(543 days)
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No
The provided text describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No.
The device is used to monitor an aid for diabetes control, not to actively treat or modify a physiological process. It is an in vitro diagnostic device used for measurement.
No.
The device is intended for monitoring the effectiveness of diabetes control, not for the screening or diagnosis of diabetes.
No
The device description explicitly mentions a "Blood Glucose Monitoring System" which includes a "Blood Glucose Meter" and "Blood Glucose Test Strips." These are hardware components, not software-only.
Yes, based on the provided text, the Diacheck Premium Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The system is intended for self testing outside the body (in vitro diagnostic use)." and "The test strip is intended for self testing outside the bod (in vitro diagnostic use)."
This direct statement confirms its classification as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Diacheck Premium Blood Glucose Monitoring System:
The Diacheck Premium Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
The Diacheck Premium Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.
Diacheck Premium Blood Glucose Test Strips:
The Diacheck Premium Blood Glucose Test Strips are for use with the Diacheck Premium Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The test strip is intended for self testing outside the bod (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.
Diacheck Glucose Control Solution:
The Diacheck Control solutions are intended for use with Diacheck Premium Blood Glucose Meter and Diacheck Premium Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, 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
Fingertips
Indicated Patient Age Range
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Intended User / Care Setting
People with diabetes at home / self 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/0/Picture/4 description: The image shows a date stamp that reads 'SEP 16 2011'. The letters and numbers are in a bold, sans-serif font. The stamp appears to be slightly faded or worn, giving it a vintage look.
DELBio Incorporation c/o Ms. Nicky Pan Regulatory Affairs Specialist 3F. No. 252 Shangying Road, Guishan Industrial Zone. Taoyuan County, Taiwan 33341
Re: K100806
Trade/Device Name: DiaCheck Premium Blood Glucose Monitor System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: September 12. 2011 Received: September 12, 2011
Dear Ms. Pan:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours.
signature
Courtney H. Lias, Ph.D. 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): K100806
Device Name: DiaCheck Premium Blood Glucose Monitoring System
Indication for Use:
Diacheck Premium Blood Glucose Monitoring System:
The Diacheck Premium Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
The Diacheck Premium Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.
Diacheck Premium Blood Glucose Test Strips:
The Diacheck Premium Blood Glucose Test Strips are for use with the Diacheck Premium Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The test strip is intended for self testing outside the bod (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.
Diacheck Glucose Control Solution:
The Diacheck Control solutions are intended for use with Diacheck Premium Blood Glucose Meter and Diacheck Premium Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use X (21 CFR Part 801 Subpart C)
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And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Butte Charles
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 00 fo 6