(210 days)
No
The description focuses on an "auto-coding function" which automatically recognizes the test strip code. This is a simple automation feature, not indicative of AI or ML. There is no mention of learning, adaptation, or complex pattern recognition.
No
The device is described as a "Diabetes Monitoring System" used for "quantitative measurement of glucose level in whole blood" to aid in "monitoring the effectiveness of diabetes management." It does not provide treatment.
Yes
The "Intended Use / Indications for Use" states that the system is used for "quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management." This clearly identifies it as a diagnostic device designed to provide information for medical decision-making. Furthermore, it explicitly states "in vitro diagnostic use only."
No
The device description explicitly states that the system is comprised of a test meter, test strip, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The GLUCOLAB Auto-coding 100 System is for testing outside the body (in vitro diagnostic use only)."
This statement directly identifies the device as being used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The GLUCOLAB Auto-coding™ 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 Auto-coding™ System provides plasma equivalent results. The GLUCOLAB Auto-coding™ System is not intended to be used with neonatal blood samples. The GLUCOLAB Auto-coding™ 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 Auto-coding™ control is used with GLUCOLAB Auto-coding™ 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 do control solution tests routinely to make sure you are getting accurate results.
Product codes
NBW, CGA, JJX
Device Description
GLUCOLAB Auto-coding 114 Blood Glucose Monitoring System is comprised of test meter, test strip and control solutions. GLUCOLAB Auto-coding™ Blood glucose test meter is substantially identical with the predicated device (GlucoLab™: K051285). The minor difference is that the GLUCOLAB Auto-coding™ test meter has auto-coding function, which GlucoLab ™ test meter does not have. GLUCOLAB Autocoding 1 test meter can recognize the code of the test strips automatically. This function is intended to decrease user's incorrect code matching.
GLUCOLAB Auto-coding™ blood glucose test strip is identical with the predicated device (GlucoLab™) K051285) except code recognition band at the back side of the strip. This code recognition band is for auto-coding function of GLUCOLAB Auto-coding™ test meter.
GLUCOLAB Auto-coding™ glucose control solutions are exactly same as GlucoLab™ control solutions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Traditional fingertip, forearm, upper arm, palm, calf and thigh.
Indicated Patient Age Range
Not intended to be used with neonatal blood samples.
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
Clinical: The clinical performance evaluation using the GLUCOLAB Auto-coding™ Blood Glucose Monitoring System components were conducted for purpose of validating the consumer use for the user and the professional accuracy. Test results showed substantial equivalence.
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the GLUCOLAB Auto-coding™ Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Key Metrics
Not Found
Predicate Device(s)
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
510(K) Summary
This summary of 510(k) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
- Application date: 04/17/09
2. Submitter Information
Infopia Co.,Ltd.
#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 NOV 1 7 2009
3. U.S Agent/Contact Person
13340 E Firestone Blvd. Suite J, Santa Fe Springs, CA 90670 Phone: 562-404-8466 Fax: 562-404-2757 Priscilla Juhee Chung Email: agent.fda@gmail.com
GLUCOLAB Auto-coding™ (IGM-0022) 4. Trade name:
5. Classification:
Class II
Glucose test system (21 CFR Part 862.1345, NBW/CGA) Quality control material (assayed and unassayed) (21 CFR Part 862.1660, JJX)
6. The legally marketed (Unmodified) Device / Predicate
GLUCOLAB™ (K051285) Blood Glucose Monitoring System, Infopia co., Ltd.
7. Device Description
GLUCOLAB Auto-coding 114 Blood Glucose Monitoring System is comprised of test meter, test strip and control solutions. GLUCOLAB Auto-coding™ Blood glucose test meter is substantially identical with the predicated device (GlucoLab™: K051285). The minor difference is that the GLUCOLAB Auto-coding™ test meter has auto-coding function, which GlucoLab ™ test meter does not have. GLUCOLAB Autocoding 1 test meter can recognize the code of the test strips automatically. This function is intended to decrease user's incorrect code matching.
1
GLUCOLAB Auto-coding™ blood glucose test strip is identical with the predicated device (GlucoLab™) K051285) except code recognition band at the back side of the strip. This code recognition band is for auto-coding function of GLUCOLAB Auto-coding™ test meter.
GLUCOLAB Auto-coding™ glucose control solutions are exactly same as GlucoLab™ control solutions.
8. Intended Use
The GLUCOLAB Auto-coding™ 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 Auto-coding "System provides plasma equivalent results. The GLUCOLAB Autocoding The System is not intended to be used with neonatal blood samples. The GLUCOLAB Autocoding™ 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 Auto-coding "" control is used with GLUCOLAB Auto-coding™ 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 do control solution tests routinely to make sure you are getting accurate results.
Control Solutions are sold separately.
9. Comparison to the Cleared Device
The technological characteristics of the revised device (GLUCOLAB Auto-coding™) in comparison to the predicated devices (GlucoLab Th). The modified device has the same technological characteristics as the current legally marketed predicated device, GlucoLab™ (K051285) by Infopia Co., Ltd.
10. Performance Data
Clinical: The clinical performance evaluation using the GLUCOLAB Auto-coding™ Blood Glucose Monitoring System components were conducted for purpose of validating the consumer use for the user and the professional accuracy. Test results showed substantial equivalence.
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the GLUCOLAB Auto-coding™ Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.
11. Conclusion
The conclusion drawn from the clinical and nonclinical tests is that the GLUCOLAB Autocoding™ Blood Glucose Monitoring System is as safe, as effective and performs as well as the legally marketed predicated device, the GlucoLab™(K051285).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a wing-like structure above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Infopia CO.. Ltd c/o Ms. Priscilla Chung 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670
NOV 1 7 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K091157
Trade/Device Name: GLUCOLAB Auto-coding 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: October 23, 2009 Received: October 27, 2009
Dear Ms. Chung:
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 (OS) 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/MedicalDevices/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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Indication for Use
510(k) Number (if known): K091157
Device Name: GLUCOLAB Auto-coding™ Blood Glucose Monitoring System
Indication For Use:
The GLUCOLAB Auto-coding TM 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 Auto-coding™ System provides plasma equivalent results. The GLUCOLAB Auto-coding 100 System is not intended to be used with neonatal blood samples. The GLUCOLAB Auto-coding 100 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 Auto-coding™ control is used with GLUCOLAB Auto-coding™ 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 do control solution tests routinely to make sure you are getting accurate results.
Control Solutions are sold separately.
Prescription Use V (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 (OVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091157