(16 days)
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No
The summary describes a standard blood glucose monitoring system and lacks any mention of AI, ML, image processing, or data sets typically associated with AI/ML-powered devices.
No
The device is used for the quantitative determination of glucose to assist in the management of diabetes, which is a diagnostic and monitoring function, not a therapeutic one. It does not treat or cure a disease.
Yes
The Intended Use section states that the device is "intended for the quantitative determination of glucose in human whole blood" and "is intended to be used to assist the patient and healthcare professional in the management of diabetes," which clearly indicates a diagnostic purpose.
No
The description explicitly states the device is a "Blood Glucose Test System" intended for "quantitative determination of glucose in human whole blood taken from the finger or forearm." This strongly implies the use of hardware components (like a meter and test strips) to perform the blood glucose measurement, which is not characteristic of a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the "quantitative determination of glucose in human whole blood taken from the finger or forearm." This involves testing a biological sample (blood) outside of the body to provide information about a person's health status (glucose levels related to diabetes).
- Sample Type: It specifies the use of "human whole blood," which is a biological specimen.
- Purpose: The purpose is to "assist the patient and healthcare professional in the management of diabetes," which is a medical condition.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The TrackEASE Smart System Blood Glucose Test System is intended for the quantitative I determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Product codes
NBW, JJX
Device Description
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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
finger or forearm
Indicated Patient Age Range
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Intended User / Care Setting
patient and healthcare professional
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the symbol. The caduceus is rendered in a simple, black line drawing, and the text is also in black, creating a clean and recognizable emblem.
Public Health Service
AUG 1 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Karen De Vincent Director of Regulatory Affairs/ Quality Assurance Home Diagnostics, Inc. 2400 NW 55 Ct. Ft. Lauderdale, FL 33309
K042080 Re:
Trade/Device Name: TrackEASE Smart System Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test System Regulatory Class: Class II Product Code: NBW, JJX Dated: July 30, 2004 Received: August 03, 2004
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).
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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, MS, 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): ______K042080
TrackEASE Smart System Blood Glucose Test System Device Name:
Indications For Use:
The TrackEASE Smart System Blood Glucose Test System is intended for the quantitative I determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ......................................................................................................................................................... X_____________________________________________________________________________________________________________________________________________________________________________ (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)
Carol C. Benson
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510K).
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