(197 days)
Not Found
No
The description mentions an "algorithm programmed in the GlucoDr™ Plus test meter" to convert electrical currents to glucose concentration, but there is no mention of AI, ML, or any learning capabilities. The mechanism described is a standard electrochemical measurement with a fixed conversion algorithm.
No.
The device is intended for in vitro diagnostic use to measure glucose levels, aiding in monitoring diabetes control. It does not directly treat or cure a disease or condition.
Yes
The text explicitly states, "The GlucoDr™ Plus system is intended for in vitro diagnostic use." This indicates its purpose is to aid in diagnosis by measuring glucose levels.
No
The device description explicitly states the system consists of a test meter, test strips, and control solution, which are all hardware components. While there is an algorithm programmed into the meter, the system is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The GlucoDr™ Plus system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The GlucoDr™ Plus system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood. Testing sites include traditional fingertip site along with palm, arm and thigh.
The GlucoDr "1" Plus system may be used by healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home as aid in monitoring the effectiveness of diabetes control program.
The GlucoDr The Plus system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The GlucoDr™ Plus control solution is for use with the The GlucoDr™ Plus meters and strips as a quality control check to verify the accuracy of blood glucose test results.
Product codes
LFR, NBW, JJX
Device Description
The GlucoDr™ Plus system consists of GlucoDr™ Plus Test Meter, GlucoDr™ Plus Test strips and GlucoDr™ Plus control solution.
The GlucoDr™ Plus system is based on measurement of electrical currents caused by the reaction of glucose with reagents on the gold electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents are proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ Plus test meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Traditional fingertip site along with palm, arm and thigh (for blood sampling)
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
B y healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
medical instruments / medical informatics
510(k) Summary
According to the requirements of 21 CFR.807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1. Submitter | All Medicus., Co. Ltd. | |
|---|---|---|
| Name, | #7608, Dong-il Techno Town 7th, | FEB 27 2009 |
| Address, | 823, Gwanyang 2-dong, Dongan-gu, Anyang. | |
| Contact | Gyeonggi-do, 431-062, Korca | |
| Phone : (82) 31-425-8288 | ||
| Fax : (82) 31-422-8589 | ||
| Contact Person : Ms. Margaret Kim |
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Date Prepared May, 2008
-
Device Name
Propriety name : GlucoDr™ Plus System Common name : Blood glucose monitoring system Classification name : Glucose Test System Class II
(21 CFR Section 862.1345, Product Code : LFR, NBW) Quality control material Class I
(21 CFR Section 862.1660, Product Code : JJX)
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Predicate We claim substantial equivalence to the Roche Diagnostics Device Corporation, Accu-Chek Aviva System. (K043474)
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Device The GlucoDr™ Plus system consists of GlucoDr™ Plus Test Meter, GlucoDr™ Description Plus Test strips and GlucoDr™ Plus control solution.
The GlucoDr™ Plus system is based on measurement of electrical currents caused by the reaction of glucose with reagents on the gold electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents are proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ Plus test meter.
1
medical instruments / medical informatics
The GlucoDr™ Plus system is intended for in vitro diagnostic use (i.e., for 6. Intended use external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood. Testing sites include traditional fingertip site along with palm, arm and thigh.
The GlucoDr™ Plus system may be used by healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home as aid in monitoring the effectiveness of diabetes control program.
The GlucoDr™ Plus system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The GlucoDr™ Plus control solution is for use with the The GlucoDr™ Plus meters and strips as a quality control check to verify the accuracy of blood glucose test results.
The GlucoDr"™ Plus system has equivalcnt technological characteristics as the 7. Comparison to Accu-Chek Aviva System. The GlucoDr™ Plus system also has the same Predicate Device intended use as the Accu-Chek Aviva System.
- Conclusion
The GlucoDr™ Plus system is substantially equivalent to the predicate device system.
Total 2 pages
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
All Medicus Co., Ltd. c/o Ms. Margaret Kim Regional Manager No. 7608 Dong-il Techno Town 7TH 823 Gwanyang 2-dong, Dongan-gu Anyang, Gyeonggi-do Republic of Korea 431-062
-EB 2 7 2009
Re: . K082328
Trade/Device Name: GlucoDr™ Plus System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR and JJX Dated: January 16, 2009 Received: January 16, 2009
Dear Ms. Kim:
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).
3
Page - 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 I logal] 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 (301) 594-3084. 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 tolloffree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
Indication for Use
510(k) Number (if known): K082328
Device Name: GlucoDr™ Plus System
Indication For Use:
The GlucoDr™ Plus system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood. Testing sites include traditional fingertip site along with palm, arm and thigh.
The GlucoDr "1" Plus system may be used by healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home as aid in monitoring the effectiveness of diabetes control program.
The GlucoDr The Plus system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The GlucoDr™ Plus control solution is for use with the The GlucoDr™ Plus meters and strips as a quality control check to verify the accuracy of blood glucose test results.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use V. (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 A Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082358