(28 days)
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Not Found
No
The description focuses on data retrieval, trending, and reporting, with no mention of AI or ML technologies.
No
The device aids in the review, analysis, and evaluation of historical blood glucose results to support effective diabetes management, but it does not directly treat or diagnose a disease.
No
Explanation: The device is described as a "Diabetes Management Program" intended for the "review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management." It is an accessory to blood glucose monitoring systems and provides trending and reports, which are functions related to managing and monitoring a condition rather than diagnosing one.
Yes
The device is described as a web-based application and a stand-alone software driver, with no mention of accompanying hardware components that are part of the regulated device itself. It functions by retrieving and processing data from external sources (blood glucose meters and HealthVault).
Based on the provided information, the OneTouch® Zoom™ Diabetes Management Program is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management." It is explicitly stated as an "accessory to LifeScan blood glucose monitoring systems."
- Device Description: It's described as a "web-based application" and "stand-alone software driver" that retrieves, trends, and reports on already obtained blood glucose data.
- Lack of Direct Measurement: IVD devices are used to perform tests on specimens (like blood, urine, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device does not perform any such test or measurement itself. It processes data generated by a separate device (the blood glucose meter).
In essence, the OneTouch® Zoom™ Diabetes Management Program is a data management and analysis tool for information gathered by an IVD (the blood glucose meter), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The ONE Touch® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
Device Description
The OneTouch® Zoom™ Diabetes Management Program is a web-based application that is designed to retrieve blood glucose data from the Microsoft® HealthVault™ and provide trending and reports in order to assist people with diabetes management.
The program also includes a stand-alone software driver, branded as OneTouch® Meter Drivers for use with Microsoft® HealthVault™ that downloads blood glucose data from Lifescan Brand blood glucose meters with data management capabilities to Microsoft® HealthVault™ Connection Center, which subsequently upload the data to the user's online Microsoft® HealthVault™ account.
The OneTouch® Zoom™ Diabetes Management Program is a .NET based client/server application that runs on Windows 2003 server and supports Internet Explorer 6.0 and higher on the client side.
The OneTouch® Meter Drivers for use with Microsoft® HealthVault™ run on Windows XP Service Pack 2 and Windows Vista platforms.
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
home and clinical settings to aid people with diabetes and healthcare professionals
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Zoom™ Diabetes Management Program was equivalent to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
OneTouch® Diabetes Management Software
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Special 510(k)
JUN - 9 2008
OneTouch® Zoom™ Diabetes Management Program
510(k) Summary
Sponsor LifeScan, Inc. 1000 Gibraltar Drive
Milpitas, CA 95035 U.S.A.
Correspondent
Primary 510(k) Contact: Frank Peralta LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
Phone: 408.942.3588 e-mail: fperalta@lfsus.jnj.com
Alternate 510(k) Contact: Mary Ellen Holden LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
Phone: 408.942.3589 E-mail: mholden@lfsus.jnj.com
Device Name and Classification
OneTouch® Zoom™ Diabetes Management Program Common name: Glucose test system Classification: OneTouch® Zoom™ Diabetes Management Programa Class II device (21 CFR § 862.1345)
1
Product Description
The OneTouch® Zoom™ Diabetes Management Program is a web-based application that is designed to retrieve blood glucose data from the Microsoft® HealthVault™ and provide trending and reports in order to assist people with diabetes management.
The program also includes a stand-alone software driver, branded as OneTouch® Meter Drivers for use with Microsoft® HealthVault™ that downloads blood glucose data from Lifescan Brand blood glucose meters with data management capabilities to Microsoft® HealthVault™ Connection Center, which subsequently upload the data to the user's online Microsoft® HealthVault™ account.
The OneTouch® Zoom™ Diabetes Management Program is a .NET based client/server application that runs on Windows 2003 server and supports Internet Explorer 6.0 and higher on the client side.
The OneTouch® Meter Drivers for use with Microsoft® HealthVault™ run on Windows XP Service Pack 2 and Windows Vista platforms.
Predicate Device
OneTouch® Diabetes Management Software
Intended Use
The ONE TOUCH® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.
Comparison to Predicate Device
The modifications to the device encompass:
- . Reports: a reduction in the number of reports from eleven to two.
- . Data Storage: a change in data storage on a local database stored on the user's PC to a remote database hosted by Microsoft Corporation. connected via the Internet.
2
OneTouch® Zoom™ Diabetes Management Program
There has been no change to the intended use, operating principle, functionality, or material composition of the device.
Technological Characteristics
There has been no change to the fundamental scientific technology.
Summary of Performance Characteristics
There has been no change to the performance characteristics of the product.
Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Zoom™ Diabetes Management Program was equivalent to that of the predicate device.
Conclusion
The OneTouch® Zoom™ Diabetes Management Program is substantially equivalent to the predicate OneTouch Diabetes Management Software.
3
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 9 2008
LifeScan, Inc. Mr. Frank Peralta Senior Regulatory Submissions Specialist 1000 Gibraltar Drive Milpitas, CA, 95035-6312
Re: K081318
Trade/Device Name: OneTouch® Zoom™ Diabetes Management Program Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: May 9, 2008 Received: May 12, 2008
Dear Mr. Peralta:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
ONE TOUCH® Zoom™ Diabetes Management Program Device Name:
Indications for Use:
The ONE Touch® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.
| Prescription Use | |
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| (Per 21 CFR 801 Subpart D) |
AND/OR
Over-the-Counter Use__
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