(204 days)
Not Found
No
The summary describes a standard blood glucose test strip and its performance characteristics, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is a diagnostic tool that measures glucose levels, which aids in monitoring diabetes control. It does not directly treat or provide therapy.
Yes
The device is described as measuring glucose (sugar) in whole capillary blood as an aid to monitor the effectiveness of diabetes control, which is a diagnostic purpose. It explicitly states "Testing is done outside the body (in vitro diagnostic use)." and "Not intended for the diagnosis of or screening for diabetes mellitus", further clarifying its role in monitoring, which is a diagnostic activity post-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 requires a physical sample of blood and chemical reactions on the strip to measure glucose levels. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "Testing is done outside the body (in vitro diagnostic use)."
- "The test strips are intended for use outside the body (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, 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
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.
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 by people with diabetes in their 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)
- Sample volume study per ISO 15197:2013: The glucose measurements of sample volume from 1.0 to 1.5 µL met acceptance criteria, requiring at least 1.0 µL for normal testing.
- Operation condition study per EN 23640:2013: Evaluated performance in normal and extreme environments (42-111 °F (6-44°C), 10-90% R.H.). Individual bias was within ±10 mg/dL for glucose 75 mg/dL compared to Glucose Analyzer YSI 2300.
- Precision study per NCCLS/CLSI EP05-A3:2015: Pooled and maximum SD less than 5.0 mg/dL for glucose 0.95; bias of individual glucose results within ± 10 mg/dL (glucose 75 mg/dL).
- Precision Study: pooled and maximum SD
§ 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.
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 (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
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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 : 886-3-5160258 FAX : 886-3-5160028 China: TEL:86-791-3899362 FAX:86-791-3880131
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 | |
| Owner Number | 9090860 |
| Date prepared | July 29, 2016 |
| Official Correspondent | Dr. JEN, KE-MIN |
| TEL: 886-3-5208829 | |
| FAX: 886-3-5209783 | |
| Email: ceirs.jen@msa.hinet.net | |
| Preference For Continued | |
| 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 | |
| (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: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 trade | ||
| name | UniStrip1™ Test Strips | UniStrip1 Generic Blood Glucose |
| Test Strips | ||
| 510(k) number | K113135 | K160038 |
| Common name | Blood Glucose Test Strips | Blood Glucose Test Strips |
| Classification | ||
| name | System, Test, Blood Glucose, Over | |
| The Counter | System, Test, Blood Glucose, Over | |
| The Counter | ||
| Regulation | ||
| Description | Glucose, Oxidase, Glucose | Glucose, Oxidase, Glucose |
| Product code | NBW, CGA | NBW, CGA, JJX |
| Regulation | ||
| 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 | |
| are plasma-calibrated to allow easy | ||
| comparison of results with laboratory | ||
| methods. Glucose in the blood sample | ||
| mixes with special chemicals on the | ||
| UniStrip1 Test Strips and a small | Same test principle | |
| 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. | ||
| Enzyme | Glucose oxidase (Aspergillus niger) | Same enzyme |
| Specimen Type | Capillary whole blood from fingertip | |
| and alternative sites palm, forearm. | ||
| (Use of palm AST is not to be done | ||
| with OneTouch® Ultra® meter). | Same specimen type | |
| Sample Volume | 1.0 µL | Same sample volume |
| Operating | ||
| Temperature | 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 shelf | ||
| life | 90 days after opening | Same open vial shelf life |
| Chemical | ||
| makeup of test | ||
| strips | 1. Glucose oxidase (Aspergillus niger): | |
| 20 IU |
- Potassium ferricyanide: 0.12 mg
- Non-reactive ingredients: 1.8 mg | Same chemical makeup of test strips |
| | 510(k) cleared as K060467 | |
| Chemical
makeup of
control solution | 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 chemical makeup of control
solution as K060467 |
| Differences: | | |
| Item | Predicate device | Subject device |
| Indications for
use | The UniStrip1 Test Strips are used
with the OneTouch® Ultra®,
OneTouch® Ultra®2, OneTouch®
UltraMini® and One-Touch®
UltraSmart® meters
purchased before October 2012, set at
calibration code 49, for measuring
glucose (sugar) in whole capillary
blood. The Unistrip1 TM is 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 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 (AST) should only be done
during steady-state times (when
glucose is not changing rapidly). | 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. |
| Strip Storage
Temperature | 39 °F – 86 °F
(4°C – 30 °C) | 39 °F – 104 °F
(4 °C – 40 °C) |
| Brand name of
Control solution | Prodigy Control Solution (K060467) | UniStrip Control Solution
(same as K060467) |
6
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.
E-mail:service@okbiotech.com
7
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
8
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.
-
- 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.
- 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
-
- 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 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.
- Operation condition study per EN 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
| 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:
-
- 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
- Precision study per NCCLS/CLSI EP05-A3:2015 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline- Third Edition (FDA recognition number 7-251)