The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra@2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016, and OneTouch® Ultra® purchased before October 2012, 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).

The UniStrip™ Control Solutions are for use with the UniStrip1™ Generic Blood Glucose Test Strips and OneTouch® Ultra® meters to check that the meters and test strip are working together properly and that the test is performing correctly.

Device Description

UniStrip1 Generic Blood Glucose Test Strips are used with the OneTouch® Ultra, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters. The 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. 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). UniStrip1 Generic Blood Glucose Test Strips can only be used with the OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016, and OneTouch® Ultra® purchased before October 2012. UniStrip1 Generic Blood Glucose Test Strips are only for use with calibration code 49.

AI/ML Overview

The document provided describes the UniStrip1 Generic Blood Glucose Test Strips and the studies conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several tests conducted according to ISO 15197:2013 and other CLSI/NCCLS standards. The acceptance criteria are generally qualitative (e.g., "met acceptance criteria," "within ±10 mg/dL," "less than 5.0 %"). For the User Performance Evaluation, a specific quantitative acceptance criterion is provided.

Test / Performance Metric	Acceptance Criteria (as stated in document)	Reported Device Performance (as stated in document)
Sample Volume	Glucose measurements meet acceptance criteria. Required sample volume at least 1.0 µL to obtain normal testing results.	Glucose measurements of sample volume from 1.0 to 1.5 µL met acceptance criteria for normal testing results.
Operation Condition	Individual bias within ±10 mg/dL at glucose < 75 mg/dL and within ±10% at glucose ≥ 75 mg/dL. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL.	Individual bias within ±10 mg/dL at glucose < 75 mg/dL. Individual bias within +10% at glucose ≥ 75 mg/dL. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Operated normally in conditions 42-111 °F (6-44°C), 10-90% R.H.
Hematocrit Study	1. All SD and CV < 5 mg/dL and 5%, respectively. 2. All individual bias vs. YSI mean < 15%. 3. Mean Bias% to YSI for each sample at each Hct level < 10%. 4. Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. Test results met acceptance criteria. Hematocrit range from 30% to 55% available.	Met all four acceptance criteria. HCT ranges from 30% to 55% are available.
Altitude Study	Individual bias within ±10%. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Test results met acceptance criteria. No significant effects from various altitudes.	Individual bias within ±10% at altitude from 298ft (91m) to 11,161ft (3,402m). SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Claims use up to 10,000 ft.
Linearity Study	R² > 0.95. 100% of individual glucose results within ±10 mg/dL at glucose < 75 mg/dL, and within ±10% at glucose > 75 mg/dL compared with Glucose Analyzer YSI 2300. Test results met acceptance criteria. Linearity available from 20 to 600 mg/dL.	Reported R² values for all meters and test sites are > 0.98 (ranging from 0.9829 to 0.9884), exceeding the >0.95 criterion. 100% of bias fell within ±10 mg/dL (<75 mg/dL) and ±10% (>75mg/dL) compared to YSI 2300. Linearity available from 20 to 600 mg/dL.
Precision Study	Pooled and maximum SD < 5.0 mg/dL at glucose < 75 mg/dL. Pooled and maximum CV < 5.0% at glucose ≥ 75 mg/dL. Maximum individual bias < 10% compared with glucose analyzer YSI 2300. Test results met acceptance criteria.	Within Run: SDs ranged from 1.2 to 8.2 mg/dL; CVs ranged from 1.5% to 3.5%. Between Run: SDs ranged from 0.8 to 8.0; CVs ranged from 2.1% to 3.1%. All stated to meet acceptance criteria for repeatability and intermediate precision. Maximum individual bias within 10% compared to YSI 2300.
Interference Study	All bias of test results for interfering substances within the range listed were < 10% compared with controlled pool measurements. No obvious interference observed at therapeutic or physiological levels.	All bias of test results within the listed range were < 10% compared with measurements of the controlled pool. No obvious interference observed in interfering substances at therapeutic nor physiological levels.
Shelf-Life Study	All data met acceptance criteria. Expected closed vial stability of 24 months, in-use vials 90 days for strips. Expected closed and in-use vial stability of 18 months and 90 days respectively for control solutions.	All data met the acceptance criteria. Closed vials of UniStrip1 Generic Blood Glucose Test Strips stable for 24 months, and 90 days for in-use vials. Closed and in-use vials of UniStrip Control Solutions stable for 18 months and 90 days respectively.
User Performance	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 %. Test results met acceptance criteria, demonstrating proper operation by lay users.	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 %.
Satisfactory Evaluation	More than 85% of volunteers agree labels/user guide provide enough info. More than 95% of volunteers' scores > 80 points.	More than 85% of volunteers agree that the labels on the packing and the users' guide provided enough information. More than 95% of volunteers' scores were higher than 80 points.

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

Sample Volume Study: Not explicitly stated, but "sample volume from 1.0 to 1.5 µL" was tested.
Operation Condition Study: Not explicitly stated.
Hematocrit Study: Not explicitly stated.
Altitude Study: Not explicitly stated.
Linearity Study: Not explicitly stated for each test point, but the method NCCLS/CLSI EP6-A:2014 suggests multiple readings across the range.
Precision Study (Repeatability): For each of the 3 meters (OneTouch Ultra2, UltraMini, UltraSmart), 3 lots were tested, with 5 different glucose concentrations. For each concentration/lot/meter combination, n=50 measurements were taken. (e.g., 3 meters * 3 lots * 5 concentrations * 50 measurements = 2250 total measurements for repeatability study).
Precision Study (Intermediate Precision): 3 lots were tested with 3 different glucose concentrations. Sample size not explicitly stated for each condition, but likely drawn from the broader precision study data.
Interference Study: Not explicitly stated.
Shelf-Life Study: Not explicitly stated.
User Performance Evaluation: Not explicitly stated for the number of lay users.
Satisfactory Evaluation: Not explicitly stated for the number of volunteers.

Data Provenance: The studies were conducted by OK BIOTECH CO., LTD. (Taiwan). The document does not specify the country of origin of the human blood samples used in the studies (e.g., for hematocrit, user performance). The studies are "pre-clinical data," implying they were conducted prospectively for the purpose of this 510(k) submission.

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

No information is provided regarding the number of experts used or their qualifications for establishing ground truth for any of the studies.
The ground truth reference method explicitly mentioned is the Glucose Analyzer YSI 2300. This is a laboratory reference instrument, not a human expert.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied as the ground truth is established by a laboratory instrument (YSI 2300) rather than human interpretation that would typically require adjudication.

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, which provides a quantitative measurement, and does not involve human "readers" in the diagnostic interpretation sense that an AI-assisted imaging device would. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device (test strip + meter) is inherently a standalone system in terms of generating a glucose reading. The User Performance Evaluation evaluates the ability of lay users to operate the system correctly and obtain accurate results, which is a human-in-the-loop operational assessment, but the performance of the device itself in producing the glucose value is "standalone" from a diagnostic interpretation perspective. The closest comparison would be the linearity and precision studies that demonstrate the device's accuracy against a lab reference, which is essentially a standalone performance evaluation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for quantitative glucose measurements in several studies (Linearity, Precision, Hematocrit, User Performance) was established using a Glucose Analyzer YSI 2300. This is a laboratory reference instrument for measuring glucose concentration.

8. The Sample Size for the Training Set

No information is provided about a specific "training set" or its size. This type of medical device (blood glucose test strip) does not typically involve machine learning or AI models that require distinct training sets in the same manner as image analysis algorithms. The device's performance is characterized through direct analytical and clinical studies.

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

As no training set is mentioned or implied for this type of device, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap and create a sense of movement.

July 29, 2016

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

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

Re: K160038

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, JJX Dated: June 3, 2016 Received: June 14, 2016

Dear Dr. KeMin 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 (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,

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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Indications for Use

510(k) Number (if known) K160038

Device Name

UniStrip1 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).

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)

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 Druq 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."

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Image /page/3/Picture/0 description: The image shows a logo with the letter K inside of two circles. To the right of the K is the word "biotech" in a bold, sans-serif font. Below the logo is text in a different language, possibly the company's name in another language. The logo appears to be for a company called "Kbiotech."

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

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

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 ProposedDevice	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, Taiwan
	Telephone: +886-3-516-0258
	Fax:+886-3-516-0028
	Email: service@okbiotech.com
Owner Number	9090860
Date prepared	July 29, 2016
Official Correspondent	Dr. JEN, KE-MIN
	TEL: 886-3-5208829FAX: 886-3-5209783
	Email: ceirs.jen@msa.hinet.net
Preference For ContinuedConfidentiality (21 CFR 807.95)	510(k) Summary
Device Classification Name	System, Test, Blood Glucose, Over The Counter
Regulation Description	Glucose test system
Review Panel	Clinical Chemistry
Product Code	NBW, CGA, JJX
Regulation number	21 CFR 862.1345
Class	2
Primary Predicate Device	UniStrip Technologies, LLC
	UniStrip1TM Test Strips
	K113135
Secondary Predicate Device(for control solution)	DIAGNOSTIC DEVICES, INC
	PRODIGY BLOOD GLUCOSE TEST SYSTEM
	K060467

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Image /page/4/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 word "biotech" is some text in a different language.

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

. 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, and OneTouch® Ultra® purchased before October 2012, 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 UniStrip™ Control Solutions are for use with the UniStrip1TM Generic Blood Glucose Test Strips and OneTouch® Ultra® meters to check that the meters and test strip are working together properly and that the test is performing correctly.

● Device Description:

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Image /page/5/Picture/0 description: The image shows a logo with the letter K inside of a circle. To the right of the logo is the word "biotech" in a stylized font. Below the logo and the word is a line of text in a different language. The logo appears to be for a company or organization related to biotechnology.

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

● 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
Manufacturer	UniStrip Technologies, LLC	OK Biotech Co., Ltd.
Device tradename	UniStrip1™ Test Strips	UniStrip1 Generic Blood GlucoseTest Strips
510(k) number	K113135	K160038
Common name	Blood Glucose Test Strips	Blood Glucose Test Strips
Classificationname	System, Test, Blood Glucose, OverThe Counter	System, Test, Blood Glucose, OverThe Counter
RegulationDescription	Glucose, Oxidase, Glucose	Glucose, Oxidase, Glucose
Product code	NBW, CGA	NBW, CGA, JJX
Regulationnumber	21 CFR 862.1345	21 CFR 862.1345
Device class	II	II
Review panel	Clinical Chemistry	Clinical Chemistry
Similarities
Test Principle	The OneTouch® Ultra® Family Metersare plasma-calibrated to allow easycomparison of results with laboratorymethods. Glucose in the blood samplemixes with special chemicals on theUniStrip1 Test Strips and a small	Same test principle

	electrical current is produced. Thiscurrent is measured by the OneTouch®Ultra® Family Meters and displayed asyour blood glucose result. The strengthof the current changes with the amountof glucose in the blood sample.
Enzyme	Glucose oxidase (Aspergillus niger)	Same enzyme
Specimen Type	Capillary whole blood from fingertipand alternative sites palm, forearm.(Use of palm AST is not to be donewith OneTouch® Ultra® meter).	Same specimen type
Sample Volume	1.0 µL	Same sample volume
OperatingTemperature	42 - 111 °F (6 - 44 °C)10 - 90% R.H.	Same operating temperature
HCT Range	30 - 55%	Same HCT range
Calibration	Code 49 only	Same calibration code
Detecting Limit	20 - 600 mg/dL	Same detecting limit
Measuring time	5 seconds	Same measuring time
Open vial shelflife	90 days after opening	Same open vial shelf life
Chemicalmakeup of teststrips	1. Glucose oxidase (Aspergillus niger):20 IU2. Potassium ferricyanide: 0.12 mg3. Non-reactive ingredients: 1.8 mg	Same chemical makeup of test strips
	510(k) cleared as K060467
Chemicalmakeup ofcontrol solution	1. D-Glucose2. Polyvinyl acetate (aqueousemulsion): 10%3. Antifoaming agent (PolyethyleneGlycol 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 chemical makeup of controlsolution as K060467
Differences:
Item	Predicate device	Subject device
Indications foruse	The UniStrip1 Test Strips are usedwith the OneTouch® Ultra®,OneTouch® Ultra®2, OneTouch®UltraMini® and One-Touch®UltraSmart® meterspurchased before October 2012, set atcalibration code 49, for measuringglucose (sugar) in whole capillaryblood. The Unistrip1 TM is meant forself-testing of blood glucose as an aidto 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.Testing is done outside the body (invitro diagnostic 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.UniStrip1 Test Strips allow alternatesite testing (AST) from the fingertip,palm and/or the forearm. (Use of palmAST is not to be done withOneTouch® Ultra® meter). Alternativesite testing (AST) should only be doneduring steady-state times (whenglucose is not changing rapidly).	The UniStrip1™ Generic BloodGlucose Test Strips are used with theOneTouch® Ultra®2, OneTouch®UltraMini® and OneTouch®UltraSmart® meters purchased beforeApril 2016, and OneTouch® Ultra®purchased before October 2012, set atcalibration code 49, for measuringglucose (sugar) in whole capillaryblood. The strips are meant forself-testing of blood glucose as an aidto monitor the effectiveness of diabetescontrol.They are for single patient use only andshould not be shared.They are used to quantitatively measureglucose in fresh capillary whole bloodsamples taken from the finger, palm, orforearm.Testing is done outside the body (invitro diagnostic use).They are indicated for use by peoplewith diabetes in their home as an aid tomonitor the effectiveness of diabetescontrol.Not intended for the diagnosis of orscreening for diabetes mellitus and isnot intended for use on neonates.The UniStrip1™ Generic BloodGlucose Test Strips allow alternate sitetesting (AST) from the fingertip, palmand/or the forearm. (Use of palm ASTis not to be done with OneTouch®Ultra® meter). Alternative site testingshould only be done during steady-statetimes (when glucose is not changingrapidly).The UniStrip™ Control Solutionsare for use with the UniStrip1™Generic Blood Glucose Test Stripsand OneTouch® Ultra® meters tocheck that the meters and test stripare working together properly andthat the test is performing correctly.
Strip StorageTemperature	39 °F – 86 °F(4°C – 30 °C)	39 °F – 104 °F(4 °C – 40 °C)
Brand name ofControl solution	Prodigy Control Solution (K060467)	UniStrip Control Solution(same as K060467)

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Image /page/6/Picture/0 description: The image shows the logo for "Kbiotech". The logo features a stylized letter "K" enclosed in a circular design, followed by the word "biotech" in a bold, italicized font. Below the word "biotech" are Chinese characters, likely representing the company's name or a related description.

http://www.okbiotech.com

E-mail:service@okbiotech.com

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Image /page/7/Picture/0 description: The image shows a logo with the letters 'K' and 'biotech' stacked on top of each other. The 'K' is stylized with a circular design around it. Below the word 'biotech' is a line of text in a different language, possibly Chinese. The logo appears to be for a company named 'Kbiotech'.

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

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

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Image /page/8/Picture/0 description: The image contains a logo with the letter K inside of a circular design. Next to the logo is the word "biotech" in bold, italicized letters. Below the word biotech is a line of text in a different language.

Taiwan : TEL : 886-3-5160258 FAX : 886-3-5160028 TEL : 86-791-3899362 FAX : 86-791-388013 China :

http://www.okbiote E-mail: service a okbio

● Safety and Effectiveness Tests and Non-Clinical Studies

The following tests and studies were conducted to ensure the UniStrip1 Generic Blood Glucose Test Strips used with the following blood glucose meters: OneTouch Ultra 2, OneTouch® UltraMini® and One-Touch® UltraSmart® meters purchased before April 2016, and OneTouch® Ultra® purchased before October 2012 were safe and effective in measuring blood glucose concentration.

1. Sample volume study per ISO 15197:2013 In vitro diagnostic test systems -Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus
  As the test results shown, the glucose measurements of sample volume from 1.0 to 1.5 µL met acceptance criteria. The sample volume of the System was required at least 1.0 µL to obtain the normal testing results.
1. Operation condition study per EN 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
  The performance of the UniStrip1 Generic Blood Glucose Test Strips with OneTouch Series Blood Glucose 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 < 75 mg/dL and within +10 % at glucose concentration ≥ 75 mg/dL. The SD was less than 5.0 mg/dL at glucose concentration < 75 mg/dL, and the CV was less than 5.0 % at glucose concentration ≥ 75 mg/dL. The test results met the acceptance criteria. Therefore, UniStrip1 Generic Blood Glucose Test Strips and UniStrip Control Solution were operated normally in the conditions 42 -111 °F (6 - 44°C), 10 - 90% R.H.

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Image /page/9/Picture/0 description: The image shows a logo with the letter K inside of a circular design. Next to the K is the word "biotech" in bold, black font. Below the word biotech is a line of text in a different language.

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

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 study 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 15%, (3) the Mean Bias% to YSI for each sample of blood glucose concentration at each hematocrit level was less than 10%, and (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 used with OneTouch Ultra series including Ultra2, UltraMini and UltraSmart purchased before April 2016.
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 SD at blood glucose concentration < 75 mg/dL and CV at the blood glucose concentration ≥ 75 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 Series Blood Glucose Meters including OneTouch Ultra2, UltraMini and UltraSmart at various altitudes from 298 feet to 11,161 feet (91 to 3,402 meters). Thus we claim the UniStrip1 Generic Blood Glucose Test Strips with OneTouch Ultra series including OneTouch Ultra2, OneTouch UltraMini and OneTouch UltraSmart purchased before April 2016 can be used up to 10,000 ft

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 the test results shown in the following table, the correlation coefficient R2 is greater than 0.95. That is to say, our test results were highly

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Image /page/10/Picture/0 description: The image shows a logo for Kbiotech. The logo features a stylized letter "K" with a ring around it, followed by the word "biotech" in bold, sans-serif font. Below the word "biotech" is text in a different language, possibly Chinese, which appears to be the company's name or a description.

E-mail:service@okbiotech.com

correlated with YSI 2300. The linearity is available from 20 to 600 mg/dL. 100 % of the bias of individual glucose results fallen within ± 10 mg/dL at glucose concentration < 75 mg/dL, and within ±10% at glucose concentration > 75 mg/dL compared with Glucose Analyzer YSI 2300. The test results met the acceptance criteria. So the UniStrip1 Generic Blood Glucose Test Strips used with the One Touch Ultra2, One Touch UltraMini and OneTouch UltraSmart purchased before April 2016 pass the linearity study.

Meter	Test Site	Linearity	R2
One Touch®Ultra 2®	Fingertip	Y=0.9783X + 1.4938	0.9829
	Palm	Y=0.9718X + 2.3621	0.9876
	Forearm	Y=0.9945X - 0.891	0.9865
One Touch®UltraMini®	Fingertip	Y=0.9759X + 1.686	0.9849
	Palm	Y=0.9928X - 0.7268	0.9848
	Forearm	Y=0.9773X + 1.299	0.9856
One Touch®UltraSmart®	Fingertip	Y=0.9806X + 1.3315	0.9853
	Palm	Y=0.9924X - 0.8447	0.9849
	Forearm	Y=1.0152X - 2.6014	0.9884

Linear regression analysis:

1. Precision study per NCCLS/CLSI EP05-A3:2015 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline- Third Edition (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 was less than 10 % compared with glucose analyzer YSI 2300. The test results met the acceptance criteria. The UniStrip1 Generic Blood Glucose Test Strips used with the OneTouch Ultra series meters, including OneTouch Ultra2, OneTouch UltraMini and OneTouch UltraSmart. purchased before April 2016, pass the repeatability evaluation and intermediate precision evaluation.

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

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Within Run	Lot I					Lot II					Lot III
Repeatability
OneTouch®Ultra®2	Mean (mg/dL)	42.0	79.2	128.9	199.0	324.8	41.8	78.9	129.0	199.1	324.5	41.7	79.0	128.3	198.8	322.6
	SD	1.4	1.4	2.6	3.6	7.2	1.5	1.4	2.6	3.9	6.1	1.5	1.5	2.7	4.3	7.2
	CV	3.3%	1.8%	2.0%	1.8%	2.2%	3.5%	1.8%	2.0%	2.0%	1.9%	3.5%	1.9%	2.1%	2.2%	2.2%
	n	50	50	50	50	50	50	50	50	50	50	50	50	50	50	50
OneTouch®UltraMini®	Mean (mg/dL)	41.7	79.1	128.4	198.7	326.3	42.3	79.2	129.4	198.4	325.6	41.9	78.9	129.3	199.1	322.2
	SD	1.4	1.5	2.5	4.6	8.2	1.4	1.5	2.7	4.3	9.3	1.4	1.3	2.8	4.4	8.8
	CV	3.2%	1.9%	1.9%	2.3%	2.5%	3.3%	1.9%	2.1%	2.2%	2.9%	3.4%	1.7%	2.2%	2.2%	2.7%
	n	50	50	50	50	50	50	50	50	50	50	50	50	50	50	50
OneTouch®UltraSmart®	Mean (mg/dL)	42.5	79.0	129.2	199.0	324.1	42.0	78.8	129.1	198.3	325.5	41.6	79.5	130.0	199.0	325.6
	SD	1.3	1.2	2.8	4.5	6.5	1.4	1.1	2.7	4.4	7.9	1.4	1.4	2.6	4.0	7.6
	CV (%)	3.1%	1.5%	2.2%	2.3%	2.0%	3.2%	1.5%	2.1%	2.2%	2.4%	3.4%	1.8%	2.0%	2.0%	2.3%
	n	50	50	50	50	50	50	50	50	50	50	50	50	50	50	50

Between Run

Intermediate Precision	Lot I			Lot II			Lot III
Mean (mg/dL)	39.0	118.9	260.5	39.0	119.2	259.7	39.0	119.0	260.3
SD	0.8	3.2	8.0	0.8	3.1	7.7	0.8	3.3	8.0
CV	2.1%	2.7%	3.1%	2.1%	2.6%	3.0%	2.1%	2.8%	3.1%

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 NCCLS/CLSI EP07-A2:2007 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (FDA recognition number 7-127)
  According to the data, all bias of test results within the range listed above were less than 10% compared with the measurements of the controlled pool. Based on the testing results, the concentration limits of all the interfering substances were higher than therapeutic or physiological levels. That is to say, no obvious interference was observed in the interfering substance at neither therapeutic nor physiological levels at two blood glucose levels.
1. Error message verification study
1. Shelf-Life study per EN 23640:2013 In vitro diagnostic medical devices.

Evaluation of stability of in vitro diagnostic reagents and ISO 15197:2013 in vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus

According to the test results, all of the data met the acceptance criteria. The closed vials of the UniStrip1 Generic Blood Glucose Test Strips are stable for 24 months and 90 days for in-use vials. The closed and in-use vials of UniStrip Control Solutions were stable for 18 months and 90 davs respectively.

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10. User Performance Evaluation per ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus and ISO 15725-1:2011 Accuracy (trueness and precision) of measurement methods and results - Part 1: Introduction and basic principles

According to the evaluation results, after a certain period of manual reading, the blood glucose monitoring systems can be operated properly by a lav user for finger and alternative site testing (the palm and forearm). 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 lav users. That is, UniSrtip1 Generic Blood Glucose Test Strips with OneTouch Ultra series meters purchased before April 2016, including OneTouch Ultra2, OneTouch UltraMini and One-Touch UltraSmart meters could be operated properly by lay users.

11. Satisfactory Evaluation

More than 85 % of volunteers agree that the labels on the packing and the users' guide provided enough information of the product for the readers. More than 95 % of volunteers' score 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 instructions given by professional.

1. MSDS for D-Glucose in UniStrip Control Solutions
1. MSDS for Glucose Oxidase in UniStrip1 Generic Blood Glucose Test Strips
1. MSDS for PET in UniStrip1 Generic Blood Glucose Test Strips

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● Substantial Equivalence (SE) Discussion

A claim of substantial equivalence is made to UniStripl Test Strips (K113135) made by UniStrip Technologies, LLC. Both of them have the similar indications for use, the same working principle and technologies including using the same chemical makeup of test strips and control solution, the same sample volume, same measuring time, same operating temperature, same HCT range, same open vial shelf life, same calibration code, and detecting range.

The major differences for two devices are the extended valid period between October 2012 and April 2016 of the subject device used with OneTouch® Ultra®2, OneTouch® UltraMini® and One-Touch® UltraSmart® meters, strip storage temperature and brand name of control solution. The subject device covers 2.5 more vears of valid period than the predicate device. The more 18 Fahrenheit degrees in strip storage temperature range than the predicate device has been validated and verified by the relevant testing to show the expected performance of blood glucose measuring for the subject device. The UniStrip Control Solutions are made up of the same chemical makeup as the predicate Prodigy Control Solution. Refer to the attached "Transfer and Assignment of 510(K) Ownership and Registrations 2012-24-12". These differences will not pose any change in the safety and effectiveness. Besides, the subject device and predicate device are same intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, and the following alternative sites: the palm and the forearm. The differences will not raise any safety and effectiveness concerns. They are substantially equivalent.

● 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.

● Conclusion

Based on the comparison table, the comparison discussion, complying standards and FDA guidance, we 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®2, OneTouch® UltraMini® and One-Touch® UltraSmart® meters purchased before April 2016, and OneTouch® Ultra® purchased before October 2012.

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.