(190 days)
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No.
The device is for monitoring glucose levels as "an aid to monitor the effectiveness of diabetes control," not for treating or providing therapy.
No
The document explicitly states: "The GLUCOCARD® Vital™ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus..." Its purpose is to monitor the effectiveness of diabetes control, not to diagnose the condition.
No
The device description explicitly states that the system consists of a meter, test strips, and control solution, which are all hardware components.
Yes, the provided text explicitly states that the GLUCOCARD® Vital™ Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section clearly says: "Testing is done outside the body (In Vitro diagnostic use)."
N/A
Intended Use / Indications for Use
The GLUCOCARD® Vital™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The GLUCOCARD® Vital™ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
GLUCOCARD® Vital™ Blood Glucose Meter: The GLUCOCARD® Vital™ Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
GLUCOCARD® Vital™ Blood Glucose Test Strips: GLUCOCARD® Vital™ test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms when used with the GLUCOCARD® Vital™ Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter (OTC)) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure Dose CONTROL: For use with GLUCOCARD® Vital™ Blood Glucose Meter and GLUCOCARD® Vital™ Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Level 1 (Normal) and Level 2 (High),
Product codes
CGA, NBW, JJX
Device Description
The GLUCOCARD® Vital™ Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips and palms
Indicated Patient Age Range
not intended for use on neonates
Intended User / Care Setting
at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals
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
A full array of in-house and clinical testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems. Bench testing included evaluation of interferences, Dynamic range and linearity, hematocrit effects, altitude effects, control solution functionality, and analytical precision. Clinical testing included evaluation of accuracy for finger stick and palm test sites for GLUCOCARD® Vital™.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Labeling, bench testing results and clinical testing results support the Indications for Use and the claim of substantial equivalence to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ferrara Meter (K063068)
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
1091152
・
510(k) Summary
:
| Submitter: | ARKRAY Factory USA, Inc.
5182 W. 76th Street
Minneapolis, MN 55439 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hamid Idrissi
Regulatory Affairs Project Manager
ARKRAY Factory USA, Inc.
5182 W. 76th Street
Minneapolis, MN 55439
Phone: 952-646-3171
Fax: 952-646-3110
idrissih@ARKRAYusa.com |
| Date Prepared: | October 19, 2009 |
| Trade Name: | GLUCOCARD® Vital™ Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345 and 862.1660; Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | Ferrara Meter (K063068) |
| Device Description: | The GLUCOCARD® Vital™ Blood Glucose Monitoring System consist
of a meter, test strips, and control solution for use as an aid to monitor
the effectiveness of diabetes control. |
| Intended Use: | The GLUCOCARD® Vital™ Blood Glucose Monitoring System is
intended for the quantitative measurement of glucose in fresh capillary
whole blood samples drawn from the fingertips and palms. Testing is
done outside the body ( In Vitro diagnostic use). It is indicated for use
at home (over the counter [OTC]) by persons with diabetes, or in
clinical settings by healthcare professionals, as an aid to monitor the
effectiveness of diabetes control.
The GLUCOCARD® Vital™ Blood Glucose Monitoring System is not
intended for the diagnosis of or screening for diabetes mellitus, and is
not intended for use on neonates. |
| Functional and
Safety Testing: | A full array of in-house and clinical testing was done consistent with
relevant FDA guidance's for blood glucose monitoring systems.
Bench testing included evaluation of interferences, Dynamic range and
linearity, hematocrit effects, altitude effects, control solution
functionality, and analytical precision.
Clinical testing included evaluation of accuracy for finger stick and
palm test sites for GLUCOCARD® Vital™. |
| Conclusion: | Labeling, bench testing results and clinical testing results support the
Indications for Use and the claim of substantial equivalence to the
predicate. |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HUMAN SERVICES - (USA)" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Arkray Factory USA, Inc. c/o Mr. Hamid Idrissi Regulatory Affairs Project Manager 5182 W. 76th Street Minneapolis. MN 55439
OCT 2 3 2009
K091102 Re:
Trade Name: Glucocard® Vital™ Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: September 09, 2009 Received: September 10, 2009
Dear Mr. Idrissi:
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); 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).
2
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement (GLUCOCARD® Vital™) r
510/k) Number (if known):
Device Name: GLUCOCARD® Vital™ Blood Glucose Monitoring System
Indications For Use:
GLUCOCARD® Vital™ Blood Glucose Monitoring System:
The GLUCOCARD® Vital™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The GLUCOCARD® Vital™ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
GLUCOCARD® Vital™ Blood Glucose Meter:
The GLUCOCARD® Vital™ Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
GLUCOCARD® Vital™ Blood Glucose Test Strips:
GLUCOCARD® Vital™ test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms when used with the GLUCOCARD® Vital™ Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter (OTC)) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure Dose CONTROL:
For use with GLUCOCARD® Vital™ Blood Glucose Meter and GLUCOCARD® Vital™ Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Level 1 (Normal) and Level 2 (High),
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use × AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
surrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Diffision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)