(231 days)
The GLUCOCARD X-METER Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm 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.
The GLUCOCARD X-METER 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 provided text describes the GLUCOCARD X-METER Blood Glucose Monitoring System. However, it does not contain the specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment that would be needed to fully answer your request.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "Functional and Safety Testing" including "clinical testing included evaluation of accuracy for both finger stick and Alternate Site Testing." However, it does not provide the specific acceptance criteria (e.g., ISO 15197 compliance, specific accuracy percentages at different glucose ranges) nor the actual reported device performance metrics (e.g., bias, precision, percentage of readings within a certain range of a reference method).
2. Sample Size Used for the Test Set and Data Provenance:
The document states "clinical testing included evaluation of accuracy." However, it does not specify the sample size (number of patients or readings) used for the test set, nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data collection).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document mentions "clinical settings by healthcare professionals" as an intended use but does not provide information on how many experts were used to establish the ground truth for the test set, nor their specific qualifications. For glucose meters, the "ground truth" (reference method) is typically a laboratory-based analyzer, not expert consensus on the reading itself.
4. Adjudication Method for the Test Set:
Given that the ground truth for glucose meters is typically a laboratory reference method, an adjudication method for the test set (e.g., 2+1, 3+1) is not applicable in the same way it would be for image-based diagnostic devices. The device reading is compared directly to the reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to a blood glucose meter. This type of study is relevant for diagnostic devices that involve human interpretation of images or other complex data. Blood glucose meters provide a direct numerical output.
6. Standalone Performance Study:
Yes, a standalone performance study was implicitly done. The "clinical testing included evaluation of accuracy" refers to the device's performance in measuring glucose levels. This is a standalone evaluation of the algorithm and device without a human-in-the-loop scenario. The output is a direct glucose reading from the device.
7. Type of Ground Truth Used:
The type of ground truth used would almost certainly be a laboratory reference method (e.g., a YSI STAT PLUS Glucose & L-Lactate Analyzer or similar) for measuring glucose in blood samples. This is standard practice for blood glucose meter accuracy studies. The document does not explicitly state this, but it is the industry standard for this type of device.
8. Sample Size for the Training Set:
The document does not provide any information about a training set size. For a device like a blood glucose meter, the "training set" might refer to the data used during the development and calibration of the electrochemical sensor and algorithm. This information is typically proprietary and not included in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
Similar to the training set size, the document does not provide information on how the ground truth for the training set was established. This would relate to the methods used during the device's development and calibration, likely involving comparisons to laboratory reference methods with known concentrations.
In summary, while the document confirms clinical testing for accuracy was performed, it lacks the detailed quantitative information on acceptance criteria, specific performance metrics, sample sizes, and the exact nature of the ground truth required to fully answer your request. This level of detail is often found in the full 510(k) submission and supporting study reports, which are more extensive than the summary provided.
{0}------------------------------------------------
K06377/
AUG - 9 2007
5 510(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: | December 11, 2006 |
| Trade Name: | GLUCOCARD X-METER 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 |
| DeviceDescription: | The GLUCOCARD X-METER Blood Glucose Monitoring Systemconsists of a meter, sensor test strips, and control solutions foruse as an aid to monitor the effectiveness of diabetes control. |
| Intended Use: | The GLUCOCARD X-METER Blood Glucose Monitoring Systemis intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips,forearm, upper arm or palm. Testing is done outside the body(In Vitro diagnostic use). It is indicated for use at home (over thecounter [OTC]) by persons with diabetes, or in clinical settings byhealthcare professionals, as an aid to monitor the effectivenessof diabetes control. |
| Functional andSafety Testing: | A full array of in-house and clinical testing was done consistentwith relevant FDA guidances for blood glucose monitoringsystems.Bench testing included evaluation of interferences, linearity,linear range, altitude effects, control solution functionality, andanalytical precision.Clinical testing included evaluation of accuracy for both fingerstick and Alternate Site Testing.Safety testing included evaluation of EMC. |
| Conclusion: | Labeling, bench testing results and clinical testing results supportthe Indications for Use and the claim of substantial equivalenceto the predicate. |
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
AUG - 9 2007
Arkray Factory USA, Inc. c/o Mr. Tom Speikers Director, Quality Systems & Regulatory Affairs 5182 W. 76th Street Minneapolis, MN 55439
Re: K063771
Trade Name: GlucocardX-Meter Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: July 06, 2007 Received: July 10, 2007
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).
{2}------------------------------------------------
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.
Yéan 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
{3}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K063771
Device Name: GLUCOCARD X-METER Blood Glucose Monitoring System
Indications For Use:
GLUCOCARD X-METER Blood Glucose Monitoring System:
The GLUCOCARD X-METER Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm 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 X-METER:
The GLUCOCARD X-METER is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm or palm. GLUCOCARD X-SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD X-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 X-SENSOR Blood Glucose Test Strips:
GLUCOCARD X-SENSOR Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm or paim. GLUCOCARD X-SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD X-METER 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.
GLUCOCARD X-METER CONTROL:
For use with GLUCOCARD X-METER Blood Glucose Meter and GIJUCOCARD X-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 (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)
Carol C. Benam
Division Sign-Off
Evaluation and Sa
§ 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.