(77 days)
Not Found
No
The description focuses on the electrochemical principle of glucose measurement and does not mention any AI or ML components.
No
The device is used for monitoring glucose levels, which aids in managing diabetes, but it does not directly treat or provide therapy for the condition itself.
Yes
The "Intended Use / Indications for Use" section states: "The GLUCOLAB™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings." This indicates its use in providing information to aid in the management of a medical condition. The "Device Description" also explicitly states it is an "in vitro diagnostic device".
No
The device description explicitly mentions a "GLUCOLAB™ Monitor" and "GLUCOLAB™ Test Strips," which are hardware components used for measuring glucose concentration. The principle of the test involves an electrochemical signal generated by the test strip and measured by the Meter. This indicates the device is a system that includes both hardware and software, not software-only.
Yes, the GLUCOLAB™ Diabetes Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states, "The GLUCOLAB™ System is for testing outside the body (in vitro diagnostic use only)."
- Device Description: The "Device Description" section also explicitly states, "The GLUCOLAB™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood..." and "This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood."
- Nature of the Test: The system measures glucose levels in a biological sample (whole blood) outside of the body to provide information about a person's health status (diabetes management). This is the fundamental definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The GLUCOLAB™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings., including physician's office laboratories and point of care sites. The GLUCOLAB™ System provides plasma equivalent results. The GLUCOLAB™ System is not intended to be used with neonatal blood samples. The GLUCOLAB™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you are getting accurate results.
Control Solutions are sold separately
Product codes
CGA, NBW, JJX
Device Description
The GLUCOLAB™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the GLUCOLAB™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Traditional fingertip testing along with alternate site testing on the arm, palm, calf and thigh.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and in clinical settings, including physician's office laboratories and point of care sites.
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)
K024194 – LifeScan, Inc. OneTouch® Ultra®, K984261 – LifeScan, Inc. SURESTEP®, K021513 – Roche Diagnostics Corp. Accu-Chek Advantage
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Infopia, Co., Ltd.
510(k) for In Vitro Diagnostic Device
KOS/28)
510(k) SUMMARY (As required by 21.CFR.807.92) According to the requirements of 21 CFR.807.92, the following Introduction: information provides sufficient data to understand the basis for a determination of substantial equivalence. Infopia Co., Ltd. Submitted By: No. 1603, Dongil Technotown A bldg., 889-3 Kwanyang2-dong, Dongan-gu, Anyang Kyunggi, 431-716 Korea Phone: 82-31-423-6170 Fax: 82-31-423-6171 Byeong Woo, Bae Contact Person: Phone: 82-31-423-6170 Fax: 82-31-423-6171 Date Summary, Prepared: May 16, 2005 Propriety Name: GLUCOLABTM Device Name: Common Name: Blood Glucose Test System Classification Name: Class II, 862.1345 Glucose Blood Tester Predicate Device: We claim substantial equivalence to the LifeScan, Inc., OneTouch® Ultra®. Device GLUCOLAB™ Monitor is an in vitro diagnostic device Description: The designed for measuring the concentration of glucose in whole blood, which is used with the GLUCOLAB™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result. The GLUCOLABTM Diabetes Monitoring System is used for the Intended Use: quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. GLUCOLABTM System is for
1
Infopia, Co., Ltd. 510(k) for In Vitro Diagnostic Device
510(k) Summary, Continued
| | testing outside the body (in vitro diagnostic use only). Testing
sites include the traditional fingertip testing along with alternate
site testing on the arm, palm, and thigh giving it an attractive,
nearly painless alternative to the more painful fingertip site. . |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate Device: | The Infopia Co., Ltd. GLUCOLAB™ Module is substantially
equivalent to the other products in commercial distribution
intended for similar use. The most notable, it is substantially
equivalent to the currently marketed item, the OneTouch® Ultra®
by LifeScan, Inc. |
| Conclusion: | The GLUCOLAB™ Blood Glucose Monitoring System is
substantially equivalent to the following predicate devices:
K024194 – LifeScan, Inc. OneTouch® Ultra®
K984261 – LifeScan, Inc. SURESTEP®
K021513 – Roche Diagnostics Corp. Accu-Chek Advantage |
:
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
AUG 2 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Infopia Co., Ltd. C/O Edward Letko American Healthcare, Inc. 304 Park Avenue South Suite 218 New York, NY 10010
$\pm$
Re: K051285
Trade/Device Name: Glucolab™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: May 16, 2005 Received: May 17, 2005
Dear Mr. Letko:
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 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 yours,
Carol C. Benam
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
4
Infopia, Co., Ltd. 510(k) for In Vitro Diagnostic Device
Indications for Use
K651285 510(k) Number:
Device Name: GLUCOLAB™
The GLUCOLAB™ Diabetes Monitoring System is used for the Indications For Use: Indications for ose. - The Occose level in whole blood as an aid in monitoring the quartitative "measurent in the home and in clinical settings., including physician's office laboratories and point of care sites . The GLUCOLAB™ System provides plasmaonlice laboratories and point of care System is not intended to be used with neonatal blood equivalent Tesalla. The OEM System is for testing outside the body (in vitro diagnostic use only). Samples. The GEOOOE.ID - Oyclorial is top tosting along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips Oldcorab - online is a system and that you are performing the test correctly. It is very are working together as a system and that you are getting accurate results.
Control Solutions are sold separately
Prescription Use (Part 21 CFR 801 Subpart D)
Image /page/4/Picture/8 description: The image shows the text "AND/OR". The word "AND" is circled. The text is written in black ink on a white background.
Over-The-Counter Use X (21 CFR 807 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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
vision/Sign-Off
ffice of In Vitro Diagnostic Device valuation and Safety
10(k) 051285