(193 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, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
GLUCOCARD™ 01 Blood Glucose Meter:
The GLUCOCARD™ 01 Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD™ 01 Blood Glucose Meter. 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, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips:
GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the palm. GLUCOCARD™ 01 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
CIECOCARD" 01 CONTROLA
For use with GLUCOCARD™ 01 Blood Glucose Meter and GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in three levels - Low (L), Normal (N) and High (H).
The GLUCOCARD 01 Blood Glucose Monitoring System consists of a meter, sensor test strips, and control solutions for use as an aid to monitor the effectiveness of diabetes control.
The ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples. The acceptance criteria and supporting study details are as follows:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a table format that compares against device performance. However, it indicates "a full array of in-house and clinical testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems." The conclusion states that "bench testing results and clinical testing results support the Indications for Use and the claim of substantial equivalence to the predicate," the Advance Micro-draw BGM.
Based on typical FDA expectations for blood glucose monitoring systems, common accuracy criteria include:
- ISO 15197:2003 (older standard applicable around 2008):
- 95% of results must be within ±15 mg/dL of the laboratory reference method for glucose concentrations < 75 mg/dL.
- 95% of results must be within ±20% of the laboratory reference method for glucose concentrations ≥ 75 mg/dL.
- Clinical Accuracy: Often assessed using Clarke Error Grid Analysis, where a high percentage of results fall within zones A and B (clinically acceptable accuracy).
Without specific numerical results or predefined criteria from the document, a direct table of acceptance vs. performance cannot be constructed. The study implies that the device met the existing FDA guidelines and demonstrated substantial equivalence to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the clinical test set used to evaluate accuracy. It only states that "Clinical testing included evaluation of accuracy for both finger stick and Alternate Site Testing."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission to the FDA, it is highly likely that the clinical studies were conducted in the USA and were prospective in nature to gather performance data for the specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the clinical test set. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) operated by trained laboratory personnel, rather than interpretation by clinical experts in the same way an imaging device might use radiologists.
4. Adjudication Method for the Test Set
Not applicable in this context. Blood glucose measurements are quantitative and compared directly to a laboratory reference standard. There is no ambiguous interpretation that would require adjudication among multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a blood glucose meter, not an AI-assisted diagnostic tool where human readers interpret results. The study focuses on the accuracy of the device's quantitative measurement against a reference standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this was a standalone study. The GLUCOCARD 01 Blood Glucose Monitoring System's performance (i.e., its accuracy in measuring glucose) was evaluated directly against a laboratory reference method. Although users operate the device and interpret the numerical output, the accuracy evaluation itself is of the device's measurement capability without an "AI assistance" component to be compared against human interpretation.
7. Type of Ground Truth Used
The ground truth used for the clinical accuracy evaluation was a laboratory reference method (e.g., a glucose analyzer like a YSI instrument), which provides a highly accurate and precise measurement of blood glucose concentration.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. Blood glucose meters typically do not involve AI algorithms that require a separate training set in the conventional sense. Their calibration and performance are based on chemical and electrochemical principles and are validated through standard bench and clinical testing.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of an AI/ML algorithm is not applicable for this type of medical device based on the information provided. The device's internal calibration and analytical performance are established through rigorous engineering, chemical formulation, and extensive bench testing (linearity, analytical precision, interference studies) using samples with known glucose concentrations, rather than a separate "training set" with established ground truth.
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JUN 1 3 2008
:
510(k) Summary
| Submitter: | ARKRAY Factory USA |
|---|---|
| Contact Person: | Tom SpeikersDirector, Quality Systems and Regulatory AffairsARKRAY Factory USA, Inc.5182 W. 76th StreetMinneapolis, MN 55439Phone: 952-646-3168Fax: 952-646-3110speikerst@ARKRAYusa.com |
| Date Prepared: | November 8, 2007 |
| Trade Name: | GLUCOCARD 01 Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | Advance Micro-draw BGM |
| Device Description: | The GLUCOCARD 01 Blood Glucose Monitoring System consists of ameter, sensor test strips, and control solutions for use as an aid tomonitor the effectiveness of 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, or in clinicalsettings by healthcare professionals, as an aid to monitor theeffectiveness of diabetes control. |
| Functional andSafety Testing: | A full array of in-house and clinical testing was done consistent withrelevant FDA guidance's for blood glucose monitoring systems.Bench testing included evaluation of interferences, linearity, linearrange, altitude effects, control solution functionality, and analyticalprecision.Clinical testing included evaluation of accuracy for both finger stick andAlternate Site Testing.Safety testing included evaluation of EMC. |
| 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/1/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 3 2008
ARKRAY Factory USA, Inc c/o Mr. Tom Speikers 5182 W. 76th Street Minneapolis, MN 55439
Re: K073416
Trade/Device Name: ARKRAY GLUCOCARD™ 01 Blood Monitoring System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: April 30, 2008 Received: May 01, 2008
Dear Mr. Speikers:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K073416
Device Name: ARKRAY GLUCOCARD™ 01 Blood Monitoring System
Indication For Use:
GLUCOCARD™ 01 Blood Glucose Monitoring System:
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, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
GLUCOCARD™ 01 Blood Glucose Meter:
The GLUCOCARD™ 01 Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD™ 01 Blood Glucose Meter. 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, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips:
GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the palm. GLUCOCARD™ 01 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
CIECOCARD" 01 CONTROLA
For use with GLUCOCARD™ 01 Blood Glucose Meter and GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in three levels - Low (L), Normal (N) and High (H).
Prescription Use (21 CFR Part 801 Subpart D) And Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073416
§ 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.