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.

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.

AI/ML Overview

This document describes the 510(k) premarket notification for the GLUCOCARD 01-mini Blood Glucose Monitoring System and the ReliOn Micro Blood Glucose Monitoring System, which are intended for quantitative measurement of glucose in fresh capillary whole blood samples.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state the quantitative acceptance criteria for system accuracy in a table format, nor does it provide detailed numerical results of the device's performance against such criteria. It generally states that a "clinical study was done with persons with diabetes to evaluate system accuracy."

However, glucose monitoring systems like this are typically evaluated against standards like ISO 15197 for accuracy. A common acceptance criterion for blood glucose meters, as per ISO 15197, often includes:

95% of results falling within ±15 mg/dL of the reference method for glucose concentrations < 100 mg/dL.
95% of results falling within ±15% of the reference method for glucose concentrations ≥ 100 mg/dL.

Without the full study report, specific reported performance values against these criteria are not available in this document.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions "A clinical study was done with persons with diabetes to evaluate system accuracy and to assess ease of use." However, it does not specify the sample size for this clinical study.
Data Provenance: The document states that the clinical study was conducted with "persons with diabetes," implying real-world data collection. It doesn't specify the country of origin, but the submitting company is ARKRAY Factory, Inc. from Japan, with a US contact. It also doesn't explicitly state if the study was retrospective or prospective, but clinical studies for device accuracy are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts or their qualifications used to establish the ground truth for the test set. For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., an automated analyzer calibrated to a recognized standard) rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

As the ground truth is established by a laboratory reference instrument, there isn't typically an "adjudication method" in the sense of expert review or consensus for the test set results directly. The device's readings are compared against the reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for medical imaging or diagnostic interpretation tasks where human readers evaluate cases, often with and without AI assistance, to measure the impact of the AI on reader performance. For a blood glucose monitoring system, the device directly outputs a quantitative measurement, and human "readers" are not involved in interpreting the results in a diagnostic imaging sense.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the system accuracy evaluation is inherently a standalone performance study. The GLUCOCARD 01-mini and ReliOn Micro Blood Glucose Monitoring Systems are intended to provide a quantitative glucose measurement directly. The clinical study mentioned evaluates the system's ability to accurately measure glucose without human interpretation influencing the measurement itself. The "human-in-the-loop" aspect for a blood glucose meter primarily involves the user performing the test correctly and interpreting their own results, not in aiding the device's measurement.

7. Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method that is highly accurate and traceable to an international standard. While not explicitly stated in this summary, it is standard practice for glucose meter validation to compare the device's readings against a clinical laboratory analyzer.

8. Sample Size for the Training Set

The document does not provide any information about a "training set." This device is a blood glucose meter, not an AI/machine learning algorithm that requires a training set in the typical sense for image recognition or predictive modeling. The device's performance is determined by its electrochemical measurement technology, calibration, and manufacturing consistently.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of an AI/machine learning model for this medical device, there is no ground truth established for a training set. The device itself is calibrated during manufacturing to known glucose concentrations using reference methods.

Summary

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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)

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 thequantitative measurement of glucose in fresh capillary whole blood samplesdrawn from the fingertips, or palm. Testing is done outside the body (In Vitrodiagnostic use). It is indicated for use at home by persons with diabetes as anaid to monitor the effectiveness of diabetes control. It is not intended for thediagnosis 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 usedwith the ReliOn Micro Blood Glucose Meter for the quantitative measurementof glucose in fresh capillary whole blood samples drawn from the fingertips,or palm.For over the counter use only
SubstantialEquivalence Basis:	The new GLUCOCARD 01-mini Blood Glucose Monitoring System is
	identical to the GLUCOCARD 01-mini (K082417, cleared by FDAOctober 21, 2008) except that the manufacturing process for theGLUCOCARD 01 SENSOR Blood Glucose Test Strip has beenmodified to allow for more efficient production (new trade name:GLUCOCARD 01 SENSOR PLUS). The fundamental scientifictechnology of the modified test strip has not changed. Themodifications to the test strip did not require any changes to meterhardware, software or other components of the test system.
Functional andSafety 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 environmentalconditions.
Conclusion:	Labeling, bench testing results and clinical testing results support the
	Indications for Use and the claim of substantial equivalence to thepredicate.

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Regulation Number and Section

§ 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.