(231 days)
Not Found
Not Found
No
The description focuses on standard blood glucose monitoring technology and performance studies, with no mention of AI or ML.
No
The device is used to monitor blood glucose levels, which aids in managing diabetes, but it does not directly treat the condition.
Yes
Explanation: The device is explicitly stated as an "aid to monitor the effectiveness of diabetes control," which falls under the definition of a diagnostic device. It quantifies glucose as a measure of a physiological state.
No
The device description explicitly states that the system consists of a "meter, sensor test strips, and control solutions," which are hardware components, in addition to any potential software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)."
- Nature of the Test: The device measures glucose in blood samples, which is a test performed on a biological sample outside of the living body. This is the definition of an in vitro diagnostic test.
- Purpose: The purpose is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, upper arm or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
persons with diabetes (at home [over the counter [OTC]]) or healthcare professionals (in clinical settings)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing included evaluation of interferences, linearity, linear range, altitude effects, control solution functionality, and analytical precision.
Clinical testing included evaluation of accuracy for both finger stick and Alternate Site Testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A full array of in-house and clinical testing was done consistent with relevant FDA guidances for blood glucose monitoring systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Advance Micro-draw BGM
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K06377/
AUG - 9 2007
5 510(k) Summary
| Submitter: | ARKRAY Factory USA |
|---|---|
| Contact Person: | Tom Speikers |
| Director, Quality Systems and Regulatory Affairs | |
| ARKRAY Factory USA, Inc. | |
| 5182 W. 76th Street | |
| Minneapolis, MN 55439 | |
| Phone: 952-646-3168 | |
| Fax: 952-646-3110 | |
| speikerst@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 |
| Device | |
| Description: | 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. | |
| Intended Use: | 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. | |
| Functional and | |
| Safety Testing: | A full array of in-house and clinical testing was done consistent |
| with relevant FDA guidances for blood glucose monitoring | |
| systems. |
Bench testing included evaluation of interferences, linearity,
linear range, altitude effects, control solution functionality, and
analytical precision.
Clinical testing included evaluation of accuracy for both finger
stick and Alternate Site Testing.
Safety testing included evaluation of EMC. |
| Conclusion: | Labeling, bench testing results and clinical testing results support
the Indications for Use and the claim of substantial equivalence
to 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