(744 days)
Not Found
No
The document describes a blood glucose test strip and its compatibility with specific meters. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is standard electrochemical glucose measurement.
No.
The device is an in vitro diagnostic (IVD) product used for measuring glucose levels, which aids in monitoring diabetes control but does not directly treat or cure the condition.
Yes
Explanation: The device is used for measuring glucose in whole capillary blood, which is a diagnostic measurement. Although it states "Not intended for the diagnosis of or screening for diabetes mellitus," it is used "as an aid to monitor the effectiveness of diabetes control," which falls under the broader definition of a diagnostic device by providing information for managing a medical condition. It also explicitly states "in vitro diagnostic use."
No
The device described is a test strip, which is a physical component used in conjunction with a blood glucose meter. It is an in vitro diagnostic device and not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (in vitro diagnostic use)."
Furthermore, the "Device Description" section also reiterates: "The UniStrip1™ Test Strips is intended for use outside the body (in vitro diagnostic use)..."
These statements clearly indicate that the device is designed to perform tests on samples taken from the human body, but the testing itself is conducted outside the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Unistrip1™ Test Strips are used with the OneTouch "Ultra", OneTouch" Ultra2", 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™ 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 should only be done during steady-state times (when glucose is not changing rapidly). Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
Product codes
NBW, CGA
Device Description
The UniStrip1™ Test Strips are used with the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraMini® and QneTouch® UltraSmart® blood glucose monitoring systems. The UniStrip1™ test Strips is intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The 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).
The UniStrip1™ Test Strip can only be used on the OneTouch®Ultra®, OneTouch®Ultra2®, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before October 2012. UniStrip1™ 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
fingertip, palm and/or the forearm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
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)
Non-Clinical:
The following tests and studies were conducted to ensure the UniStrip1™ Test Strips were safe and effective when using the UniStrip1™ Test Strip with the following blood glucose meters -OneTouch®Ultra®, OneTouch®Ultra2®, OneTouch® UltraMini® and One-Touch® UltraSmart®.
0 NCCLS EP5-A Precision Test
0 NCCLS EP6-A Linearity Test
ඹ ISO 15971 and EP7-A2 Interference Tests
₪ ISO 15971 System Accuracy Evaluation
₪ ISO 15971 and ISO 5725-1 Comparison Test
0 ISO 15971 Altitude Test
@ Volume Verification Study
₪ EN 13640 Operation Conditions Tests for Test Strip
@ EN 13640 Storage Conditions Test for Test Strip
@ ISO 15971 Control Solution test
ISO 159712 and ISO 5725-1 User Evaluation
@ Error Code Comparison Tests
Clinical Studies: No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K11313:5
510(k) Summary
A summary of 510k safety and effectiveness information in accordance with 21 CFR 807.92
| Date Prepared: | November 5, 2013 |
|---|---|
| Sponsor Information: | UniStrip Technologies, LLC. |
| Sponsor Address: | 2701-A Hutchison McDonald Road |
| Charlotte, NC 28269 | |
| Sponsor Contact: | Richard Admani |
| Sponsor Tel Number: | 1-704-285-6400 |
| Sponsor Fax Number: | 1-704-285-6495 |
| Device Name: | UniStrip1™ Test Strips |
| Common/Usual Name: | Blood Glucose Test Strips |
| Classification Name: | Glucose, Oxidase, Glucose |
| Regulation Number: | 21 CFR 862.1345 |
| Product Code: | NBW, CGA |
| Device Class: | Class II |
| Review Panel: | Clinical Chemistry |
NOV 062013
Predicate Device: Manufacturer
Lifescan, Inc.
| Brand Name |
|---|
| OneTouch® Test Strips |
510(k) Number K923544
Device Description
The UniStrip1™ Test Strips are used with the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraMini® and QneTouch® UltraSmart® blood glucose monitoring systems. The UniStrip1™ test Strips is intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The 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).
The UniStrip1™ Test Strip can only be used on the OneTouch®Ultra®, OneTouch®Ultra2®, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before October 2012. UniStrip1™ Test Strips are only for use with calibration code 49.
Indications for Use
The Unistrip1™ Test Strips are used with the OneTouch "Ultra", OneTouch" Ultra2", 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™ 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.
1
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 should only be done during steady-state times (when glucose is not changing rapidly). Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
| Similarities to Predicate Device | ||
|---|---|---|
| Characteristic | Predicate Device | New Device |
| Reagent Composition | Glucose Oxidase (Aspergillus niger) | Same as predicate |
| Specimen Type | Fresh capillary whole blood | Same as predicate |
| Sample Volume | 1.0 µL | Same as predicate |
| Control Solution | Use OneTouch Ultra Control Solution | Use Prodigy Control Solution |
| Detecting Range | 20-600 mg/dL | Same as predicate |
| Calibration | Various codes | Code 49 Only |
| Altitude Use | Up to 10,000 feet | Same as predicate |
| Storage Temperature | Less than 86°F (30° C) | 39°-86°F (4°-30°C) |
| Open Vial Shelf Life | 6 months after opening | 90 days after opening |
Predicate Product Comparison Similarities to Predicate Device
Differences with Predicate Device
| Characteristic | Predicate Device | New Device |
|---|---|---|
| Control Solution | Use OneTouch Ultra Control Solution | Use Prodigy Control Solution |
| Calibration | Various codes | Code 49 Only |
| Storage Temperature | Less than 86°F (30° C) | 39°-86°F (4°-30°C) |
| Open Vial Shelf Life | 6 months after opening | 90 days after opening |
Safety and Effectiveness Tests and Studies Non-Clinical
The following tests and studies were conducted to ensure the UniStrip1™ Test Strips were safe and effective when using the UniStrip1™ Test Strip with the following blood glucose meters -OneTouch®Ultra®, OneTouch®Ultra2®, OneTouch® UltraMini® and One-Touch® UltraSmart®.
0 NCCLS EP5-A Precision Test
0 NCCLS EP6-A Linearity Test
ඹ ISO 15971 and EP7-A2 Interference Tests
₪ ISO 15971 System Accuracy Evaluation
₪ ISO 15971 and ISO 5725-1 Comparison Test
0 ISO 15971 Altitude Test
@ Volume Verification Study
₪ EN 13640 Operation Conditions Tests for Test Strip
@ EN 13640 Storage Conditions Test for Test Strip
@ ISO 15971 Control Solution test
ISO 159712 and ISO 5725-1 User Evaluation
@ Error Code Comparison Tests
2
Clinical Studies No clinical studies were conducted.
Conclusion
Based on the Predicate Product Comparison Table of similarities, standard and FDA guidance tests and study results UniStrip Technologies, LLC concludes that no new issues of safety and effective have been raised in this original 510(k) submission for the UniStrip1™ Test Strips to be used with the OneTouch®Ultra®, OneTouch®Ultra2®, OneTouch® UltraMini® and One-Touch® UltraSmart® blood glucose meters purchased before October 2012.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wave-like lines below the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2013
UniStrip Technologies, LLC Richard Admani Chief Operations Officer 2701-A Hutchison McDonald Rd. . CHARLOTTE, NC 28269
Re: K113135
Trade/Device Name: UniStrip I Test Strip Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: November 01, 2013 Received: November 04, 2013
Dear Mr. Admani:
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. Iisting 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.
4
Page 2-Mr. Admani
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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.hum.
Sincerely yours,
Carol C. Benson -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
5
Indications for Use
510(k) Number (if known): K113135
Device Name: UniStrip1 Test Strip
Indications for Use:
The Unistrip 1 Test Strips are used with the OneTouch® Ultra®, OneTouch®Ultra2®, 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 Unistrip I is meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.
Thev 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 should only be done during steady-state times (when glucose is not changing rapidly).
Over-The-Counter Use AND/OR x Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Stayce Beck
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)
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