(171 days)
Not Found
No
The description mentions an "algorithm programmed in the GlucoDr™ SuperSensor test meter" to convert electrical currents to glucose concentration, but there is no mention of AI, ML, or any related concepts like training sets or performance metrics typically associated with AI/ML devices. The technology described is based on electrochemical measurement and a standard algorithm.
No
This device is an in vitro diagnostic (IVD) device used for measuring glucose levels, not for treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The GlucoDr™ SuperSensor system is intended for in vitro diagnostic use." Although it also states it's "not intended for the diagnosis of or screening for diabetes mellitus," it is used for the quantitative measurement of glucose, which is a diagnostic function relating to monitoring and managing a condition.
No
The device description explicitly states that the system consists of a test meter, test strips, and control solution, which are hardware components.
Yes, based on the provided information, the GlucoDr™ SuperSensor system is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The GlucoDr™ SuperSensor 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 from the fingertip." This is the most direct confirmation.
- Nature of the Device: The device measures glucose in blood samples, which is a classic example of an in vitro diagnostic test. It analyzes a biological sample outside of the body to provide information about a person's health status.
The other sections like "Device Description" and "Intended User / Care Setting" further support this by describing how the device works on a biological sample and who is intended to use it for diagnostic purposes (monitoring glucose levels in diabetic individuals).
N/A
Intended Use / Indications for Use
The GlucoDr™ SuperSensor 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 from the fingertip.
The GlucoDr™ SuperSensor system may be used by healthcare professionals or for self testing by diabetic lay users in the home.
The GlucoDr"M SuperSensor system is not intended for the diagnosis of or screening for diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
LFR, NBW, JJX
Device Description
The GlucoDr™ SuperSensor system consists of the GlucoDr™ SuperSensor Test Meter, GlucoDr™ SuperSensor Test strips and GlucoDr™ SuperSensor control solution.
The GlucoDr™ SuperSensor system is based on measurement of electrical currents caused by the reaction of glucose with the regents on the glod electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents is proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ SuperSensor test meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The GlucoDr™ SuperSensor system is not intended for use on neonates.
Intended User / Care Setting
healthcare professionals or for self testing by diabetic lay users in the 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): 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.
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
OCT 7 - 2005
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, | #7106, Dong-il Techno Town 7th., |
| Address, | 823, Gwanyang 2-dong, Dongan-gu, Anyang. |
| Contact | |
| Gyeonggi-do, 431-062, Korea | |
| Phone : (82) 31-425-8288 | |
| Fax : (82) 31-422-8589 | |
| Contact Person : Mr. Chang, Je Young | |
| 2. Date Prepared | Mar 07, 2005 |
| 3. Device Name | Propriety name : GlucoDr™ SuperSensor System |
| Common name : Blood glucose monitoring system | |
| Classification name : Glucose Test System | |
| (21 CFR Section 862.1345, Product Code : LFR) | |
| 4. Predicate | We claim substantial equivalence to the Roche Diagnostics |
| Device | Corporation, Accu-Chek Advantage System. (K032552) |
| 5. Device | The GlucoDr™ SuperSensor system consists of the GlucoDr™ |
| Description | SuperSensor Test Meter, GlucoDr™ SuperSensor Test strips |
| and GlucoDr™ SuperSensor control solution. | |
| The GlucoDr™ SuperSensor system is based on measurement of | |
| electrical currents caused by the reaction of glucose with the | |
| regents on the glod electrode strip. Glucose in the sample reacts | |
| with glucose dehydrogenase and mediators. This reaction creates | |
| electrical currents. The subsequent electrical currents is proportional | |
| to the glucose concentration in the blood and converted to the | |
| equivalent glucose concentration by the algorithm programmed in | |
| the GlucoDr™ SuperSensor test meter. |
1
- The GlucoDr™ SuperSensor system is intended for in vitro diagnostic 6. Intended use use (i.e., for external use only) for quantitative measurement of glucose in capillary, venous, and arterial whole blood.
-
- Comparison to The GlucoDr™ SuperSensor system has equivalent technological characteristics as the Accu-Chek Advantage System. The GlucoDr™ Predicate Device SuperSensor system also has the same intended use as the Accu-Chek Advantage System.
- The GlucoDr™ SuperSensor system is substantially equivalent to the 8. Conclusion predicate device system.
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable.
Public Health Service
OCT 7 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Je Young Chang All Medicus., Co.Ltd. 7106, Dong-il Techno Town 7th 823, Gwanyang 2-dong, Dongan-gu, Anyang Gyeonggi-do, 431-062, Korea
Re: K050985
Trade/Device Name: GlucoDr™SuperSensor Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW LFR, JJX Dated: September 30, 2005 Received: October 4, 2005
Dear Mr. Chang:
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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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 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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Carol C. Benson
Carol C. Benson, M.A. Acting 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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Indications for Use
510(k) Number (if known):
Device Name: GlucoDr™ SuperSensor
Indications For Use:
The GlucoDr™ SuperSensor 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 from the fingertip.
The GlucoDr™ SuperSensor system may be used by healthcare professionals or for self testing by diabetic lay users in the home.
The GlucoDr"M SuperSensor system is not intended for the diagnosis of or screening for diabetes mellitus.
The GlucoDr™ SuperSensor system is not intended for use on neonates.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rute Chalen
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K052985