(274 days)
No
The description focuses on electrochemical biosensor technology and standard performance metrics for a blood glucose meter. There is no mention of AI, ML, or related concepts.
No
Explanation: This device is for diagnostic purposes, intended to measure glucose levels for monitoring diabetes, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is "intended for the quantitative measurement of glucose" and "for in vitro diagnostic use." It also notes it is "an aid to monitor the effectiveness of diabetes control," which implies a diagnostic or monitoring function. Although it explicitly states "not for the diagnosis or screening of diabetes," it does provide quantitative measurements that are used to monitor a health condition, which falls under the broader definition of a diagnostic device.
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The NoCoding1 Plus Blood Glucose Monitoring System is intended for self-testing outside the body (for in vitro diagnostic use)..."
This statement directly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The NoCoding1 Plus Blood Glucose Monitoring System is intended for self-testing outside the body (for in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The NoCoding1 Glucose Control Solutions are for use with the NoCoding1 Plus Blood Glucose Meters and NoCoding1 Blood Glucose Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
Product codes
NBW, CGA, JJX
Device Description
The NoCoding1 Plus Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations (“Control A" and "Control B" ranges). The NoCoding1 Plus BGMS is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips.
The following items are included in the NoCoding1 Plus Blood Glucose Monitoring system:
- 1 NoCoding1 Plus Blood Glucose Meter
- 10 NoCoding1 Blood Glucose Test Strips
- 1 Lancing device
- 10 Lancets
- 1 Owner's Booklet
- 1 Quick Reference Guide
- 2 Batteries (3.0V lithium batteries)
The following items are compatible with the NoCoding1 Plus BGMS and are available separately.
NoCoding1 Glucose Control Solution (cleared in K080923)
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 intended for use on neonates.
Intended User / Care Setting
self-testing outside the body (for 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
Repeatability Test: The repeatability of NoCoding1 Plus BGMS was evaluated using whole blood spiked with glucose at five concentration intervals. Blood glucose is measured by the same user, same meters and same strip lots in one day. The repeatability is evaluated for a total of 5 concentration intervals using 10 meters per lot and 3 lots of test strips. The pooled SD of concentration intervals 1 and 2 were 1.9 and 2.1 mg/dL, respectively that were below 5.0 mg/dL. The pooled CV % of concentration intervals 3, 4 and 5 were 2.8, 2.6 and 3.2 %, respectively that were below 5.0 %. All three lots met the acceptance criteria of the repeatability test in all concentration intervals.
Intermediate Precision: Intermediate precision was performed using control solution with 10 operators. Three lots of test strips were evaluated. Glucose testing was conducted by every operator using 3 levels of control solutions for a minimum of 10 days. The pooled SD of concentration interval 1 was 1.4 mg/dL and the pooled CV of concentration intervals 2 and 3 were 3.0 %, 2.4 % respectively. NoCoding 1 Plus have met the acceptance criteria of intermediate precision requirements.
Linearity Test: The linearity of NoCoding1 Plus BGMS was evaluated using whole blood spiked with glucose. Linearity is evaluated for a total of 9 concentration intervals using 5 meters per lot and 3 lots of test strips. Each meter is tested once with each concentration. Three lots of test strips were tested to confirm linearity of NoCoding1 Plus BGMS throughout its measuring range of 20 to 600 mg/dL. All data points are within ±10 mg/dL for glucose concentrations
§ 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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol of medicine, with three lines representing the wings and a snake winding around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2016
I-SENS, INC. JOON HO JUNG RA TEAM MANAGER 43, BANPO-DAER0 28-GIL, SEOCHO-GU SEOUL 06646 KR
Re: K160742
Trade/Device Name: NoCoding1 Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: November 18, 2016 Received: November 29, 2016
Dear Mr. Joon Ho Jung:
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 (OS) 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/ResourcesforYou/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,
Courtney
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) K160742
Device Name
NoCoding1 Plus Blood Glucose Monitoring System
Indications for Use (Describe)
The NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The NoCoding1 Plus Blood Glucose Monitoring System is intended for self-testing outside the body (for in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The NoCoding1 Glucose Control Solutions are for use with the NoCoding1 Plus Blood Glucose Meters and NoCoding1 Blood Glucose Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
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 i-sens. The "i" is blue with a green dot above it. The rest of the word, "sens", is in blue.
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
510(k) Summary
(As required by 21 CFR 807.92) K160742
| Introduction: | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k): | Traditional 510(k) |
| Submitter Information: | i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea
Tel.) +82-2-916-6191
Fax) +82-2-942-2514
e-mail: jhjung@i-sens.com
Contact Person: Joon Ho Jung |
| Prepared Date: | December 12th, 2016 |
Device Name and Trade names: NoCoding1 Plus Blood Glucose Monitoring System Common name: Blood Glucose Test System Classification
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW | Class II | 21 CFR 862.1345 | |
| Blood Glucose Test System | Clinical Chemistry 75 | ||
| CGA | Class II | 21 CFR 862.1345 | |
| Blood Glucose Test System | Clinical Chemistry 75 | ||
| *JJX | Class I | 21 CFR 862.1660 | |
| Blood Glucose Test System | Clinical Chemistry |
*Regulatory approval Control solution has been cleared under K080923, CareSens Blood Glucose Monitoring System. The CareSens BGMS is manufactured by i-SENS, and has the same technological principals as to the candidate device. CareSens control solution is exactly the same as the NoCoding1 control solution in exception to the brand name. Both control solution has the exact same manufacturing process, and chemical formulation & composition.
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Image /page/4/Picture/0 description: The image shows the logo for i-sens. The logo is blue, except for the dot over the "i", which is green. The text is sans-serif and bolded.
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea
| Predicate Device | CareSens N Blood Glucose Monitoring System (K083468) |
|---|---|
| Device Description | The NoCoding1 Plus Blood Glucose Monitoring System (BGMS) consists |
| of a blood glucose meter, single use test strips, and control solutions with two | |
| different glucose concentrations (“Control A" and "Control B" ranges). | |
| The NoCoding1 Plus BGMS is based on an electrochemical biosensor | |
| technology (electrochemical). The System measures the glucose level in | |
| whole blood samples using a small electrical current generated in the test | |
| strips. | |
| The following items are included in the NoCoding1 Plus Blood Glucose | |
| Monitoring system: |
- 1 NoCoding1 Plus Blood Glucose Meter
- 10 NoCoding1 Blood Glucose Test Strips
- 1 Lancing device
- 10 Lancets
- 1 Owner's Booklet
- 1 Quick Reference Guide
- 2 Batteries (3.0V lithium batteries)
The following items are compatible with the NoCoding1 Plus BGMS and are
available separately.
NoCoding1 Glucose Control Solution (cleared in K080923) |
| Intended Use: | NoCoding1 Plus Blood Glucose Monitoring System
The NoCoding1 Plus Blood Glucose Monitoring System is intended for the
quantitative measurement of glucose in fresh capillary whole blood samples
drawn from the fingertip. The NoCoding1 Plus Blood Glucose Monitoring
System is intended for self-testing outside the body (for in vitro diagnostic
use) by people with diabetes at home as an aid to monitor the effectiveness
of diabetes control. The system is intended to be used by a single person and
should not be shared. It is not intended for use on neonates and is not for the
diagnosis or screening of diabetes.
The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1
Plus Blood Glucose Meters to quantitatively measure glucose in fresh
capillary whole blood samples drawn from the fingertip. |
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Image /page/5/Picture/0 description: The image shows the logo for i-sens. The "i" is blue with a green dot above it. The rest of the word, "sens", is also in blue. The logo is simple and modern.
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
The NoCoding1 Glucose Control Solutions are for use with the NoCoding1 Plus Blood Glucose Meters and NoCoding1 Blood Glucose Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
6
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea
| Comparison to the Predicate Device | ||
|---|---|---|
| Characteristic | Predicate Device | |
| CareSens N Blood Glucose Monitoring System (K083468) | Candidate Device | |
| NoCoding1 Plus Blood Glucose Monitoring System | ||
| Intended Use | The CareSens N Blood Glucose Monitoring System is | |
| intended for the quantitative measurement of glucose in fresh | ||
| capillary whole blood samples drawn from the fingertips and | ||
| alternative sites such as the forearm, palm, thigh, and calf. | ||
| Alternative site | ||
| testing should be used only during steady-state blood glucose | ||
| conditions. The CareSens N Blood Glucose Monitoring | ||
| System is intended for self- testing outside the body ( in vitro ) | ||
| by people with diabetes as an aid to monitor the effectiveness | ||
| of diabetes control. It is not intended for use on neonates and | ||
| is not for the diagnosis or screening of diabetes. | Same with the following difference: No alternative site | |
| testing | ||
| Common name | System, test, blood glucose, over the counter | Same |
| Test Principle | Electro-chemical reaction. The glucose meter measures | |
| electrical current generated by enzyme using the glucose as | ||
| substrate in sample. | Same | |
| Enzyme | Glucose Oxidase |
- Glucose Oxidase (Aspergillus sp.): 2.7 units
- Hexaamineruthenium(III) chloride: 45.7 $μ$ g
- Other ingredients: 1.6 $μ$ g | Same |
| Measurement Principle | Amperometric method | Same |
| Sample type | Fresh capillary whole blood | Same |
| Calibration | Plasma-equivalent | Same |
| Coding system | No coding required (Automatic code identification) | Same |
| Test time (sec.) | 5 | Same |
| Sample volume (ul) | 0.5 | Same |
| Measurement unit | mg/dL | Same |
| Test range (mg/dL) | 20-600 | Same |
| Operating Humidity | 1090% | Same |60 | 15~65 |
| Control Levels | Two Levels | Same |
| Power Source | Two 3.0V lithium batteries (CR2032) | Same |
| Differences | | |
| Memory capacity | Up to 250 test results | Up to 1,000 test results |
| Test result average
range | 14 days (Pre-meal, Post-meal, and Total) | 1, 7,14, 30 and 90 days
(Pre-meal, Post-meal, Fasting and Total) |
| Operating Temperature | 50 - 104 °F | 42.8-111.2°F |
| Hematocrit range (%) | 20
| Alternate site
capability | Yes
(Testing sites include the traditional fingertip testing along
with alternate sites testing on forearm, palm, thigh and calf.) | No |
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Image /page/7/Picture/0 description: The image shows the logo for i-sens. The logo is blue with a green dot above the i and a green dot in the middle of the i. The text is sans-serif and the dots are circular.
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea
8
Image /page/8/Picture/0 description: The image shows the i-sens logo. The logo is blue, except for two green dots. The first green dot is above the "i" and the second green dot is in the middle of the "i".
- Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2
Performance Test Summary
Repeatability Test
The repeatability of NoCoding1 Plus BGMS was evaluated using whole blood spiked with glucose at five concentration intervals. Blood glucose is measured by the same user, same meters and same strip lots in one day. The repeatability is evaluated for a total of 5 concentration intervals using 10 meters per lot and 3 lots of test strips. The pooled SD of concentration intervals 1 and 2 were 1.9 and 2.1 mg/dL, respectively that were below 5.0 mg/dL. The pooled CV % of concentration intervals 3, 4 and 5 were 2.8, 2.6 and 3.2 %, respectively that were below 5.0 %. All three lots met the acceptance criteria of the repeatability test in all concentration intervals.
Intermediate Precision
Intermediate precision was performed using control solution with 10 operators. Three lots of test strips were evaluated. Glucose testing was conducted by every operator using 3 levels of control solutions for a minimum of 10 days. The pooled SD of concentration interval 1 was 1.4 mg/dL and the pooled CV of concentration intervals 2 and 3 were 3.0 %, 2.4 % respectively. NoCoding 1 Plus have met the acceptance criteria of intermediate precision requirements.
Linearity Test
The linearity of NoCoding1 Plus BGMS was evaluated using whole blood spiked with glucose. Linearity is evaluated for a total of 9 concentration intervals using 5 meters per lot and 3 lots of test strips. Each meter is tested once with each concentration. Three lots of test strips were tested to confirm linearity of NoCoding1 Plus BGMS throughout its measuring range of 20 to 600 mg/dL. All data points are within ±10 mg/dL for glucose concentrations