(60 days)
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 (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-mini consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control.
The provided text describes the ARKRAY GLUCOCARD™ 01-mini Blood Glucose Monitoring System and mentions a clinical study to evaluate system accuracy. However, it does not provide specific acceptance criteria or detailed results of that study, nor does it include information about sample sizes, ground truth establishment, or expert involvement in the way an AI/ML device study would.
Therefore, many of the requested fields cannot be filled directly from the provided text. I will indicate where information is missing.
Here's a breakdown based on the provided text, with missing information noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (From "Functional and Safety Testing" section) |
|---|---|
| Specific accuracy metrics (e.g., % within ±X mg/dL of reference, ISO 15197 compliance, etc.) are not provided. | A clinical study was done with persons with diabetes to evaluate system accuracy. |
| Analytical verification testing was performed to evaluate precision, dynamic range, and linearity. |
2. Sample size used for the test set and data provenance
- Sample Size (Test Set): Not specified in the provided text. The text only mentions "A clinical study was done with persons with diabetes."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "persons with diabetes." Given the submitter's location (Minneapolis, MN, USA), it's highly likely the study was conducted in the USA, but this is an inference, not stated fact. The study was retrospective.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Number of Experts: Not applicable/Not specified. For a blood glucose monitoring system, the "ground truth" is typically established by a laboratory reference method, not by expert consensus on images or interpretations.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified. This concept (e.g., 2+1, 3+1) is relevant for studies involving human readers and interpretations (like radiology), not for direct measurement devices where a reference standard provides the "truth."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is a blood glucose monitoring system, not an AI/ML diagnostic tool meant to assist human readers in interpreting complex data.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The "system accuracy" evaluated in the clinical study likely refers to the standalone performance of the device (meter + test strips) against a laboratory reference method. The text states: "A clinical study was done... to evaluate system accuracy." Analytical verification also covered precision, dynamic range, and linearity, which relate to standalone performance characteristics.
7. The type of ground truth used
- Type of Ground Truth: For blood glucose monitors, the ground truth is typically a laboratory reference method (e.g., a YSI Analyzer or equivalent) that is highly accurate and precise, performed on the same blood samples as the device under test. The document does not explicitly name the reference method but implies one was used to determine "system accuracy."
8. The sample size for the training set
- Training Set Sample Size: Not applicable/Not specified. This device is not described as involving machine learning or AI that would require a distinct "training set" in the conventional sense. The "Functional and Safety Testing" likely refers to validation cohorts.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable. Since there's no mention of a training set for an AI/ML algorithm, this question is not relevant to the provided text.
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OCT 2 1 2008
| Submitter: | ARKRAY Factory USA, IncEst. Number: 1832816Owner/Operator Number: 8030316 |
|---|---|
| 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: | August 20, 2008 |
| Trade Name: | GLUCOCARD™ 01-mini Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System |
| Device Description: | GLUCOCARD™ 01-mini consists of a meter, test strips, and control solutions for use in measuring blood glucose 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 (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. |
| 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 and linearity. |
| Conclusion: | The modified GLUCOCARD™ 01-mini Blood Glucose Monitoring System is substantially equivalent to the predicate GLUCOCARD™ 01 Blood Glucose Monitoring System. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with a simple, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
ARKRAY Factory USA, Inc. c/o Tom Speikers Director, Quality Systems and Regulatory Affairs 5182 W. 76th Street Minneapolis, MN 55439
OCT 2 1 2008
K082417 Re:
Trade/Device Name: GLUCOCARD™ 01-mini Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: September 18, 2008 Received: September 22, 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 frea mober (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Sean 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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5 Indications for Use Statement
510(k) Number (if known):
): K082917
Device Name: ARKRAY GLUCOCARD™ 01-mini Blood Glucose Monitoring System
Indication For Use:
GLUCOCARD™ 01-mini Blood Glucose Monitoring System:
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 (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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use × AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082417
CONFIDENTIAL
§ 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.