(30 days)
Not Found
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No
The device is for the management of diabetes, not treatment. It's a diagnostic tool rather than a therapeutic one.
No
The "Intended Use / Indications for Use" states, "The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus."
No
The description refers to a "Blood Glucose System," which typically includes hardware components like a meter and test strips, and the intended use describes measuring glucose in blood, which requires a physical interaction with a sample.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the quantitative determination of glucose in human capillary whole blood. This involves testing a biological sample (blood) outside of the body to provide information about a person's health status (glucose levels for diabetes management).
- Sample Type: It uses human capillary whole blood, which is a biological specimen.
- Purpose: The purpose is to assist in the management of diabetes, which is a medical condition.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TRUEbalance Blood Glucose System is intended for the quantitative determination of glucose in human capillary 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.
The alternative site (forearm) testing for the TRUEbalance Blood Clucose System can be used only during steady-state blood glucose conditions.
The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus.
Product codes
NBW, CGA
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
Not Found
Anatomical Site
finger or forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient and Healthcare Professional
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
MAR 2 7 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Home Diagnostics Inc. c/o Karen De Vincent Director of Regulatory Affairs/Quality Assurance 2400 NW 55" Court Fort Lauderdale, FL 33309
K090495 Re:
Trade/Device Name: TRUEbalance Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: February 23, 2009 Received: February 25, 2009
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).
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.
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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,
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known):
kogo495
Device Name: TRUEbalance Blood Clucose System
Indication For Use:
The TRUEbalance Blood Glucose System is intended for the quantitative determination of glucose in human capillary 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.
The alternative site (forearm) testing for the TRUEbalance Blood Clucose System can be used only during steady-state blood glucose conditions.
The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus.
Prescription Use _ (21 CFR Part 801 Subpart D)
Over the Counter Use _ X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090495
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