(166 days)
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No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
This device is for monitoring blood glucose levels to assist in diabetes management, which is diagnostic/monitoring, not therapeutic.
Yes
The device is intended for the quantitative determination of glucose in human whole blood to assist in the management of diabetes, which involves diagnosing and monitoring a medical condition.
No
The device description explicitly states "TRUEresult Blood Glucose Monitoring System," which is a system that includes hardware (a blood glucose meter) for measuring glucose levels. The summary does not indicate that the submission is solely for software that processes data from a separate, pre-existing hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "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 obtain diagnostic information (glucose levels).
- Nature of the Test: Measuring glucose levels in blood is a classic example of an in vitro diagnostic test used to manage a medical condition (diabetes).
- Target User: The device is intended for both patients and Healthcare Professionals, which is common for IVD devices used for monitoring and management.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The TRUEresult Blood Glucose System is intended for the quantitative 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. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.
Product codes
NBW, LFR
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 (for whole blood samples)
Indicated Patient Age Range
Not for neonatal use.
Intended User / Care Setting
patient and Healthcare Professional; home-use is limited to capillary whole blood testing.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a logo with a stylized depiction of a bird in flight. The bird is composed of three curved lines that suggest movement and feathers. The logo is encircled by text, which is arranged in a circular pattern around the bird. The text is small and difficult to read, but it appears to be part of the organization's name or a related phrase.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Home Diagnostics, Inc. c/o Ms. Karen DeVincent Director of Regulatory Affairs Quality Assurance 2400 N.W. 55th Court Fort Lauderdale, FL 33309
AUG 1 9 2008
Re: K080641
Trade/Device Name: TRUEresult Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Codes: NBW, LFR Dated: August 11, 2008 Received: August 13, 2008
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 (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.
Yean 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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510(k) Number (if known): K080641
Device Name: TRUEresult Blood Glucose Monitoring System
Indications for Use:
The TRUEresult Blood Glucose System is intended for the quantitative 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.
Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing.
Not for neonatal use.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVID)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
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