(69 days)
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Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is for a standard blood glucose test system.
Yes
The device is intended to assist in the management of diabetes, which is a therapeutic purpose.
Yes
The device is described as assisting in the management of diabetes through the quantitative determination of blood glucose, which is a diagnostic function.
No
The description clearly states "Blood Glucose Test System" and mentions taking blood from the finger or forearm, indicating a hardware component for blood collection and analysis, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of blood taken from the finger or forearm." This involves testing a biological sample (blood) outside of the body to obtain a quantitative result.
- Purpose: The system is intended "to be used to assist the patient and healthcare professional in the management of diabetes." This is a medical purpose related to diagnosing, monitoring, or managing a disease.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sidekick Blood Glucose Test System is intended for the quantitative determination The Glookin' 2100a Diole 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
Device Description
Sidekick Blood Glucose Test System
Mentions image processing
Not Found
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)
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
JUL 1 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Karen DeVincent Director of Regulatory Affairs/ Quality Assurance Home Diagnostics, Inc. 2400 NW 55th Court Fort Lauderdale, FL 33309
K051147 Re:
Trade/Device Name: Sidekick Blood Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 20, 2005 Received: June 21, 2005
Dear Ms. DeVincent:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have rowe 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 premained netiretine 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) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting 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
510(k) Number (if known):__K051147
Device Name: _ Sidekick Blood Glucose Test System
Indications For Use:
The Sidekick Blood Glucose Test System is intended for the quantitative determination The Glookin' 2100a Diole 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
X Over-The-Counter Use (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)
Albert G
Division Sign Off
ivision Sign-C
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051147