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.

Device Description

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)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the NoCoding1 Plus Blood Glucose Monitoring System, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the NoCoding1 Plus BGMS was tested in accordance with ISO 15197, which would define the acceptance criteria for its analytical performance. While specific numerical acceptance criteria from ISO 15197 are not explicitly listed in detail for each test alongside the device's reported performance, the summary consistently states that the device met the acceptance criteria for each test. For tests where specific numerical acceptance criteria are mentioned (e.g., linearity, hematocrit effect), they are presented alongside the observed performance.

Note: The provided text refers to "Primary and Reference criteria" being met for user performance, which likely corresponds to the ISO 15197 accuracy requirements (e.g., within ±15 mg/dL or ±15%).

Acceptance Criteria (from ISO 15197, or implied from context)	Reported Device Performance (NoCoding1 Plus BGMS)
Repeatability Test:	The pooled SD for concentration intervals 1 and 2 were 1.9 and 2.1 mg/dL, respectively (below 5.0 mg/dL). The pooled CV% for concentration intervals 3, 4, and 5 were 2.8%, 2.6%, and 3.2%, respectively (below 5.0%). All three lots met the acceptance criteria.
Intermediate Precision:	The pooled SD for concentration interval 1 was 1.4 mg/dL. The pooled CV for concentration intervals 2 and 3 were 3.0% and 2.4%, respectively. Met the acceptance criteria.
Linearity Test:	Acceptance Criteria: Within ±10 mg/dL for glucose concentrations <100 mg/dL and within 10% for glucose concentrations ≥100 mg/dL. Precision maintained under 5 mg/dL for <100 mg/dL (SD) and 5% for ≥100 mg/dL (CV). Linear correlation coefficient (r²) well above 0.98. Reported Performance: All data points were within ±10 mg/dL for <100 mg/dL and within 10% for ≥100 mg/dL. Precision was maintained under 5 mg/dL (SD) for <100 mg/dL and 5% (CV) for ≥100 mg/dL. Linear correlation coefficients (r²) for all strip lots were well above 0.98.
Hematocrit Effect Test:	Acceptance Criteria: Less than 10 mg/dL bias for glucose <80 mg/dL and less than 10% for glucose >100 mg/dL. Reported Performance: Biases of individual BGMS measurements from YSI were less than 10 mg/dL and 10% below 80 mg/dL and above 100 mg/dL, respectively. No significant interference within 15% to 65% hematocrit levels.
Interference Test:	Acceptance Criteria: No significant effect on glucose measurement from interferents. Reported Performance: The 24 interferents studied showed no effect on glucose measurement at both low and high glucose concentration intervals.
Altitude Test:	Acceptance Criteria: Individual results not showing significant difference (±10%) with respect to reference equipment or different altitudes. Reported Performance: Individual results did not show significant difference (±10%) with respect to the reference equipment, nor with different altitudes at all glucose concentrations. No systematic response to altitudes up to 10,000 feet (3,048m).
Operating Condition Test:	Acceptance Criteria: Individual meter measurements giving less than 10 mg/dL or 10% bias from YSI reference results. Reported Performance: Individual meter measurements gave less than 10 mg/dL or 10% bias from YSI reference results. Operates normally at presented conditions (6°C to 44°C and 10% to 90% RH).
Sample Volume Test:	Acceptance Criteria: Meter bias from YSI within acceptance criteria. Reported Performance: The smallest volume required for accurate measurement was 0.5 uL, and the meter bias from YSI was all within the acceptance criteria.
User Performance (Accuracy):	Acceptance Criteria (implied from meeting "Primary and Reference criteria," likely based on ISO 15197): - For glucose concentration < 75 mg/dL: likely a high percentage within ±5 mg/dL, ±10 mg/dL, etc. - For glucose concentration ≥ 75 mg/dL: likely a high percentage within ±5%, ±10%, etc. Reported Performance: - Glucose < 75 mg/dL (n=41): 61.0% within ±5 mg/dL, 97.6% within ±10 mg/dL, 100% within ±15 mg/dL. - Glucose ≥ 75 mg/dL (n=330): 70.0% within ±5%, 96.1% within ±10%, 100% within ±15%, 100% within ±20%.
User Performance (Usability):	Acceptance Criteria: Users find the device easy to follow and use. Reported Performance: 100% of data met Primary and Reference criteria. More than 100% of subjects gave scores above 3 (neither easy nor difficult) on the questionnaire, confirming the User's Guide is easy to follow and the device is easy to use.

Study Information:

Sample sizes used for the test set and the data provenance:
- Analytical Performance Tests (Repeatability, Intermediate Precision, Linearity, Hematocrit, Interference, Altitude, Operating Condition, Sample Volume): The specific number of individual samples (e.g., blood solutions) tested varies per experiment. For example, linearity involved 9 concentration intervals, tested once with 5 meters per lot across 3 lots. Hematocrit effect involved 3 glucose intervals x 7 hematocrit levels, tested for 3 lots of strips.
- User Performance Study:
  - Test Participants: 371 diabetic and pre-diabetic individuals.
  - Provenance: The study was conducted at "three clinical sites," implying a prospective study. The country of origin is not explicitly stated for the participant data, but the manufacturer is based in Seoul, Korea, so it's likely Korean or a similar demographic.
  - Naive Subjects: Approximately 10% to 15% were "naive subjects" (never exposed to using BGMS on their own).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the analytical performance tests (linearity, hematocrit, interference, altitude, operating condition, sample volume), the ground truth was established by a Yellow Springs Instrument (YSI), which is a laboratory comparator method known for its accuracy in glucose measurement. This is a highly accurate chemical analysis method, not an expert human interpretation.
- For the user performance study, the blood glucose measurements from the NoCoding1 Plus BGMS were compared against an unstated "reference" (likely also a YSI or similar high-accuracy lab method, as implied by other tests and typical BGMS validation). The ground truth was based on these objective reference measurements, not expert human assessment of BGMS readings.
Adjudication method for the test set:
- Not applicable in the traditional sense of image interpretation or clinical diagnosis. The tests involved objective analytical measurements (device reading vs. YSI reference) and user questionnaire responses. There was no mention of human expert adjudication of results for accuracy.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study in the context of diagnostic imaging (which often involves human reader performance with and without AI assistance) was not done. This device is a Blood Glucose Monitoring System, which does not involve human interpretation of complex data for diagnosis in the same way imaging AI does. The user performance study involved users operating the device and comparing its readings to a reference, not human readers interpreting device-generated "cases."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the majority of the analytical performance tests (Repeatability, Intermediate Precision, Linearity, Hematocrit Effect, Interference, Altitude, Operating Condition, Sample Volume Tests) represent standalone performance of the device (meter + strip) without human-in-the-loop decision-making. The measurements are automated, and the results are compared against a laboratory reference standard (YSI).
The type of ground truth used:
- Laboratory Reference Standard: The primary ground truth for all analytical accuracy assessments (Linearity, Hematocrit, Interference, Altitude, Operating Condition, Sample Volume, and the underlying accuracy of Repeatability and Intermediate Precision) was a Yellow Springs Instrument (YSI), described as a "laboratory comparator method."
- For the user performance study, the device's measurements were compared against an unstated "reference" which, given the context, is also likely a YSI or similar high-accuracy laboratory method.
The sample size for the training set:
- The document describes performance testing for regulatory submission (510(k)) and does not mention a training set in the context of machine learning or AI. This is a traditional medical device (blood glucose meter) validation, not an AI/ML-based device that typically requires a large training dataset.
How the ground truth for the training set was established:
- Not applicable, as no training set for an AI/ML algorithm was mentioned or appears to be part of this device's validation.

Summary

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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.

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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/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 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.

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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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 informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
Type of 510(k):	Traditional 510(k)
Submitter Information:	i-SENS, Inc.43, Banpo-daero 28-gil, Seocho-gu, Seoul, KoreaTel.) +82-2-916-6191Fax) +82-2-942-2514e-mail: jhjung@i-sens.comContact 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 862.1345Blood Glucose Test System	Clinical Chemistry 75
CGA	Class II	21 CFR 862.1345Blood Glucose Test System	Clinical Chemistry 75
*JJX	Class I	21 CFR 862.1660Blood 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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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) consistsof a blood glucose meter, single use test strips, and control solutions with twodifferent glucose concentrations (“Control A" and "Control B" ranges).The NoCoding1 Plus BGMS is based on an electrochemical biosensortechnology (electrochemical). The System measures the glucose level inwhole blood samples using a small electrical current generated in the teststrips.The following items are included in the NoCoding1 Plus Blood GlucoseMonitoring 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 areavailable separately.NoCoding1 Glucose Control Solution (cleared in K080923)
Intended Use:	NoCoding1 Plus Blood Glucose Monitoring SystemThe NoCoding1 Plus Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samplesdrawn from the fingertip. The NoCoding1 Plus Blood Glucose MonitoringSystem is intended for self-testing outside the body (for in vitro diagnosticuse) by people with diabetes at home as an aid to monitor the effectivenessof diabetes control. The system is intended to be used by a single person andshould not be shared. It is not intended for use on neonates and is not for thediagnosis or screening of diabetes.The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1Plus Blood Glucose Meters to quantitatively measure glucose in freshcapillary whole blood samples drawn from the fingertip.

Predicate Device

CareSens N Blood Glucose Monitoring System (K083468)

Device Description

The NoCoding1 Plus Blood Glucose Monitoring System (BGMS) consistsof a blood glucose meter, single use test strips, and control solutions with twodifferent glucose concentrations (“Control A" and "Control B" ranges).The NoCoding1 Plus BGMS is based on an electrochemical biosensortechnology (electrochemical). The System measures the glucose level inwhole blood samples using a small electrical current generated in the teststrips.The following items are included in the NoCoding1 Plus Blood GlucoseMonitoring 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 areavailable separately.NoCoding1 Glucose Control Solution (cleared in K080923)

Intended Use:

NoCoding1 Plus Blood Glucose Monitoring SystemThe NoCoding1 Plus Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samplesdrawn from the fingertip. The NoCoding1 Plus Blood Glucose MonitoringSystem is intended for self-testing outside the body (for in vitro diagnosticuse) by people with diabetes at home as an aid to monitor the effectivenessof diabetes control. The system is intended to be used by a single person andshould not be shared. It is not intended for use on neonates and is not for thediagnosis or screening of diabetes.The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1Plus Blood Glucose Meters to quantitatively measure glucose in freshcapillary 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

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i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea

Comparison to the Predicate Device
Characteristic	Predicate DeviceCareSens N Blood Glucose Monitoring System (K083468)	Candidate DeviceNoCoding1 Plus Blood Glucose Monitoring System
Intended Use	The CareSens N Blood Glucose Monitoring System isintended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips andalternative sites such as the forearm, palm, thigh, and calf.Alternative sitetesting should be used only during steady-state blood glucoseconditions. The CareSens N Blood Glucose MonitoringSystem is intended for self- testing outside the body ( in vitro )by people with diabetes as an aid to monitor the effectivenessof diabetes control. It is not intended for use on neonates andis not for the diagnosis or screening of diabetes.	Same with the following difference: No alternative sitetesting
Common name	System, test, blood glucose, over the counter	Same
Test Principle	Electro-chemical reaction. The glucose meter measureselectrical current generated by enzyme using the glucose assubstrate 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	10~90%	Same
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 averagerange	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 (%)	20~60	15~65
Alternate sitecapability	Yes(Testing sites include the traditional fingertip testing alongwith alternate sites testing on forearm, palm, thigh and calf.)	No

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i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea

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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 <100 mg/dL and within 10% for glucose concentrations ≥100 mg/dL. Precision was maintained under 5 mg/dL for glucose concentrations <100 mg/dL (SD values) and 5 % for concentrations ≥100 mg/dL (CV values). The linear correlation coefficients (r2) for all strip lots were well above the acceptance criteria of 0.98. within the measured range of 13.1 to 614 mg/dL, over the specification of the measuring range, the performance of test strips has been confirmed to be linear.

Hematocrit Effect Test

Seven different hematocrit levels were tested to evaluate the effect of hematocrit level on measurement of glucose concentration. Each of three different glucose intervals is prepared in seven different hematocrit levels. Three concentration levels of blood samples at seven hematocrit levels were tested for three lots of test strips. For all of the 21 samples, the biases of individual BGMS measurements from YSI were less than 10 mg/dL and 10% below 80 mg/dL and above 100 mg/dL respectively. Hence it has been confirmed that NoCoding1 Plus BGMS has no significant interference within 15 % to 65 % hematocrit levels.

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Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax

Interference Test

Interference test results have shown that the 24 interferents studied (acetaminophen, ascorbic acid, bilirubin, cholesterol, creatinine, dopamine, EDTA, galactose, gentisic acid, glutathione (Red), hemoglobin, heparin, ibuprofen, icodextrin, L-dopa, maltose, methyldopa, pralidoxime iodide, salicylate, tolbutamide, triglycerides, uric acid and xylose) at significantly high levels have no effect on glucose measurement by NoCoding1 Plus BGMS. The results obtained from the primary tests were sufficient to show non-significance of the presence of these interferents at both low and high glucose concentration intervals. Thus it can be concluded that NoCoding1 Plus BGMS is safe to use for blood glucose monitoring even in the presence of the 24 substances studied.

Altitude Test

Altitude testing is performed inside an altitude chamber where various altitudes are simulated by manipulating the atmospheric pressure inside the chamber. Individual results from NoCoding1 Plus BGMS did not show significant difference (± 10 %) with respect to the reference equipment, nor with different altitudes at all glucose concentrations. Hence it was confirmed that our BGMS has no systematic response to altitudes and is not significantly affected by lack of atmospheric oxygen up to 10,000 feet (3,048m) above the sea level.

Operating Condition Test

The operating conditions of NoCoding1 Plus BGMS are within 6C to 44C and 10 % to 90 % (RH). The test is conducted at 9 different combined temperature and humidity conditions. By evaluating measurement difference from the condition 5 (23℃, 40%) & individual meter value compared to YSI, the performance of NoCoding1 Plus BGMS is demonstrated to be uniformly accurate throughout the actual conditions of use. Operating condition test was conducted at 9 combined temperature-humidity conditions of 6 °℃ and 44 °C at 10%, 40% and 90% RH. We have confirmed that NoCoding1 Plus BGMS operates normally at the presented conditions, individual meter measurements giving less than 10 mg/dL or 10 % bias from YSI reference results.

Sample volume Test

Minimum sample volume for accurate glucose measurement was determined by testing with whole blood samples. Sample volume test was performed using whole blood samples from 3 subjects, each divided into hypoglycemic, euglycemic and hyperglycemic concentrations. When 0.4 uL of sample was applied to the strip, Er 4 messages appeared. The smallest volume required for accurate measurement of NoCoding1 Plus BGMS was 0.5 uL, and the meter bias from YSI were all within the acceptance criteria.

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Image /page/10/Picture/0 description: The image shows the logo for i-sens. The logo is blue, except for a green dot above the "i". The text is sans-serif and bolded.

i-SENS. Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

User Performance

In this study, diabetic and pre-diabetic people from various backgrounds have participated in the user performance test of NoCoding1 Plus BGMS. The study is monitored at three clinical sites against a total of 371 test participants. Approximately ten percent of (10%) but no more than fifteen percent (15%) of naïve subjects have participated in the study. The measurement results have demonstrated that 100 % of data have met the Primary and Reference criteria. Test subjects varied in gender, age and highest level of education, and regardless of the backgrounds, more than 100% of subjects had given scores above 3 (neither easy nor difficult) on the questionnaire. While few of the test subjects were prediabetic and were never exposed to using BGMS on their own, the test results confirm that the instruction given in the User's Guide of NoCoding1 Plus BGMS is easy to follow and that it is easy to use for blood glucose testing.

Site	n	Within± 5 mg/dL	Within± 10 mg/dL	Within± 15 mg/dL
Combined	41	61.0%(25/41)	97.6%(40/41)	100%(41/41)

Accuracy results for glucose concentration < 75 mg/dL

Accuracy results for glucose concentration ≥ 75 mg/dL

Site	n	Within±5%	Within± 10 %	Within± 15 %	Within±20%
Combined	330	70.0%(231/330)	96.1%(317/330)	100%(330/330)	100%(330/330)

Linear regression analysis

Site	Slope	Intercept	R2	N	GlucoseConcentration range(new meter) (mg/dL)
Combined	1.0223	-1.3686	0.9934	371	48~553

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Image /page/11/Picture/0 description: The image shows the logo for i-sens. The logo is blue, except for two green dots that are part of the "i". The text is sans-serif and 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

Summary of Pre-cleaning and Disinfection

The device is intended for single patient home use. Disinfection studies were performed on the meter and lancing device by an outside commercial testing service to evaluate effectiveness of disinfectant, CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12), in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). The results demonstrated complete inactivation of live virus inoculated on the mater and lancing device. We have also demonstrated that 10,950 each of pre-cleaning and disinfection cycles for meter with the same disinfectant designed to simulate 3 years of multiple-patient use or 5 years (260 each of pre-cleaning and disinfection cycles for meter and lancing device) of single patient device use has no effect on the performance or the external materials of the meter and lancing device.

Data demonstrating The candidate device was tested in accordance with ISO 15197. Analytical performance testing included system accuracy, repeatability, and intermediate substantial equivalence precision testing. A user performance evaluation assessed accuracy of results and usability of the device in the hands of intended users. The candidate device performed similarly to both the predicate device as well as to a laboratory comparator method, the Yellow Springs Instrument (YSI). All testing demonstrated safety and effectiveness of the candidate device and substantial equivalence to the predicate device. Therefore, there are no substantive differences between the products defined in this 510(k) submission and the predicate device.
Based on the submitted information in this premarket notification, the candidate Conclusion devices are substantially equivalent to the predicate device. Further, the candidate devices have met the performance, safety, and effectiveness of the device for its intended use.

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.