USB or Blue tooth) |
| Test Strip | Plastic molded strip | |
| made of palladium | ||
| plated solid copper | ||
| electrodes covered by | ||
| insert & over molding | ||
| with plastic | Metal foil electrodes trapped between layers of | |
| plastic |
Candidate device is similar or very close to the predicate device in its all major claims. The following are main differences between predicate and candidate device.
- The strip of candidate device has palladium plated solid copper electrodes which l. are covered by insert and over molding of plastic, whereas the predicate device has metal foil electrodes trapped between plastic layers.
- II. In the candidate device data can be transfer using a cable whereas predicate device transfer data wirelessly.
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- III. The candidate device has monochrome display with coding whereas predicate has color displav with no coding.
9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The new Applied Biomedical LLC Confidence, a blood glucose monitoring device was verified against users need and intended uses as to fulfill through Design Input requirements.
The subject device demonstrated substantial equivalent performance to the predicate device and YSI. The following standards were used for non-clinical test:
- EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline i) Second Edition (2005).
- ii) EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (2003).
- iii) ISO 14971 Medical devices —Application of risk management to medical devices (2007).
- iv) IEC/EN 60601-1-2 (EMC Testing)
- v) IEC 61010-1-04 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use, Part 1: General Requirements.
- vi) IEC 61010-1 (2nd Edition) Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 1: General Requirements.
- vii) IEC 61010-2-101:04-Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory use - Part 2-101: Particular Requirements for In-Vitro Diagnostic (IVD) Medical Equipment
10. Discussion of Clinical Tests Performed:
A system accuracy evaluation was performed by comparing glucose value obtained by trained person using Confidence™ BGMS from finger stick blood of the 265 subiects with the scaled glucose value obtained by FDA cleared reference method (YSI 2300). The study was performed at two sites using three strip lots and eleven meters. The results demonstrated that Confidence™ BGMS is substantially equivalent in its performance with YSI.
| (Glucose Concentrations Range 60-500 mg/dL) | ||
|---|---|---|
| Percent (and Number ) of meter results that match the YSI reference (N=270) | ||
| Within ± 10 mg/dL or | ||
| ±10% | Within ± 10 mg/dL or | |
| ±15% | Within ±10 mg/dL or | |
| ± 20 % | ||
| 74.8% (202/270) | 99.6% (269/270) | 00% (270/270) |
System Accuracy Results Relative to YSI Values
The Confidence™ BGMS liner regression data relative to YSI reference value was compared with liner regression data of Touch® VerioFlex™ BGMS (Predicate Device) relative to YSI reference value in following table. All values
7
are showing excellent linearity, the slope and R2 are comparable to predicate device, indicating that the Confidence™ BGMS is substantially equivalent to the VerioFlex™ BGMS as per predicate device labeling.
Liner Regression data for Accuracy of Confidence™ BGMS and Predicate Device Relative to YSI Values
| BGMS | Participants | Slope | Intercept | R2 |
|---|---|---|---|---|
| Touch® VerioFlex™ | 300* | 0.99 | 2.61 | 0.99 |
| Confidence™ | 270 | 0.99 | 3.83 | 0.99 |
| *From Product labeling |
A user study was performed to demonstrate that lay users could use the Confidence Glucose Monitoring Systems and obtain accurate results. The study was performed by 181 users; they never have used the candidate device before. The results obtained by using candidate device were compared with the scaled glucose values obtained by YSI. The results demonstrated the Confidence™ BGMS is substantially equivalent in lay users' hand to its performance with YSI.
Users Performance Results Relative to YSI Values (Glucose Concentrations Range 60-480 mg/dL)
| Percent (and number) of meter results that match YSI reference (N=187) | |
|---|---|
| Within ±10 mg/dL or ± 10 % | Within ±15 mg/dL or ± 15 % |
| 90.4% (169/187) | 100% (187/187) |
The linear regression data obtained by user with the Confidence™ BGMS relative to YSI reference value was compared with liner regression data of values obtained by user using Touch® VerioFlex™ BGMS (Predicate Device) relative to YSI are showed in following table. All values are showing excellent linearity, the slope and R2 are comparable with predicate device, indicating that the Confidence™ BGMS is substantially equivalent to the VerioFlex™ BGMS as per predicate device labeling.
Liner Regression data of Confidence™ BGMS and Predicate Device Relative to YSI
| BGMS | Participants | Slope | Intercept | R2 |
|---|---|---|---|---|
| Touch® VerioFlex™ | 172* | 0.99 | 2.98 | 0.98 |
| Confidence™ | 187 | 1.01 | 0.29 | 0.99 |
| *From Product's labeling |
A survey was also conducted using 181 lay users about the instruction to use and steps to perform the test, cleaning and error codes description. The participants had no difficulty to perform the test and understood the instructions about cleaning and error codes.
11. Conclusions:
The Confidence™ Glucose Monitoring Systems is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principal used, to the predicate device, OneTouch Verio Flex Blood Glucose Monitoring System.