(141 days)
Not Found
No
The summary describes a standard blood glucose test strip and its performance characteristics when used with specific meters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) product used for measuring glucose levels to monitor diabetes, not for treating it.
Yes
The device is described as "aid to monitor the effectiveness of diabetes control," which qualifies as a diagnostic purpose. It quantitatively measures glucose in blood samples, which is a key parameter for managing a medical condition. However, it explicitly states it is "Not intended for the diagnosis of or screening for diabetes mellitus," clarifying its role is for monitoring and management rather than initial diagnosis.
No
The device is a blood glucose test strip, which is a physical component used in conjunction with a blood glucose meter. It is an in vitro diagnostic device that measures glucose in a blood sample.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (in vitro diagnostic use)."
- Device Description: The "Device Description" section also states: "The UniStrip1 Generic Blood Glucose Test Strips are intended for use outside the body (in vitro diagnostic use)..."
- Function: The device measures glucose in whole capillary blood samples taken from the body, but the measurement itself is performed in vitro (outside the body) using the test strip and meter.
These points clearly indicate that the UniStrip1™ Generic Blood Glucose Test Strips are designed and intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®2, OneTouch®, UltraMini® and OneTouch®, UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control. They are for single patient use only and should not be shared. They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use). They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®, Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, palm, or forearm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
self-testing / home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Altitude study per ISO 15197:2013: 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
§ 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.
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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.
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 (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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162430
Device Name
UniStrip1TM Generic Blood Glucose Test Strips
Indications for Use (Describe)
The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®2, OneTouch®, UltraMini® and OneTouch®, UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.
They are for single patient use only and should not be shared.
They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).
They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®, Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
1 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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, Taiwan | |
| Telephone: +886-3-516-0258 | |
| Fax:+886-3-516-0028 | |
| Email: service@okbiotech.com | |
| Date prepared | December 6, 2016 |
| Official Correspondent | Dr. Jen, Ke-min |
| TEL: +886-3-5208829 FAX: +886-3-520978 | |
| Email: 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 Strips | |
| K160038 |
리 트레 t Cofet -----E FAQULI C
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Image /page/4/Picture/0 description: The image shows a logo for Kbiotech. The logo features a stylized letter K with a circular design around it. The word "biotech" is written in bold, italicized letters next to the K. Below the word "biotech" is some text in a different language.
● Indications for Use:
The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®, OneTouch Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.
They are for single patient use only and should not be shared.
They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).
They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The UniStrip1™ Generic Blood Glucose Test Strips allow alternative site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch® Ultra® meter). Alternate site testing should only be done during steady-state times (when glucose is not changing rapidly).
Device Description: ●
The UniStripl Generic Blood Glucose Test Strips are used with the OneTouch® Ultra, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters. The UniStrip1 Generic Blood Glucose Test Strips are intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The UniStrip1 Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch* Ultra* meter). The UniStrip1 Generic Blood Glucose Test Strips can only be used with the OneTouch® Ultra®, OneTouch Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016. UniStripl Generic Blood Glucose Test Strips are only for use with calibration code 49.
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Image /page/5/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter "K" enclosed in a circular shape, followed by the word "biotech" in a bold, sans-serif font. Below the word "biotech" is some text in a different language, possibly Chinese or Japanese.
● Test Principle
The OneTouch® Ultra® Family meters are plasma-calibrated to allow easy comparison of results with laboratory methods. Glucose in the blood sample mixes with special chemicals on the UniStrip1 Generic Blood Glucose Test Strips and a small electrical current is produced. This current is measured by the OneTouch® Ultra® Family Meters and displayed as your blood glucose result. The strength of the current changes with the amount of glucose in the blood sample.
● Comparison Table
| Item | Predicate device | Subject device |
|---|---|---|
| Trade name | UniStrip1 Generic Blood Glucose | |
| Test Strips | UniStrip1 Generic Blood Glucose | |
| Test Strips | ||
| Manufacturer | OK Biotech Co., Ltd. | OK Biotech Co., Ltd. |
| 510(k) No. | K160038 | K162430 |
| Similarities | ||
| Test Principle | Glucose in the blood sample mixes | |
| with glucose oxidase on the | ||
| UniStrip1 test strip and a small | ||
| electrical current is measured by the | ||
| meter(s) and displayed as your blood | ||
| glucose results. The strength of this | ||
| current changes with the amounts of | ||
| glucose in the blood sample. | Same | |
| Enzyme | Glucose oxidase ( Aspergillus niger ) | Same |
| Specimen Type | Capillary whole blood from fingertip | |
| and alternate sites (palm, forearm and | ||
| upper-arm) | ||
| (Use of palm AST is not to be done with | ||
| OneTouch® Ultra® meter). | Same | |
| Sample Volume | 1.0 μL | Same |
| Operating | ||
| Temperature | 43 - 111 °F (6 - 44 °C) | Same |
| Temperature | 10 - 90% R.H. | Same |
| HCT Range | 30 - 55% | Same |
| Detecting Limit | 20 - 600 mg/dL | Same |
| Measuring time | 5 seconds | Same |
| Strip Storage | ||
| Temperature | 39 - 104 °F (4 - 40 °C) | Same |
| Opened test strips | ||
| vial shelf life | 90 days after first opening | Same |
| Unopened test strips | ||
| vial shelf life | 24 months | Same |
| Brand name of | ||
| Control solution | UniStrip Control Solutions | Same |
| Ingredient | ||
| Chemicals of the | ||
| UniStrip1 Generic | ||
| Blood Glucose Test | ||
| Strips | 1. Glucose oxidase (Aspergillus | |
| niger): 20 IU |
- Potassium ferricyanide: 0.12 mg
- Non-reactive ingredients: 1.8 mg | Same |
| Ingredient
Chemicals of the
Control Solutions | 1. D-Glucose - Polyvinyl acetate (aqueous
emulsion): 10% - Antifoaming agent
(Polyethylene Glycol 4000):
0.02% - Disodium EDTA: 0.1%
- Fumed silica: 0.2%
- Food Pigment Red No.6:
0.05% - Sodium Benzoate: 0.2% | Same |
| Differences | | |
| Indications for 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® | 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 |
| 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). | 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). | |
6
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.
-
- 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 http://www.okbiotech.com E-mail:service@okbiotech.com
- Altitude study per ISO 15197:2013 In vitro diagnostic test systems -Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus
| 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% |
-
- 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