(550 days)
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating or providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" states that it is for "quantitative measurement of glucose" and "aid to monitor the effectiveness of diabetes control," which are diagnostic purposes for managing a medical condition, even though it explicitly excludes diagnosis or screening for diabetes mellitus itself. It falls under the umbrella of "In Vitro diagnostic use."
No
The device description explicitly states that the system consists of a meter, test strips, and control solution, which are hardware components.
Yes, the text explicitly states that this device 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 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. 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 as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. 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 as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The GLUCOCARD 01 SENSOR Plus Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
The ReliOn Confirm Plus Blood Glucose Test Strips are intended to be used with the ReliOn Confirm Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
Product codes
CGA, NBW
Device Description
The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm 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, or palm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
Use at home (over the counter [OTC]) by persons with diabetes.
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)
A clinical study was conducted with persons with diabetes to evaluate system accuracy and to assess ease of use.
Analytical verification testing was performed to evaluate precision, dynamic range/linearity, interfering substances, sample volume, stability and the effect of altitude, hematocrit, and environmental conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GLUCOCARD 01 Blood Glucose Monitoring System (K073416)
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
5 510(k) Summary
JUN 3 0 2014
| Submitter: | ARKRAY Factory, Inc.
1480 Koji, Konan-cho
Koka-shi, Shiga, JAPAN, 520-3306 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lonna M. DenDooven
Regulatory Affairs Specialist
ARKRAY Factory USA, Inc.
5182 West 76th Street
Edina, Minnesota, USA 55439
Phone: (952) 646-3175
Fax: (952) 646-3230 |
| Date Prepared: | June 30, 2013 |
| Trade Name: | GLUCOCARD 01 Blood Glucose Monitoring System
ReliOn Confirm Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| Product Codes: | CGA, NBW |
| Predicate Device: | GLUCOCARD 01 Blood Glucose Monitoring System (K073416) |
| Device Description: | The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn
Confirm 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 01 Blood Glucose Monitoring System is intended
for the quantitative measurement of glucose in fresh capillary whole
blood samples drawn from the fingertips, or palm. 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 as an aid to
monitor the effectiveness of diabetes control. It is not intended for the
diagnosis of or screening for diabetes mellitus, and is not intended for
use on neonates. It is intended for single patient use and should not be
shared with other individuals.
The ReliOn Confirm Blood Glucose Monitoring System is intended for
the quantitative measurement of glucose in fresh capillary whole blood
samples drawn from the fingertips, or palm. 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 as an aid to monitor the
effectiveness of diabetes control. It is not intended for the diagnosis of
or screening for diabetes mellitus, and is not intended for use on
neonates. It is intended for single patient use and should not be shared
with other individuals. |
1
| Substantial
Equivalence Basis: | The new GLUCOCARD 01 Blood Glucose Monitoring System is
identical to the GLUCOCARD 01 (K073416, cleared by FDA June 13,
2008) except that the manufacturing process for the GLUCOCARD 01
SENSOR Blood Glucose Test Strip has been modified to allow for
more efficient production. The fundamental scientific technology of the
modified test strip has not changed. The modifications to the test strip
did not require any changes to meter hardware, software or other
components of the test system. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and
Safety Testing: | A clinical study was conducted with persons with diabetes to evaluate
system accuracy and to assess ease of use.
Analytical verification testing was performed to evaluate precision,
dynamic range/linearity, interfering substances, sample volume,
stability and the effect of altitude, hematocrit, and environmental
conditions. |
| Conclusion: | Labeling, bench testing results and clinical testing results support the
Indications for Use and the claim of substantial equivalence to the
predicate. |
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ARKRAY FACTORY INC. LONNA DENDOOVEN REGULATORY AFFAIRS SPECIALIST 2198 WEST 76TH ST EDINA MN 55439
June 30, 2014
Re: K124021
Trade/Device Name: ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System ReliOn Confirm Blood Glucose Monitoring
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW.CGA Dated: June 18. 2014 Received: June 19, 2014
Dear Ms. Lonna Dendooven:
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 reclassilied 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. Ilsuing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. 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 complics 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2-Ms. Dendooven
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) k 12402 1
Device Name
GLUCOCARD 01 Blood Glucose Monitoring System
Indications for Use (Describe)
The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The GLUCOCARD 01 SENSOR Plus Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
:
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stayce Beck -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) k 124021
Device Name
ReliOn Confirm Blood Glucose Monitoring System
Indications for Use (Describe)
The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The ReliOn Confirm Plus Blood Glucose Test Strips are intended to be used with the ReliOn Confirm Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stayce Beck -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
. , ,