(27 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 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.
For over the counter use only
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.
For over the counter use only
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 provided FDA 510(k) summary (K142336) describes the GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System. This submission focuses on modifications to certain exterior materials used in the manufacture of the meter. Therefore, the primary studies mentioned are related to demonstrating the continued safety and performance of the device despite these material changes, rather than a clinical effectiveness study of the glucose monitoring itself.
Based on the provided document, here's an analysis of the acceptance criteria and supporting studies related to the modifications:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Material Modifications Safety | Viral elimination effectiveness | Studies were conducted on the surfaces of the GLUCOCARD 01 and ReliOn Confirm Meters. (Specific results not detailed in this summary, but the conclusion states substantial equivalence.) |
| Cleaning and Disinfection Durability | Withstand multiple cleaning and disinfection cycles | Testing was performed to demonstrate that the GLUCOCARD 01 and ReliOn Confirm meters can withstand multiple cleaning and disinfection cycles. (Specific results not detailed in this summary, but the conclusion states substantial equivalence.) |
| Physical Durability | Robustness of meter case design (e.g., drop, button durability) | Drop testing and button durability studies demonstrate that the material changes do not affect the robustness of the meter case design. (Specific results not detailed in this summary, but the conclusion states substantial equivalence.) |
2. Sample Size and Data Provenance for Test Set
The document does not specify sample sizes for the viral elimination, cleaning/disinfection, or drop/button durability test sets. It also does not explicitly state the provenance (e.g., country of origin) of the data for these engineering/material tests. These are typically simulated or laboratory tests rather than patient data.
3. Number of Experts to Establish Ground Truth and Qualifications
This information is not provided in the document. For engineering/material tests, "ground truth" would typically be established by established test methodologies and internal validation, rather than expert consensus in the clinical sense.
4. Adjudication Method
This information is not provided as it is not relevant for the type of engineering/material testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. This type of study is more relevant for AI/radiology devices where human interpretation is a key component. The device described is a glucose meter, and the submitted changes are material-related.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study of an algorithm was conducted or described in this summary. The device's primary function is a measurement system; the "performance" here refers to the physical and safety aspects after material changes.
7. Type of Ground Truth Used
For the safety and durability tests:
- Viral elimination effectiveness: The ground truth would be established by predefined microbiological assay standards and protocols to determine the reduction of viral load on surfaces.
- Cleaning and disinfection durability: The ground truth would be resistance to degradation or damage after exposure to specified cleaning agents and cycles, measured against physical and functional integrity criteria.
- Physical durability (drop/button): The ground truth would be the device's ability to remain functional and intact after specified mechanical stresses, measured against established engineering and performance specifications.
8. Sample Size for the Training Set
No training set is mentioned in the context of these material modification studies. This typically refers to machine learning models, which are not described here.
9. How Ground Truth for Training Set Was Established
Not applicable, as no training set was identified.
Summary of the K142336 Submission Context:
It's important to note that this 510(k) submission (K142336) is for modifications to an already cleared predicate device (K124021). The "Reason for Submission" explicitly states "Modifications to certain exterior materials used in the manufacture of the meter." This means the core functionality and clinical accuracy of the glucose measurement system were likely established in the predicate submission. The studies presented here are specifically to demonstrate that the new materials do not adversely affect the device's safety (e.g., viral transmission risk, ability to be disinfected) or durability, thereby maintaining substantial equivalence to the predicate.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a cascading manner. The profiles are connected by a flowing, ribbon-like element. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2014
ARKRAY FACTORY INC. LONNA M. DENDOOVEN REGULATORY AFFAIRS SPECIALIST 5182 WEST 76TH STREET EDINA MN 55439
Re: K142336
Trade/Device Name: GLUCOCARD 01 Blood Glucose Monitoring System ReliOn Confirm Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: August 20, 2014 Received: August 21, 2014
Dear Ms. 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.
{1}------------------------------------------------
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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K142336
Device Name
The 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K142336
Device Name
The 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{4}------------------------------------------------
6 510(k) Summary
| Submitter: | ARKRAY Factory, Inc. |
|---|---|
| 1480 Koji, Konan-cho | |
| Koka-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) 646-3230dendoovenl@arkrayusa.com |
| Date Prepared: | August 20, 2014 |
| 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 and ReliOnConfirm Blood Glucose Monitoring System (K124021) |
| 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 by persons with diabetes as an aid to monitor the effectiveness ofdiabetes control. It is not intended for the diagnosis of or screening fordiabetes mellitus, and is not intended for use on neonates. It is intendedfor single patient use and should not be shared with other individuals. |
| The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips areintended to be used with the GLUCOCARD 01 Blood Glucose Meterfor the quantitative measurement of glucose in fresh capillary wholeblood samples drawn from the fingertips, or palm. | |
| For over the counter use only | |
| 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 bypersons with diabetes as an aid to monitor the effectiveness of diabetes |
{5}------------------------------------------------
| control. It is not intended for the diagnosis of or screening for diabetesmellitus, and is not intended for use on neonates. It is intended forsingle patient use and should not be shared with other individuals. | |
|---|---|
| The ReliOn Confirm Plus Blood Glucose Test Strips are intended to beused with the ReliOn Confirm Blood Glucose Meter for thequantitative measurement of glucose in fresh capillary whole bloodsamples drawn from the fingertips, or palm. | |
| For over the counter use only | |
| Reason forSubmission | Modifications to certain exterior materials used in the manufacture ofthe meter |
| Functional andSafety Testing: | Viral elimination effectiveness studies were conducted on the surfacesof the GLUCOCARD 01 and ReliOn Confirm Meters |
| Cleaning and disinfection durability testing was performed todemonstrate that the GLUCOCARD 01 and ReliOn Confirm meterscan withstand multiple cleaning and disinfection cycles. | |
| Drop testing and button durability studies demonstrate that the materialchanges do not affect the robustness of the meter case design. | |
| Conclusion: | The modified GLUCOCARD 01 and ReliOn Confirm Blood GlucoseMonitoring Systems are substantially equivalent to the predicateGLUCOCARD 01 and ReliOn Confirm Blood Glucose Monitoring |
§ 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.