(78 days)
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No
The description focuses on data transfer and basic data management (review, analysis, evaluation of historical results), with no mention of AI/ML terms or capabilities like prediction, pattern recognition beyond simple analysis, or learning from data.
No
The device is a software accessory that aids in reviewing, analyzing, and evaluating historical test results for data management, rather than actively treating or preventing a disease.
No
The software aids users and healthcare professionals in reviewing, analyzing, and evaluating historical test results from other medical devices, but it does not independently generate a diagnosis. Its purpose is data management and evaluation of existing test results, not to diagnose a condition itself.
Yes
The device is described as "software accessory" and its function is data transfer and management from existing hardware devices (blood glucose meters and blood pressure monitors) to a computer. The performance studies mention "validation of hardware (data transfer through the cable)" but this refers to the interface with the hardware, not the software itself being a hardware component. The core function is software-based data handling.
Based on the provided information, the Clever Chek Health Care System Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Clever Chek Software's Function: The software's primary function is to transfer, manage, review, analyze, and evaluate historical test results obtained from other devices (blood glucose meters and blood pressure monitors). It does not perform any in vitro testing itself. It processes data that has already been generated by an IVD (the blood glucose meter) or a non-IVD (the blood pressure monitor).
- Intended Use: The intended use clearly states it's an "aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively." This is a data management and analysis function, not an in vitro diagnostic test.
While the software works with data from a blood glucose meter (which is an IVD), the software itself is a tool for managing and interpreting that data, not for performing the diagnostic test.
N/A
Intended Use / Indications for Use
The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.
Product codes
NBW, DXN
Device Description
The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a)Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
home and clinical settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Testing of Clever Chek Health Care System Software included validation of hardware (data transfer through the cable) software and user evaluation. It demonstrated that the system meets its intended use.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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510 (k) Summary
JUN 2 1 2007
Page 1-of-2
- Submitter Information Company name Contact person Address
Phone FAX E-mail Date Prepared
- Name of Device Trade Names
Common Names Classification Names and Regulations
TaiDoc Technology Corporation Erica Li 4F, No. 88, Sec. 1, Kwang-Fu Rd, San-Chung, Taipei County, 241, Taiwan (886-2) 6635-8080 (886-2) 6635-5959 erica@taidoc.com Mar 30th , 2007
Clever Chek Health Care System Software Data management software
a) Calculator/data processing module for clinical use, Class I, 21CFR862.2100 b) Glucose Test System, Class II, 21CFR862.1345 c) Noninvasive Blood Pressure Measurement System, Class II, 21CFR870.1130,
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number
Camit Diabetes Management Software Data management software Roche Diagnostics Corporation K001907
1
4. Device Description
The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a)Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
5. Intended Use
The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for people with diabetes and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.
6. Comparison to Predicate Device
The Clever Chek Health Care System Software is substantially equivalent to the Camit Diabetes Management Software (K001907). Both management software programs can be described as follows:
-
have the same intended use.
-
data transferred from the device cannot be changed or modified in any way.
7. Performance Studies
Testing of Clever Chek Health Care System Software included validation of hardware (data transfer through the cable) software and user evaluation. It demonstrated that the system meets its intended use.
8. Conclusion
Clever Chek Health Care System Software demonstrates satisfactory performance and is suitable for its intended use.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
TaiDoc Technology Corporation c/o Ms. Erica (Pi-Shiou) Li Management Representative 4F, No. 88, Sec. 1, Kwang-Fu Rd. San-Chung, Taipei County Taiwan 241
JUN 2 1 2007
K070941 Trade/Device Name: Clever Chek Health Care System Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, DXN Dated: March 30, 2007 Received: April 04, 2007
Dear Ms. Li:
Re:
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. Ilsting 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).
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mains of substantial equivalence of your device to a legally promarket notification - 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, If you desire specific intoniation actuation of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0490. Also, please note the V III Diagnostic Dones Bradian by reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the 1 ou may oounn only. Echerational 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: K070941
Device Name: Clever Chek Health Care System Software
Indications for Use:
The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.
AND/OR
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CL
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Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) k07099