(550 days)
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 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.
The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System did not include AI, therefore much of this information is not applicable.
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria (e.g., specific percentages for accuracy within certain glucose ranges) or detailed performance statistics were provided in the document beyond a general statement of positive clinical study results.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "A clinical study was conducted with persons with diabetes to evaluate system accuracy and to assess ease of use." However, the sample size for this clinical study and the data provenance (country of origin, retrospective or prospective nature) are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as this device measures glucose and does not typically involve expert interpretation as a ground truth method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this device measures glucose and does not involve human readers interpreting cases or AI assistance in that context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a standalone blood glucose monitoring system. Its "performance" refers to the accuracy of its glucose measurements. The clinical study evaluated "system accuracy," which inherently means the performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood glucose monitoring systems, the ground truth for accuracy studies is typically established by comparing the device's readings to a laboratory reference method (e.g., a central lab analyzer) known for its high accuracy in measuring blood glucose. The document does not explicitly state the specific ground truth method used, but it's universally implied for such devices.
8. The sample size for the training set
Not applicable, as this device does not utilize an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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5 510(k) Summary
JUN 3 0 2014
| Submitter: | ARKRAY Factory, Inc.1480 Koji, Konan-choKoka-shi, Shiga, JAPAN, 520-3306 |
|---|---|
| Contact Person: | Lonna M. DenDoovenRegulatory Affairs SpecialistARKRAY Factory USA, Inc.5182 West 76th StreetEdina, Minnesota, USA 55439Phone: (952) 646-3175Fax: (952) 646-3230 |
| Date Prepared: | June 30, 2013 |
| Trade Name: | GLUCOCARD 01 Blood Glucose Monitoring SystemReliOn 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 ReliOnConfirm Blood Glucose Monitoring System consist of a meter, teststrips, and control solution for use as an aid to monitor the effectivenessof diabetes control. |
| Intended Use: | The GLUCOCARD 01 Blood Glucose Monitoring System is intendedfor the quantitative measurement of glucose in fresh capillary wholeblood samples drawn from the fingertips, or palm. Testing is doneoutside the body (In Vitro diagnostic use). It is indicated for use athome (over the counter [OTC]) by persons with diabetes as an aid tomonitor the effectiveness of diabetes control. It is not intended for thediagnosis of or screening for diabetes mellitus, and is not intended foruse on neonates. It is intended for single patient use and should not beshared with other individuals.The ReliOn Confirm Blood Glucose Monitoring System is intended forthe quantitative measurement of glucose in fresh capillary whole bloodsamples drawn from the fingertips, or palm. Testing is done outside thebody (In Vitro diagnostic use). It is indicated for use at home (over thecounter [OTC]) by persons with diabetes as an aid to monitor theeffectiveness of diabetes control. It is not intended for the diagnosis ofor screening for diabetes mellitus, and is not intended for use onneonates. It is intended for single patient use and should not be sharedwith other individuals. |
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| SubstantialEquivalence Basis: | The new GLUCOCARD 01 Blood Glucose Monitoring System isidentical to the GLUCOCARD 01 (K073416, cleared by FDA June 13,2008) except that the manufacturing process for the GLUCOCARD 01SENSOR Blood Glucose Test Strip has been modified to allow formore efficient production. The fundamental scientific technology of themodified test strip has not changed. The modifications to the test stripdid not require any changes to meter hardware, software or othercomponents of the test system. |
|---|---|
| Functional andSafety Testing: | A clinical study was conducted with persons with diabetes to evaluatesystem 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 environmentalconditions. |
| Conclusion: | Labeling, bench testing results and clinical testing results support theIndications for Use and the claim of substantial equivalence to thepredicate. |
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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
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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.
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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."
. , ,
§ 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.