UniStrip1 Generic Blood Glucose Test Strips

K162430 · Ok Biotech Co., Ltd. · NBW · Jan 19, 2017 · Clinical Chemistry

Device Facts

• Record ID: K162430
• Device Name: UniStrip1 Generic Blood Glucose Test Strips
• Applicant: Ok Biotech Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®2, OneTouch®, UltraMini® and OneTouch®, UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control. They are for single patient use only and should not be shared. They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use). They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®, Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).

Device Story

UniStrip1 Generic Blood Glucose Test Strips are single-use, in vitro diagnostic strips used with specific LifeScan OneTouch Ultra meters (purchased before April 2016) set to calibration code 49. The device utilizes a glucose oxidase amperometric assay; capillary blood (1.0 μL) is applied to the strip; glucose reacts with the enzyme to generate an electrical current proportional to glucose concentration. The meter measures this current and displays the result. Used by patients with diabetes at home for monitoring glucose levels; results assist in diabetes management. The device supports alternate site testing (fingertip, palm, forearm) during steady-state glucose conditions. Healthcare providers use the displayed results to evaluate the effectiveness of a patient's diabetes control regimen.

Clinical Evidence

Performance evaluated via a 100-participant lay-user study comparing fingerstick and forearm capillary blood results against YSI-2300 reference values. Results showed 100% of fingerstick and forearm samples were within ±15% of reference values for glucose ≥75 mg/dL. Bench testing included precision (CV 1.8-3.9%), linearity (R² > 0.99), and interference testing for various substances. No clinical diagnostic data provided; study focused on analytical performance and user-readability.

Technological Characteristics

Amperometric glucose oxidase (Aspergillus niger) biosensor. Materials include PET substrate. Dimensions/form factor: test strip. Connectivity: compatible with specific legacy OneTouch meters. Calibration: code 49. Operating range: 6-44°C, 10-90% RH. Sample volume: 1.0-1.5 µL.

Indications for Use

Indicated for people with diabetes for home self-testing of capillary whole blood glucose as an aid to monitor diabetes control. Not for diagnosis, screening, or neonatal use. Contraindicated for use in critically ill patients, patients with severe dehydration, shock, hyperosmolar state, or those undergoing oxygen therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• UniStrip1 Generic Blood Glucose Test Strips (k160038)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem that appears to be a stylized representation of three human profiles facing to the right, possibly symbolizing health, humanity, and service.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

OK BIOTECH CO., LTD. KE-MIN JEN, OFFICIAL CORRESPONDENT NO.91, SEC.2 GONGDAO 5TH ROAD HSINCHU CITY 30070, TAIWAN

January 19, 2017

Re: K162430

Trade/Device Name: UniStrip1™ Generic Blood Glucose Test Strips Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: December 6, 2016 Received: December 15, 2016

Dear Ke-Min Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Katherine Serrano -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K162430

### Device Name

UniStrip1TM Generic Blood Glucose Test Strips

### Indications for Use (Describe)

The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®2, OneTouch®, UltraMini® and OneTouch®, UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.

They are for single patient use only and should not be shared.

They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).

They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®, Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

1 Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/0 description: The image shows a logo for Kbiotech. The logo features a stylized letter "K" with a circle around it, followed by the word "biotech" in a bold, sans-serif font. Below the word "biotech" is some text in a different language, possibly Chinese or Japanese. The logo is simple and modern, and the use of the letter "K" and the word "biotech" suggests that the company is involved in the biotechnology industry.

| 5. 510(k) Summary of Safety and Effectiveness<br>(Per 21 CFR 807.92) | |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type Of 510(K) Submission | Traditional |
| Basis for the submission | Additional or Expanded Indications |
| Common Name Of the Proposed Device | BLOOD GLUCOSE TEST STRIPS |
| Trade name | UniStrip1 Generic Blood Glucose Test Strips |
| 510(k) Submitter | OK BIOTECH CO., LTD.<br>No. 91, Sec. 2, Gongdao 5th Road, 30070,<br>Hsinchu City, Taiwan<br>Telephone: [phone]<br>Fax:[phone]<br>Email: [e-mail] |
| Date prepared | December 6, 2016 |
| Official Correspondent | Dr. Jen, Ke-min<br>TEL: [phone] FAX: [phone]<br>Email: [e-mail] |
| Preference For Continued | 510(k) Summary |
| Confidentiality (21 CFR 807.95) | |
| Device Classification Name | System, Test, Blood Glucose, Over The Counter |
| Regulation Description | Glucose test system |
| Review Panel | Clinical Chemistry |
| Product Code | NBW, CGA |
| Regulation number | 21 CFR 862.1345 |
| Class | 2 |
| Predicate Device | OK Biotech Co., ltd.<br><i>UniStrip1TM Generic Blood Glucose Test Strips</i><br>K160038 |

#### 리 트레 t Cofet -----E FAQULI C

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Image /page/4/Picture/0 description: The image shows a logo for Kbiotech. The logo features a stylized letter K with a circular design around it. The word "biotech" is written in bold, italicized letters next to the K. Below the word "biotech" is some text in a different language.

#### ● Indications for Use:

The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®, OneTouch Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.

They are for single patient use only and should not be shared.

They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).

They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The UniStrip1™ Generic Blood Glucose Test Strips allow alternative site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch® Ultra® meter). Alternate site testing should only be done during steady-state times (when glucose is not changing rapidly).

#### Device Description: ●

The UniStripl Generic Blood Glucose Test Strips are used with the OneTouch® Ultra, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters. The UniStrip1 Generic Blood Glucose Test Strips are intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The UniStrip1 Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch* Ultra* meter). The UniStrip1 Generic Blood Glucose Test Strips can only be used with the OneTouch® Ultra®, OneTouch Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016. UniStripl Generic Blood Glucose Test Strips are only for use with calibration code 49.

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Image /page/5/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter "K" enclosed in a circular shape, followed by the word "biotech" in a bold, sans-serif font. Below the word "biotech" is some text in a different language, possibly Chinese or Japanese.

#### ● Test Principle

The OneTouch® Ultra® Family meters are plasma-calibrated to allow easy comparison of results with laboratory methods. Glucose in the blood sample mixes with special chemicals on the UniStrip1 Generic Blood Glucose Test Strips and a small electrical current is produced. This current is measured by the OneTouch® Ultra® Family Meters and displayed as your blood glucose result. The strength of the current changes with the amount of glucose in the blood sample.

#### ● Comparison Table

| Item | Predicate device | Subject device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | UniStrip1 Generic Blood Glucose<br>Test Strips | UniStrip1 Generic Blood Glucose<br>Test Strips |
| Manufacturer | OK Biotech Co., Ltd. | OK Biotech Co., Ltd. |
| 510(k) No. | K160038 | K162430 |
| Similarities | | |
| Test Principle | Glucose in the blood sample mixes<br>with glucose oxidase on the<br>UniStrip1 test strip and a small<br>electrical current is measured by the<br>meter(s) and displayed as your blood<br>glucose results. The strength of this<br>current changes with the amounts of<br>glucose in the blood sample. | Same |
| Enzyme | Glucose oxidase ( <i>Aspergillus niger</i> ) | Same |
| Specimen Type | Capillary whole blood from fingertip<br>and alternate sites (palm, forearm and<br>upper-arm)<br>(Use of palm AST is not to be done with<br>OneTouch® Ultra® meter). | Same |
| Sample Volume | 1.0 μL | Same |
| Operating<br>Temperature | 43 - 111 °F (6 - 44 °C) | Same |
| Temperature | 10 - 90% R.H. | Same |
| HCT Range | 30 - 55% | Same |
| Detecting Limit | 20 - 600 mg/dL | Same |
| Measuring time | 5 seconds | Same |
| Strip Storage<br>Temperature | 39 - 104 °F (4 - 40 °C) | Same |
| Opened test strips<br>vial shelf life | 90 days after first opening | Same |
| Unopened test strips<br>vial shelf life | 24 months | Same |
| Brand name of<br>Control solution | UniStrip Control Solutions | Same |
| Ingredient<br>Chemicals of the<br>UniStrip1 Generic<br>Blood Glucose Test<br>Strips | 1. Glucose oxidase (Aspergillus<br>niger): 20 IU<br>2. Potassium ferricyanide: 0.12 mg<br>3. Non-reactive ingredients: 1.8 mg | Same |
| Ingredient<br>Chemicals of the<br>Control Solutions | 1. D-Glucose<br>2. Polyvinyl acetate (aqueous<br>emulsion): 10%<br>3. Antifoaming agent<br>(Polyethylene Glycol 4000):<br>0.02%<br>4. Disodium EDTA: 0.1%<br>5. Fumed silica: 0.2%<br>6. Food Pigment Red No.6:<br>0.05%<br>7. Sodium Benzoate: 0.2% | Same |
| Differences | | |
| Indications for Use | The UniStrip1™ Generic Blood<br>Glucose Test Strips are used with the<br>OneTouch® Ultra®2, OneTouch®<br>UltraMini® and OneTouch®<br>UltraSmart® meters purchased<br>before April 2016, and OneTouch® | The UniStrip1™ Generic Blood<br>Glucose Test Strips are used with<br>the OneTouch® Ultra®, OneTouch<br>Ultra®2, OneTouch® UltraMini®<br>and OneTouch® UltraSmart®<br>meters purchased before April |
| Ultra® purchased before October<br><b>2012</b> , set at calibration code 49, for<br>measuring glucose (sugar) in whole<br>capillary blood. The strips are meant<br>for self-testing of blood glucose as<br>an aid to monitor the effectiveness of<br>diabetes control.<br>They are for single patient use only<br>and should not be shared.<br>They are used to quantitatively<br>measure glucose in fresh capillary<br>whole blood samples taken from the<br>finger, palm, or forearm. Testing<br>is done outside the body (in vitro<br>diagnostic use).<br>They are indicated for use by people<br>with diabetes in their home as an aid<br>to monitor the effectiveness of<br>diabetes control.<br>Not intended for the diagnosis of or<br>screening for diabetes mellitus and is<br>not intended for use on neonates.<br>The UniStrip1™ Generic Blood<br>Glucose Test Strips allow alternate<br>site testing (AST) from the fingertip,<br>palm and/or the forearm. (Use of<br>palm AST is not to be done with<br>OneTouch® Ultra® meter).<br>Alternative site testing should only<br>be done during steady-state times<br>(when glucose is not changing<br>rapidly). | <b>2016</b> , set at calibration code 49,<br>for measuring glucose (sugar) in<br>whole capillary blood. The strips<br>are meant for self-testing of<br>blood glucose as an aid to<br>monitor the effectiveness of<br>diabetes control.<br>They are for single patient use<br>only and should not be shared.<br>They are used to quantitatively<br>measure glucose in fresh<br>capillary whole blood samples<br>taken from the finger, palm, or<br>forearm. Testing is done<br>outside the body (in vitro<br>diagnostic use).<br>They are indicated for use by<br>people with diabetes in their<br>home as an aid to monitor the<br>effectiveness of diabetes control.<br>Not intended for the diagnosis of<br>or screening for diabetes mellitus<br>and is not intended for use on<br>neonates.<br>The UniStrip1™ Generic Blood<br>Glucose Test Strips allow<br>alternate site testing (AST) from<br>the fingertip, palm and/or the<br>forearm. (Use of palm AST is not<br>to be done with OneTouch®<br>Ultra® meter). Alternative site<br>testing should only be done<br>during steady-state times (when<br>glucose is not changing rapidly). | |

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Image /page/6/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K inside of an oval shape. The text "Kbiotech" is written in a stylized font to the right of the K symbol, and below that is some text in another language.

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Image /page/7/Picture/0 description: The image shows a logo with the letter K in a stylized font. Next to the K is the word "biotech" in a bold, sans-serif font. Below the logo is text in a smaller font, which appears to be in Chinese. The logo is likely for a biotechnology company.

E-mail:[e-mail]

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Image /page/8/Picture/0 description: The image shows a logo with the letter K inside of a circle. Next to the logo is the word "biotech" in a stylized font. Below the logo and the word is some text in a different language.

#### ● Substantial Equivalence Discussions

A claim of substantial equivalence is made to UniStrip1 Generic Blood Glucose Test Strips (K160038) made by OK Biotech Co., Ltd. Both devices actually are identical ones, except for the differences of valid dates for the OneTouch® Ultra® meters purchased before April 2012 and purchased before April 2016. This 4-year extra valid period for the OneTouch® Ultra® meter has been validated by conducting the performance testing on the OneTouch® Ultra® meters, The difference of validated dates for the OneTouch® Ultra® meters will not raise any safety or effectiveness concerns. They are substantially equivalent.

#### ● Summary of Performance Tests and Non-Clinical Studies

The following tests and studies were conducted to ensure the subject device, UniStripl Generic Blood Glucose Test Strips, used with the following blood glucose meters: OneTouch Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and One-Touch® UltraSmart® meters purchased before April 2016 were safe and effective in measuring blood glucose concentration.

- 1. Altitude study per ISO 15197:2013 In vitro diagnostic test systems -Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus
The study shows the individual bias fall within ± 10 % at the altitude from 298 feet (91 meters) to 11,161 feet (3,402 meters). The Standard Deviations (SD) at blood glucose concentration < 100 mg/dL and CV at the blood glucose concentration ≥ 100 mg/dL for the measurements were less than 5.0 mg/dL and 5.0 %, respectively. The results meet the acceptance criteria. So it shows no significant effects on the UniStrip1 Generic Blood Glucose Test Strips with OneTouch® Ultra® Meters at various altitudes from 298 feet to 11,161 feet (91 to 3,402 meters). We claim that it can be used up to 10,000 ft.

- 2. Hematocrit study per ISO 15197:2013 In vitro diagnostic test systems -Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus
According to the data, when blood sample with HCT from 30 % to 55 %, (1) All of SD and CV were less than 5 mg/dL and 5% in this study, respectively. (2) All of the individual bias of glucose measurement compared with YSI mean was less than

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Image /page/9/Picture/0 description: The image shows a logo with the letter K in a stylized font. Next to the K is the word "biotech" in a bold, sans-serif font. Below the word "biotech" are Chinese characters. The logo appears to be for a company or organization related to biotechnology.

E-mail:[e-mail]

15%. Also, (3) The Mean Bias% to YSI for each sample of blood glucose concentration at each hematocrit level was less than 10%. (4) The Difference % between the mean glucose bias and the mean bias of the mid-level sample (Hct: 42%) was less than 10%. The test results met the acceptance criteria. In summary, the HCT ranges from 30% to 55% were available for UniStrip1 Generic Blood Glucose Test Strips with OneTouch® Ultra® Meters.

- 3. Interference study per ISO 15197:2013 In vitro diagnostic test systems -Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus and per NCCLS/CLSI EP07-A2:2007 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (FDA recognition number 7-127)
According to the data, all the bias of test results within the range listed above were ≤ 10% compared with the measurements of the controlled pool. Based on the results, the concentration limits of all the interfering substances were higher than therapeutic or physiological levels. That is, no obvious interference was observed in the interfering substance at neither therapeutic nor physiological levels at two blood glucose levels.

- 4. Linearity study per NCCLS/CLSI EP6-A:2014 Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (FDA recognition number 7-193)
According to our test results, the correlation coefficient is greater than 0.95. That is, our test results were highly correlated with YSI 2300. The linearity is available from 20 to 600 mg/dL. 100 % of the bias of individual glucose results fall within ± 10 mg/dL at glucose concentration < 100 mg/dL, and 10% at glucose concentration ≥ 100 mg/dL compared with Glucose Analyzer YSI 2300. The test results shown in the following table met the acceptance criteria

| Strips lots | Slope | Intercept | R2 | r |
|-------------|--------|-----------|--------|---------|
| Lot I | 0.994 | -1.0434 | 0.9988 | 0.9994 |
| Lot II | 1.0037 | 0.6514 | 0.9985 | 0.99925 |
| Lot III | 1.0039 | 0.389 | 0.9991 | 0.99955 |

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Image /page/10/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K with a circle around it, followed by the word "biotech" in a smalle…