(449 days)
Not Found
No
The description details a standard electrochemical blood glucose monitoring system that measures current proportional to glucose concentration. There is no mention of AI/ML in the intended use, device description, or the specific sections for AI/ML information.
No
The device is described as a blood glucose monitoring system used for monitoring glucose levels, which is for diagnostic purposes, not for providing therapy or treatment.
Yes
This device is a diagnostic device because it monitors glucose in blood, which aids in monitoring the effectiveness of diabetes control. It performs testing outside the body (in vitro diagnostic use) to provide information about the user's health status.
No
The device description explicitly lists hardware components such as a blood glucose meter, test strips, control solution, and check strip, indicating it is a hardware-based system with associated software.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states:
- "Testing is done outside the body (in vitro diagnostic use)."
- "SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm." This describes testing a biological sample (blood) outside the body.
- "SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions." These are components used in the in vitro testing process.
These points clearly indicate that the device is intended for diagnostic testing performed on samples taken from the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions.
The SD Check Gold control solutions Level M and Level H are for use with SD Check Gold test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing newborns.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
SD CHECK GOLD blood glucose system is applicable to monitor blood glucose in capillary whole blood.
SD CHECK GOLD blood glucose monitoring system is comprised of the following.
- SD CHECK GOLD blood glucose meter
- SD CHECK GOLD blood glucose test strip i
- SD CHECK GOLD control solution -
- i SD CHECK GOLD check strip
A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, forearm or upper arm
Indicated Patient Age Range
Not Found. The system should not be used for testing newborns.
Intended User / Care Setting
home (over-the-counter; OTC) by person with diabetes, or in clinical settings by healthcare professionals
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
Image /page/0/Picture/0 description: The image shows the logo for Standard Diagnostics, Inc. The logo includes a stylized image of a plant or seed next to the letters "SD". To the right of the letters is the text "STANDARD DIAGNOSTICS, INC." and below that is "www.standarddia.com".
510(k) Summary
This summary of 510th) safety and effectiveness information is heing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _K082683.
DEC - 8 2009
SUBMITTER BY Standard Diagnostics, Inc. 156-68 Hagal-dong, Giheung-gu, Yongin-si, Kyonggi-do, Korea (Head Office) C-440&50 Floor Digital Empire Building 980-3, Yeongtong-dong (Manufacturing Site) Yeongtong-gu Suwon-si, Kyonggi-do Korea 82-31-899-9700 (PHONE) 82-31-899-9740 (FAX)
CONTACT PERSON
| (NAME) | William Greenros |
|---|---|
| (PHONE) | 603 369 3550 |
| (FAX) | 603 369 3562 |
DATE OF SUMMARY
April 21, 2008
DEVICE NAME
| (Proprietary Name) | SD CHECK GOLD |
|---|---|
| (Common Name) | Blood Glucose Monitoring System |
| (Regulation Number) | 21 CFR §862.1345 |
| (Classification Name) | Glucose Test System |
| (Product Code) | NBW |
| (Subsequent Product Code) | CGA / JJX |
| (Regulatory Class) | II |
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Image /page/1/Picture/0 description: The image shows the logo for Standard Diagnostics, Inc. The logo consists of a stylized plant-like graphic on the left, followed by the letters "SD" in bold font. To the right of "SD" is the text "STANDARD DIAGNOSTICS, INC." in a smaller, sans-serif font. Below this text is the website address "www.standarddia.com" in an even smaller font.
PREDICATE DEVICES
| Predicate Device 1 | Predicate Device 2 | |
|---|---|---|
| (510(k) Number) | K032552 | K024194 |
| (Device Name) | ACCU-CHEK ADVANTAGE SYSTEM | ONE TOUCH ® Ultra® |
| (Submitter by) | Roche Diagnostics Corporation | Lifescan, Inc. |
DEVICE DESCRIPTION
SD CHECK GOLD blood glucose system is applicable to monitor blood glucose in capillary whole blood.
SD CHECK GOLD blood glucose monitoring system is comprised of the following.
- SD CHECK GOLD blood glucose meter
- SD CHECK GOLD blood glucose test strip i
- SD CHECK GOLD control solution -
- i SD CHECK GOLD check strip
A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
INDICATION FOR USE
SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm.
SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions.
The SD Check Gold control solutions Level M and Level H are for use with SD Check Gold test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing newborns.
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COMPARISION TO PREDICATE DEVICE
The SD CHECK GOLD blood glucose monitoring system of Standard Diagnostics, Inc. is substantially equivalent to the current legally marketed ACC-CHEK Advantage System of Roche Diagnostics Corp and ONE TOUCH® Ultra® of Lifescan, Inc.
| Features | Details |
|---|---|
| Intended use | For self-testing blood glucose using capillary |
| whole blood | |
| Detection Method | Amperometry |
| System Verification | Control material to check the meter and test strip. |
| Function | Memory and Average of the test results |
| Power | One battery (CR 2032 type) |
CONCLUSION
The SD CHECK GOLD blood glucose monitoring system is substantially equivalent to predicated ACC-CHEK Advantage System (K032552) of Roche Diagnostics Corp and ONE TOUCH® Ultra®(K024194) of Lifescan, Inc.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, with three wavy lines representing the flow of life.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Standard Diagnostics. Inc. c/o Mr. William Greenrose Q Serve America, Inc. 220 River Road Claremont, NH 03743-0900
FC - 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K082683
Trade/Device Name: SD Check Gold Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 2, 2009 Received: December 4, 2009
Dear Mr. Greenrose:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/Medical】Devices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. 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 Statement
510(k) Number
Device Name
SD CHECK GOLD blood glucose monitoring system
INDICATIONS FOR USE
SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions.
The SD Check Gold control solutions Level M and Level H are for use with SD Check Gold test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing newborns.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use -(Part 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 Device (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082683