(66 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is not available to provide further clues.
No
The device is a data management software intended to assist in the review, analysis, and evaluation of blood glucose test results to support diabetes management. It does not directly treat or prevent a disease, injury, or condition.
Yes
The software assists in the "review, analysis and evaluation of historical blood glucose test results" to "support effective diabetes management," which implies it aids in understanding a patient's condition to make informed decisions about their health. This falls within the scope of diagnosis or monitoring for diagnostic purposes.
Yes
The device is described as "TrackRecord Data Management Software" and its intended use is solely for the review, analysis, and evaluation of historical blood glucose test results. There is no mention of any accompanying hardware or physical components.
Based on the provided information, the TrackRecord Data Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software is intended to assist in the review, analysis, and evaluation of historical blood glucose test results. It does not perform the diagnostic test itself (measuring blood glucose). The blood glucose test is the IVD.
- Function: The software is a data management tool. It takes data generated by an IVD (the blood glucose meter) and helps users and healthcare professionals understand that data. It doesn't directly interact with biological samples or perform a diagnostic measurement.
IVDs are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The TrackRecord software operates on the results of such tests, not on the specimens themselves.
N/A
Intended Use / Indications for Use
TrackRecord Data Management Software is intended for use in the home or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.
Product codes
NBW, JQP
Device Description
Not Found
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 or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design, with three stylized lines forming the body and wings of the eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 7 2007
Home Diagnostics, Inc. c/o Ms. Karen DeVincent Regulatory Affairs, Quality Assurance 2400 N.W. 55th Court Fort Lauderdale, F1 33309
K070593 Re:
Trade/Device Name: Track Record Data Management Software Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: February 28, 2007 Received: March 02, 2007
Dear Ms. DeVincent:
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).
1
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 1 legal/y marketed predicate device results in a classification for your device and thus, perroits 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 tollofren mber (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.
Jean 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
2
Indications for Use
16070593 510(k) Number (if known):_
Device Name:
Indications For Use:
TrackRecord Data Management Software is intended for use in the home or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 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)
Sign-Off
In Vitro Diagnostic Device
and Safety
1070593
Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________