UniStrip1 Generic Blood Glucose Test Strips

K160038 · Ok Biotech Co., Ltd. · NBW · Jul 29, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160038
• Device Name: UniStrip1 Generic Blood Glucose Test Strips
• Applicant: Ok Biotech Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 29, 2016
• 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 Ultra2, OneTouch UltraMini and One-Touch UltraSmart meters purchased before April 2016, and the 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. 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 One Touch Ultra meters to check that the meters and test strips are working together properly and that the test is performing correctly.

Device Story

UniStrip1 Generic Blood Glucose Test Strips are single-use, in vitro diagnostic strips for quantitative glucose measurement in capillary whole blood. Used with specific LifeScan OneTouch meters (Ultra, Ultra2, UltraMini, UltraSmart) at calibration code 49. Principle: amperometric assay using glucose oxidase enzyme; blood sample (1.0 µL) reacts with enzyme to generate electrical current proportional to glucose concentration. Operated by patients at home via fingerstick or alternate site testing (palm/forearm). Output displayed on meter screen to assist in diabetes management. Includes UniStrip Control Solutions to verify system performance. Device modifications include extended meter compatibility dates, updated storage temperature range, and name changes.

Clinical Evidence

Clinical study with 140 lay users comparing fingerstick, palm, and forearm testing against YSI-2300 reference. Results showed high accuracy across glucose ranges (47-467 mg/dL). Precision/reproducibility studies (within-run and between-run) demonstrated CVs generally <3.5%. Analytical performance included interference testing, hematocrit range (30-55%), and altitude testing (up to 10,000 ft), all meeting acceptance criteria.

Technological Characteristics

Test strips utilize glucose oxidase (Aspergillus niger) and potassium ferricyanide. Dimensions/form factor: disposable test strip. Energy source: electrical current generated by electrochemical reaction, measured by external meter. Connectivity: none (standalone strip). Sterilization: not specified. Software: none (embedded in external meter).

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 of diabetes or neonatal use. Contraindicated for critically ill patients, patients in shock, severe dehydration, hyperosmolar states, 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™ Test Strips (K113135)
• PRODIGY BLOOD GLUCOSE TEST SYSTEM (K060467)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K160038

### Device Name

UniStrip1 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, 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.

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."

{3}------------------------------------------------

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 : [phone] FAX : [phone] China: TEL:[phone] FAX:[phone]

> http://www.okbiotech.com E-mail:[e-mail]

# 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<br>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, Taiwan |
| | Telephone: [phone] |
| | Fax:[phone] |
| | Email: [e-mail] |
| Owner Number | 9090860 |
| Date prepared | July 29, 2016 |
| Official Correspondent | Dr. JEN, KE-MIN |
| | TEL: [phone]<br>FAX: [phone] |
| | Email: [e-mail] |
| Preference For Continued<br>Confidentiality (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<br>(for control solution) | DIAGNOSTIC DEVICES, INC |
| | PRODIGY BLOOD GLUCOSE TEST SYSTEM |
| | K060467 |

{4}------------------------------------------------

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 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 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:

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.

{5}------------------------------------------------

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:[e-mail]

#### ● 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 trade<br>name | UniStrip1™ Test Strips | UniStrip1 Generic Blood Glucose<br>Test Strips |
| 510(k) number | K113135 | K160038 |
| Common name | Blood Glucose Test Strips | Blood Glucose Test Strips |
| Classification<br>name | System, Test, Blood Glucose, Over<br>The Counter | System, Test, Blood Glucose, Over<br>The Counter |
| Regulation<br>Description | Glucose, Oxidase, Glucose | Glucose, Oxidase, Glucose |
| Product code | NBW, CGA | NBW, CGA, JJX |
| Regulation<br>number | 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 Meters<br>are plasma-calibrated to allow easy<br>comparison of results with laboratory<br>methods. Glucose in the blood sample<br>mixes with special chemicals on the<br>UniStrip1 Test Strips and a small | Same test principle |
| | | |
| | electrical current is produced. This<br>current is measured by the OneTouch®<br>Ultra® Family Meters and displayed as<br>your blood glucose result. The strength<br>of the current changes with the amount<br>of glucose in the blood sample. | |
| Enzyme | Glucose oxidase (Aspergillus niger) | Same enzyme |
| Specimen Type | Capillary whole blood from fingertip<br>and alternative sites palm, forearm.<br>(Use of palm AST is not to be done<br>with OneTouch® Ultra® meter). | Same specimen type |
| Sample Volume | 1.0 µL | Same sample volume |
| Operating<br>Temperature | 42 - 111 °F (6 - 44 °C)<br>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…