(80 days)
Not Found
No
The summary describes a standard blood glucose monitoring system with electronic logbook functions and data download capabilities. There is no mention of AI, ML, or any features that would suggest the use of such technologies for data analysis, prediction, or interpretation beyond basic storage and display. The performance studies compare it to previous versions of the same type of device, not devices with advanced analytical capabilities.
No
The device is an in vitro diagnostic device used to measure glucose, not to directly treat a condition. While it aids in monitoring diabetes control, it does not provide therapeutic action itself.
Yes
The device is intended for the quantitative measurement of glucose in fresh capillary whole blood, which is used as an aid to monitor the effectiveness of diabetes control. The "intended for in vitro diagnostic use" statement further confirms its diagnostic purpose.
No
The device description explicitly lists multiple hardware components including a meter, test strips, control solution, lancing device, cap, and lancets, in addition to the electronic logbook functions.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "The One Touch® UltraSmart™ System is intended for use outside the body (for in vitro diagnostic use)..."
- Measurement of Analytes: The device is designed to quantitatively measure glucose in fresh capillary whole blood, which is a biological sample.
- Purpose: The purpose is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose related to a medical condition.
The device description further supports this by detailing the components used to perform the in vitro diagnostic test (meter, test strips, control solution).
N/A
Intended Use / Indications for Use
The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart™ System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The One Touch® UltraSmart™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.
Product codes
NBW
Device Description
The One Touch® UltraSmart™ System consists of the One Touch® UltraSmart™ Meter, One Touch® Ultra™ Test Strips, One Touch® Ultra™ Control Solution, UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ lancets. The One Touch® UltraSmart™ Meter, when used with the One Touch® Ultra™ Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The One Touch® Ultra™ Control Solution verifies the performance of the One Touch® Ultra™ Blood Glucose Test Strips.
The UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ lancets are provided to facilitate obtaining a capillary blood sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
people with diabetes at home and by health care professionals in a clinical setting
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)
Laboratory studies and clinical studies demonstrate that the One Touch® UltraSmart™ Blood Glucose System provides equivalent performance to the One Touch® Ultra™ Blood Glucose System.
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
510(k) SUMMARY
(As required by 21 C.F.R. § 807.92)
| (As required by 21 C.F.R. § 807.92) | |
|---|---|
| K021819 | |
| Submitted By: | Lifescan, Inc. |
| 1000 Gibraltar Drive | |
| Milpitas, CA 95035 | |
| Contact Person: | Mary Ellen Holden |
| Senior Regulatory Affairs Specialist | |
| Lifescan, Inc. | |
| Date Summary | Phone: (408) 942-3589 |
| Fax: (408) 942-5906 | |
| E-mail: mholden@lfsus.jnj.com | |
| June 3, 2002 | |
| Prepared: | |
| Device Name: | One Touch® UltraSmart™ Blood Glucose Monitoring System |
| Classification | |
| Names: | (1) The One Touch® UltraSmart™ Meter and ONE TOUCH® |
| Ultra™ Test Strip are Class II devices (21 CFR § 862.1345, | |
| Glucose Monitor). | |
| (2) One Touch® Ultra™ Control Solution is a Class I device (21 | |
| CFR § 862.1660, Single Analyte Control). | |
| (3) Sterile lancet, Lancing Device and accessories are Class I | |
| (exempt) devices (21 CFR § 878.4800, Lancet, Blood). | |
| Substantial | |
| Equivalence: | The One Touch® UltraSmart™ Blood Glucose Monitoring System is |
| substantially equivalent to the previously cleared One Touch® | |
| Ultra™ Blood Glucose Monitoring System (K002134), in that both | |
| devices are intended for the quantitative measurement of glucose in | |
| capillary whole blood (for in vitro diagnostic use) by people with | |
| diabetes and healthcare professionals. Both devices use the | |
| identical method of glucose detection and have the same safety and | |
| effectiveness. In addition, it is substantially equivalent to the One | |
| Touch® Profile® (K950727) Blood Glucose Monitoring System, a | |
| predicate device with similar advanced memory features | |
| Description of the | |
| Device: | The One Touch® UltraSmart™ System consists of the One Touch® |
| UltraSmart™ Meter, One Touch® Ultra™ Test Strips, One Touch® | |
| Ultra™ Control Solution, UltraSoft™ Lancing Device, UltraClear™ | |
| cap and UltraSoft™ lancets. The One Touch® UltraSmart™ Meter, | |
| when used with the One Touch® Ultra™ Blood Glucose Test Strips, | |
| quantitatively measures glucose in capillary whole blood. The One | |
| Touch® Ultra™ Control Solution verifies the performance of the | |
| One Touch® Ultra™ Blood Glucose Test Strips. | |
| The UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ | |
| lancets are provided to facilitate obtaining a capillary blood sample. | |
| Statement of | |
| Intended Use: | The One Touch® UltraSmart™ Blood Glucose Monitoring System is |
| intended to be used for the quantitative measurement of glucose in | |
| fresh capillary whole blood. The One Touch® UltraSmart™ System | |
| is intended for use outside the body (for in vitro diagnostic use) by | |
| people with diabetes at home and by health care professionals in a | |
| clinical setting as an aid to monitor the effectiveness of diabetes | |
| control. | |
| The One Touch® UltraSmart™ Blood Glucose Monitoring System | |
| provides the user with electronic logbook functions that store data | |
| such as insulin and oral medication doses, food intake, amount of | |
| exercise, and health information such as illnesses. The meter | |
| includes a data port that enables the user to download electronic | |
| logbook data to a personal computer | |
| Description of | |
| Similarities and | |
| Differences: | The One Touch® UltraSmart™ System, provides the same glucose |
| monitoring capability as the predicate device, the One Touch® | |
| Ultra™ System (K002134). One Touch® UltraSmart™ and One | |
| Touch® Ultra™ are essentially identical from the perspective of | |
| measuring glucose. In fact, they use the same One Touch Ultra™ | |
| test strip. The primary differences are in the advanced memory | |
| features. In this respect, the One Touch® UltraSmart™ System adds | |
| electronic logbook features similar to those offered commercially | |
| by the One Touch® Profile Meter (K950727). | |
| The advanced memory features of One Touch® UltraSmart™ are | |
| similar to those of the One Touch® Profile Meter previously cleared | |
| for market (K950727). The One Touch® UltraSmart™ meter offers | |
| more memory, which allows advanced features not available with | |
| the predicate devices. The increased data storage expanded | |
| memory offers more opportunities to people with diabetes in | |
| managing their diabetes. | |
| Summary of | |
| Performance Data | Laboratory studies and clinical studies demonstrate that the One |
| Touch® UltraSmart™ Blood Glucose System provides equivalent | |
| performance to the One Touch® Ultra™ Blood Glucose System. |
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2002
Ms. Mary Ellen Holden Sr. Regulatory Affairs Specialist LifeScan. Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
K021819 Re: Trade/Device Name: ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 3, 2002 Received: June 4, 2002
Dear Ms. Holden:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); 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.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.0 ODE INDICATIONS FOR USE STATEMENT
Indications for Use Statement
| 510(k) Number: | K021819 |
|---|---|
| Device Name: | ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System |
Indications for Use:
The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart" System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The One Touch® UltraSmari™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ------------------------------------ |
Carol C Benson for Jean Cooper, DVM
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | KO21819 |
|---|---|
| --------------- | --------- |
ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System