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 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.

AI/ML Overview

The provided text details various studies and their acceptance criteria for the UniStrip1™ Generic Blood Glucose Test Strips. This device is intended for self-testing of blood glucose with several OneTouch® Ultra® meters.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Study/Test	Acceptance Criteria	Reported Device Performance
Altitude Study	Individual bias within ±10% at altitudes from 298 feet (91 meters) to 11,161 feet (3,402 meters). SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL.	Individual bias fell within ±10% from 298 feet (91 meters) to 11,161 feet (3,402 meters). SD < 5.0 mg/dL and CV < 5.0% for specified glucose concentrations. Claimed usability up to 10,000 ft.
Hematocrit Study	(1) All SD and CV < 5 mg/dL and 5% respectively. (2) All individual bias of glucose measurement vs YSI mean < 15%. (3) Mean Bias% to YSI for each sample < 10%. (4) Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%.	(1) All SD and CV were less than 5 mg/dL and 5% respectively. (2) All individual bias of glucose measurement vs YSI mean was less than 15%. (3) Mean Bias% to YSI for each sample < 10%. (4) Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. Results met criteria for HCT 30% to 55%.
Interference Study	All bias of test results within the tested range ≤ 10% compared with controlled pool measurements. Concentration limits of interfering substances higher than therapeutic or physiological levels.	All bias of test results within the range were ≤ 10% compared with controlled pool. No obvious interference observed at therapeutic or physiological levels for interfering substances at two blood glucose levels.
Linearity Study	Correlation coefficient > 0.95. 100% of individual glucose results bias within ±10 mg/dL for glucose < 100 mg/dL, and ±10% for glucose ≥ 100 mg/dL, compared with YSI 2300.	Correlation coefficients were 0.9994 (Lot I), 0.99925 (Lot II), and 0.99955 (Lot III), all > 0.95. 100% of individual glucose results bias fell within ±10 mg/dL (glucose < 100 mg/dL) and ±10% (glucose ≥ 100 mg/dL) compared with YSI 2300. Linearity established from 20 to 600 mg/dL.
Operation Condition	Individual bias within ±10 mg/dL for glucose < 100 mg/dL and within ±10% for glucose ≥ 100 mg/dL. SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL.	Individual bias was within ±10 mg/dL (glucose < 100 mg/dL) and within ±10% (glucose ≥ 100 mg/dL). SD < 5.0 mg/dL (glucose < 100 mg/dL) and CV < 5.0% (glucose ≥ 100 mg/dL). Operated normally in conditions 42-111°F (6-44°C), 10-90% R.H.
Precision Study	Pooled and maximum SD < 5.0 mg/dL for glucose < 75 mg/dL. Pooled and maximum CV < 5.0% for glucose ≥ 75 mg/dL. Maximum individual bias < 10% compared with glucose analyzer YSI 2300.	Pooled and maximum SD were < 5.0 mg/dL for glucose < 75 mg/dL. Pooled and maximum CV were < 5.0% for glucose ≥ 75 mg/dL. Maximum bias for all levels was between -5.3% and 3.7%. Repeatability CVs were primarily between 1.8% and 3.5%. Intermediate Precision CVs between 3.6% and 3.9%.
Shelf-Life Study	All data meet acceptance criteria.	Unopened vials stable for 24 months. Opened vials stable for 90 days.
User Performance	(Lay users): Correlation values R' > 0.98. Populations of individual bias: ≥95% users within ±15 mg/dL for glucose < 75 mg/dL, and ≥95% users within ±15% for glucose ≥ 75 mg/dL, compared with YSI 2300.	R' values were 0.9827 (Lot I), 0.9816 (Lot II), 0.9876 (Lot III), all > 0.98. For glucose < 75 mg/dL: 100% within ±15 mg/dL for fingertip and forearm. For glucose ≥ 75 mg/dL: 100% within ±15% for fingertip and forearm.
Satisfactory Evaluation	More than 85% of volunteers agree that labels and user guide provide enough product information. More than 95% of volunteers' scores > 80 points.	More than 85% of volunteers agreed labels and user guide provided enough information. More than 95% of scores were > 80 points.
Sample Volume Study	Required at least 1.0 µL to obtain normal test results.	The sample volume of UniStrip1 Generic Blood Glucose Test Strips with OneTouch® Ultra® Meters was required at least 1.0 µL to obtain the normal testing results. Measured glucose results using sample volumes from 1.0 to 1.5 µL.
Error Message Verification	Error messages displayed correctly at given conditions.	Error messages of OneTouch® Ultra® Meters displayed correctly at given condition of procedures.

2. Sample Sizes Used for the Test Set and Data Provenance

Altitude Study: Not explicitly stated, but implies sufficient samples to demonstrate individual bias and precision metrics over the specified altitude range.
Hematocrit Study: Not explicitly stated, but samples with HCT from 30% to 55% were used.
Interference Study: Not explicitly stated, but samples with various interfering substances at different glucose levels were used.
Linearity Study: Not explicitly stated, but implies sufficient samples to establish linearity across 20 to 600 mg/dL for three strip lots.
Operation Condition Study: Not explicitly stated, but implies sufficient samples for evaluation in normal and extreme environments.
Precision Study:
- Repeatability: 100 tests per lot at each of 5 glucose levels (Total: 3 lots x 5 levels x 100 tests = 1500 tests).
- Intermediate Precision: Not explicitly stated, but likely multiple tests per lot at each of 3 glucose levels over several days for each of 3 lots.
Shelf-Life Study: Not explicitly stated.
User Performance (Lay users) Evaluation:
- Glucose < 75 mg/dL: 20 capillary blood samples for fingertip, 20 for forearm.
- Glucose ≥ 75 mg/dL: 80 capillary blood samples for fingertip, 80 for forearm.
- Linearity Analysis: Implies sufficient samples collected by lay users to generate linearity equations for 3 strip lots.
Satisfactory Evaluation: "More than 85% of volunteers" and "more than 95% of volunteers" imply a volunteer sample size, but the exact number isn't specified.
Sample Volume Study: Not explicitly stated, but involved measuring glucose with sample volumes from 1.0 to 1.5 µL.
Error Message Verification Study: Not explicitly stated.

Data Provenance: The studies were conducted by OK Biotech Co., Ltd. in Taiwan. The description does not specify if the data was retrospective or prospective, but clinical performance studies using human samples imply prospective collection for tests like user performance. Other tests (e.g., altitude, hematocrit, linearity, precision) likely used controlled laboratory samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document primarily refers to the YSI 2300 Glucose Analyzer as the reference method for establishing ground truth for glucose measurements. The YSI 2300 is a laboratory-grade analyzer, considered a gold standard for glucose measurement; therefore, specific human experts for ground truth adjudication are not typically used in this context.

4. Adjudication Method for the Test Set

Adjudication in the traditional sense (e.g., 2+1 expert consensus) is not applicable here as the ground truth for glucose concentration is established by a reference laboratory instrument (YSI 2300). The device's performance is directly compared to the results from the YSI 2300.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a blood glucose test strip system, not an AI-assisted diagnostic imaging device or similar system where human reader performance would be a primary endpoint. The "User Performance" study evaluates lay users' ability to operate the device correctly and obtain accurate readings, which is a different type of assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is a standalone device in the sense that the test strip and meter system provide a direct glucose reading. There isn't an "algorithm only" component separate from the integrated device. The performance data presented (linearity, precision, interference, etc.) represent the standalone performance of the test strip system. The "User Performance" study specifically assesses human-in-the-loop performance by lay users but is focused on correct operation and result accuracy, not on assistance with an AI algorithm.

7. The Type of Ground Truth Used

The primary ground truth used is reference measurement by a Glucose Analyzer, specifically the YSI 2300. This is considered a highly accurate laboratory method for quantitative glucose determination.

8. The Sample Size for the Training Set

The document describes performance studies and evaluation against established methods (YSI 2300).
No explicit training set or development set size is mentioned. This type of medical device (blood glucose test strips) typically undergoes analytical and clinical validation studies without a "training set" in the machine learning sense. The device's chemical and electrical components are designed and optimized, and then validated through these performance studies.

9. How the Ground Truth for the Training Set Was Established

Since no explicit training set for a machine learning model is mentioned, the concept of establishing ground truth for a training set in that context does not apply directly. The "ground truth" for evaluating the performance of the device design and manufacturing process is consistently the YSI 2300 Glucose Analyzer, as mentioned above.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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.

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(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.No. 91, Sec. 2, Gongdao 5th Road, 30070,Hsinchu City, TaiwanTelephone: +886-3-516-0258Fax:+886-3-516-0028Email: service@okbiotech.com
Date prepared	December 6, 2016
Official Correspondent	Dr. Jen, Ke-minTEL: +886-3-5208829 FAX: +886-3-520978Email: ceirs.jen@msa.hinet.net
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.UniStrip1TM Generic Blood Glucose Test StripsK160038

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: ●

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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 GlucoseTest Strips	UniStrip1 Generic Blood GlucoseTest Strips
Manufacturer	OK Biotech Co., Ltd.	OK Biotech Co., Ltd.
510(k) No.	K160038	K162430
Similarities
Test Principle	Glucose in the blood sample mixeswith glucose oxidase on theUniStrip1 test strip and a smallelectrical current is measured by themeter(s) and displayed as your bloodglucose results. The strength of thiscurrent changes with the amounts ofglucose in the blood sample.	Same
Enzyme	Glucose oxidase ( Aspergillus niger )	Same
Specimen Type	Capillary whole blood from fingertipand alternate sites (palm, forearm andupper-arm)(Use of palm AST is not to be done withOneTouch® Ultra® meter).	Same
Sample Volume	1.0 μL	Same
OperatingTemperature	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 StorageTemperature	39 - 104 °F (4 - 40 °C)	Same
Opened test stripsvial shelf life	90 days after first opening	Same
Unopened test stripsvial shelf life	24 months	Same
Brand name ofControl solution	UniStrip Control Solutions	Same
IngredientChemicals of theUniStrip1 GenericBlood Glucose TestStrips	1. Glucose oxidase (Aspergillusniger): 20 IU2. Potassium ferricyanide: 0.12 mg3. Non-reactive ingredients: 1.8 mg	Same
IngredientChemicals of theControl Solutions	1. D-Glucose2. Polyvinyl acetate (aqueousemulsion): 10%3. Antifoaming agent(Polyethylene Glycol 4000):0.02%4. Disodium EDTA: 0.1%5. Fumed silica: 0.2%6. Food Pigment Red No.6:0.05%7. Sodium Benzoate: 0.2%	Same
Differences
Indications for Use	The UniStrip1™ Generic BloodGlucose Test Strips are used with theOneTouch® Ultra®2, OneTouch®UltraMini® and OneTouch®UltraSmart® meters purchasedbefore April 2016, and OneTouch®	The UniStrip1™ Generic BloodGlucose Test Strips are used withthe OneTouch® Ultra®, OneTouchUltra®2, OneTouch® UltraMini®and OneTouch® UltraSmart®meters purchased before April
Ultra® purchased before October2012 , set at calibration code 49, formeasuring glucose (sugar) in wholecapillary blood. The strips are meantfor self-testing of blood glucose asan aid to monitor the effectiveness ofdiabetes control.They are for single patient use onlyand should not be shared.They are used to quantitativelymeasure glucose in fresh capillarywhole blood samples taken from thefinger, palm, or forearm. Testingis done outside the body (in vitrodiagnostic use).They are indicated for use by peoplewith diabetes in their home as an aidto monitor the effectiveness ofdiabetes control.Not intended for the diagnosis of orscreening for diabetes mellitus and isnot intended for use on neonates.The UniStrip1™ Generic BloodGlucose Test Strips allow alternatesite testing (AST) from the fingertip,palm and/or the forearm. (Use ofpalm AST is not to be done withOneTouch® Ultra® meter).Alternative site testing should onlybe done during steady-state times(when glucose is not changingrapidly).	2016 , set at calibration code 49,for measuring glucose (sugar) inwhole capillary blood. The stripsare meant for self-testing ofblood glucose as an aid tomonitor the effectiveness ofdiabetes control.They are for single patient useonly and should not be shared.They are used to quantitativelymeasure glucose in freshcapillary whole blood samplestaken from the finger, palm, orforearm. Testing is doneoutside the body (in vitrodiagnostic use).They are indicated for use bypeople with diabetes in theirhome as an aid to monitor theeffectiveness of diabetes control.Not intended for the diagnosis ofor screening for diabetes mellitusand is not intended for use onneonates.The UniStrip1™ Generic BloodGlucose Test Strips allowalternate site testing (AST) fromthe fingertip, palm and/or theforearm. (Use of palm AST is notto be done with OneTouch®Ultra® meter). Alternative sitetesting should only be doneduring steady-state times (whenglucose 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:service@okbiotech.com

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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.
1. 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:service@okbiotech.com

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.

1. 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.
1. 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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5. Operation condition study

The performance of the UniStrip1 Generic Blood Glucose Test Strips with OneTouch® Ultra® Meters was evaluated in the normal and extreme environments. According to the test results, the individual bias was within ±10 mg/dL at glucose concentration < 100 mg/dL and within ±10 % at glucose concentration ≥ 100 mg/dL. The SD was less than 5.0 mg/dL at glucose concentration < 100 mg/dL, and the CV was less than 5.0 % at glucose concentration ≥ 100 mg/dL. The test results met the acceptance criteria. Therefore, UniStrip1 Generic Blood Glucose Test Strips used with the OneTouch® Ultra® Blood Glucose Meters and UniStrip Control Solutions were operated normally in the conditions 42- 111 F (6~44 °C), 10 – 90% R.H.

1. Precision study per NCCLS/CLSI EP05-A3:2015 Evaluation of Precision of Quantitative Measurement Procedures, Approved Guideline-Third Edition (In Vitro Diagnostics) (FDA Recognition Number 7-251)
  According to the test results, the pooled and maximum SD were less than 5.0 mg/dL at glucose concentration < 75 mg/dL, and pooled and maximum CV were less than 5.0 % at glucose concentration ≥ 75 mg/dL. The maximum individual bias were less than 10 % compared with glucose analyzer YSI 2300. The test results shown in the following tables met the acceptance criteria

Level	Level I	Level II	Level III	Level IV	Level V
YSI 2300	43.3	79.6	129	201	325
Mean	43.0	79.1	129	201.4	324.6
Max Bias	-5.3%	-3.3%	3.1%	3.5%	3.7%
Max CV	3.7%	2.0%	2.4%	2.3%	2.6%
Pooled CV	3.3%	1.8%	2.0%	2.1%	2.2%

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Image /page/11/Picture/0 description: The image contains a logo with the letters 'K' and 'b' intertwined, followed by the word 'biotech' in bold font. Below the word 'biotech' is a line of text in a different language, possibly Chinese or Japanese. The logo appears to represent a company or organization named 'Kbiotech'.

TEL : 886-3-5160258 FAX : 886-3-5160028 Taiwan : China : TEL : 86-791-3899362 FAX : 86-791-3880131

http://www.okbiotech.com E-mail:service@okbiotech.com

Repeatability	Lot I					Lot II					Lot III
Mean (mg/dL)	42.9	79.1	129.2	201.5	325.6	43.0	79.0	128.8	201.3	324.2	42.9	79.1	129.0	201.3	324.2
SD	1.4	1.5	2.8	4.1	6.8	1.4	1.5	2.7	4.2	7.8	1.5	1.4	2.5	4.7	6.8
CV	3.2%	1.8%	2.1%	2.0%	2.1%	3.2%	1.9%	2.1%	2.1%	2.4%	3.5%	1.8%	1.9%	2.3%	2.1%
n	100	100	100	100	100	100	100	100	100	100	100	100	100	100	100

Intermediate Precision	Lot I			Lot II			Lot III
Mean (mg/dL)	39.1	119.2	258.1	39.0	118.5	256.6	39.0	119.2	257.6
SD	1.4	4.6	9.6	1.4	4.6	9.5	1.4	4.6	10.0
CV	3.6%	3.8%	3.7%	3.6%	3.9%	3.7%	3.6%	3.9%	3.9%

1. Shelf-Life study per EN 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents According to the test results, all of the data met the acceptance criteria. That is, the unopened vials of the UniStrip1 Generic Blood Glucose Test Strips were stable for 24 months and 90 days for opened vials.

8. User performance (Lay users) evaluation

After a certain period of independent reading, the blood glucose monitoring systems can be operated properly by a lay user for fingertips and alternate site testing (the forearm). All of correlation values R' were greater than 0.98, and it meant glucose measurements of the UniStrip1 Generic Blood Glucose Test Strips with the OneTouch® Ultra® Meters were highly correlated to the measurements of Glucose Analyzer YSI 2300. The test results show that the populations of individual bias ± 15 mg/dL at blood glucose concentration < 75 mg/dL and ± 15 % at blood glucose concentration ≥ 75 mg/dL compared with Glucose Analyzer YSI 2300 are more than 95 %. The test results met the acceptance criteria. That is, the blood glucose monitoring system could be operated properly by lay users.

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Image /page/12/Picture/0 description: The image shows the logo for Kbiotech. The logo consists of 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 smaller font, which appears to be in Chinese.

E-mail:service@okbio

Measurements performed by lay users for Lot I versus YSI 2300

For glucose concentration < 75 mg/dL
Test site	Within ±5 mg/dL	Within ±10 mg/dL	Within ±15 mg/dL
Fingertip	13/20 (65.0%)	17/20 (85.0%)	20/20 (100.0%)
Forearm	13/20 (65.0%)	18/20 (90.0%)	20/20 (100.0%)

For alucose concentration < 75 mg/dl

For glucose concentration ≥ 75 mg/dL

Test site	Within ±5%	Within ±10%	Within ±15%	Within ±20%
Fingertip	52/80 (65.0%)	71/80 (88.8%)	80/80 (100.0%)	80/80 (100.0%)
Forearm	50/80 (62.5%)	73/80 (91.3%)	80/80 (100.0%)	80/80 (100.0%)

Linearity analysis results for fingertip test

Strip lots	Linearity equation	R2
Lot I	Y=0.9982X+1.2235	0.9827
Lot II	Y=0.9658X+3.4959	0.9816
Lot III	Y=1.0132X-2.2274	0.9876

9. Satisfactory evaluation

More than 85 % of volunteers agreed that the labels on the packing and the users' guide provided enough information of the product for the readers. More than 95 % of volunteers' scores were higher than 80 points. It indicates that the written materials could provide enough information of the product for the lay users, so they can comprehend the contents easily even without the explanation by professional.

10. Sample volume study

As the test results show the glucose measurements of sample volume are from 1.0 to 1.5 µL. The sample volume of UniStrip1 Generic Blood Glucose Test Strips with OneTouch® Ultra® Meters was required at least 1.0 µL to obtain the normal testing results.

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Image /page/13/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter "K" with a circular design element surrounding it. The word "biotech" is written in a smaller, sans-serif font to the right of the "K". Below the logo, there is some text in a different language, possibly Chinese or Japanese.

http://www.okbiotech.com

E-mail: service@okbiotech.com

11. Error message verification study

According to our test results, the error messages of OneTouch® Ultra® Meters displayed correctly at the given condition of procedures. The test results of UniStrip1 Generic Blood Glucose Test Strips met the acceptance criteria.

1. MSDS for Glucose Oxidase in UniStrip1 Generic Blood Glucose Test Strips

MSDS for PET in UniStrip1 Generic Blood Glucose Test Strips

● Synopsis of Test Methods and Results

Pre-clinical data are employed upon submission of this 510(k) premarket notification according to the FDA Guidance Document: Review Criteria of Portable Blood Glucose Monitoring in Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. 02/28/1997.

● Conclusions

Based on the comparison table, substantial equivalence discussion, and FDA guidance document, OK Biotech concludes that no new issues of safety and effectiveness have been raised in this original 510(k) submission for the UniStrip1 Generic Blood Glucose Test Strips used with the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and One-Touch® UltraSmart® meters purchased before April 2016.

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.