(39 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic (IVD) intended to monitor the effectiveness of diabetes control, not to treat or prevent a disease.
No
The document explicitly states that the device "is not intended for the diagnosis of or screening for diabetes mellitus".
No
The device description explicitly states that the system consists of a meter, test strips, and control solution, which are hardware components.
Yes, the device is an IVD (In Vitro Diagnostic).
The text explicitly states:
- "Testing is done outside the body (In Vitro diagnostic use)."
- "The GLUCOCARD 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples..."
- "The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01-mini Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples..."
- "The ReliOn Micro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples..."
- "The ReliOn Micro Plus Blood Glucose Test Strips are intended to be used with the ReliOn Micro Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples..."
These statements clearly indicate that the device is used to perform diagnostic testing on samples taken from the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GLUCOCARD 01-mini 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-mini Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
For over the counter use only
The ReliOn Micro 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 other individuals The ReliOn Micro Plus Blood Glucose Test Strips are intended to be used with the ReliOn Micro Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
For over the counter use only
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW
Device Description
The GLUCOCARD 01-mini Blood Glucose Monitoring System and ReliOn Micro 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 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 done 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.
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): 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.
GLUCOCARD 01-mini Blood Glucose Monitoring System (K082417)
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.
Not Found
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).
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 - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
ARKRAY USA LONNA DENDOOVEN REGULATORY AFFAIRS SPECIALIST 5198 W. 76TH ST EDINA, MN 55439
Re: K142035
Trade/Device Name: GLUCOCARD 01-mini Blood Glucose Monitoring System. ReliOn Micro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW Dated: July 24, 2014 Received: July 28, 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 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney
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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Indications for Use
510(k) Number (if known) K142035
Device Name
The GLUCOCARD 01-mini Blood Glucose Monitoring System The ReliOn Micro Blood Glucose Monitoring System
Indications for Use (Describe)
The GLUCOCARD 01-mini 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-mini Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
The ReliOn Micro 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 Micro Plus Blood Glucose Test Strips are intended to be used with the ReliOn Micro 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)
2 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)
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510(k) Summary
| 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: | July 17, 2014 |
| Trade Name: | GLUCOCARD 01-mini Blood Glucose Monitoring System |
| ReliOn Micro Blood Glucose Monitoring System | |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| Product Codes: | CGA, NBW |
| Predicate Device: | GLUCOCARD 01-mini Blood Glucose Monitoring System (K082417) |
| Device Description: | The GLUCOCARD 01-mini Blood Glucose Monitoring System and |
| ReliOn Micro 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-mini 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-mini Blood Glucose Meter for | |
| the quantitative measurement of glucose in fresh capillary whole blood | |
| samples drawn from the fingertips, or palm. | |
| For over the counter use only | |
| The ReliOn Micro 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 | |
| other individuals | |
| The ReliOn Micro Plus Blood Glucose Test Strips are intended to be used | |
| with the ReliOn Micro Blood Glucose Meter for the quantitative measurement | |
| of glucose in fresh capillary whole blood samples drawn from the fingertips, | |
| or palm. | |
| For over the counter use only | |
| Substantial | |
| Equivalence Basis: | The new GLUCOCARD 01-mini Blood Glucose Monitoring System is |
| identical to the GLUCOCARD 01-mini (K082417, cleared by FDA | |
| October 21, 2008) except that the manufacturing process for the | |
| GLUCOCARD 01 SENSOR Blood Glucose Test Strip has been | |
| modified to allow for more efficient production (new trade name: | |
| GLUCOCARD 01 SENSOR PLUS). 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 done 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. |
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