(511 days)
No
The device description details a standard electrochemical biosensor system that measures current and applies a formula based on implicit coding. There is no mention of AI, ML, or any learning algorithms.
No.
A therapeutic device is used to treat a disease or condition. This device is an in vitro diagnostic device used for monitoring blood glucose levels to aid in managing diabetes, not for treatment.
No
The device is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The text explicitly states: "The FIA Blood Glucose Monitoring System (G2) should not be used for the diagnosis of or screening of diabetes or for neonatal use."
No
The device description explicitly lists hardware components such as a Glucose Meter, Glucose Test Strips, and a Check Strip, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The FlA Blood Glucose Monitoring System (G2) is intended for self testing outside the body (in vitro diagnostic use)..." and "The FIA Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only)..."
- Nature of the Test: The system measures glucose in a blood sample outside the body, which is the definition of an in vitro diagnostic test.
- Purpose: The purpose is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The FIA Blood Glucose Monitoring System (G2) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The FIA Blood Glucose Monitoring System (G2) is intended to be used by a single patient and should not be shared.
The FIA Blood Glucose Monitoring System (G2) is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FIA Blood Glucose Monitoring System (G2) should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The FIA Blood Glucose Test Strips (G2) are for use with the FIA Blood Glucose Meter (G2) to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The FIA Glucose Control Solutions are for use with the FIA Blood Glucose Meter (G2) and FIA Blood Glucose Test Strips (G2) to check that the meter and test strips are working together properly and that the test is performing correctly.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX, JQP
Device Description
FIA Blood Glucose Monitoring System (G2) consists of:
- (1) Glucose Meter
- (2)Glucose Test Strips
- (3)Two levels of glucose control solutions (L1 and L2) may be purchased separately. Glucose control solutions were previously cleared under K032985.
- (4)Check Strip
- (5)Instruction for use
[Test Principle]
FIA Blood Glucose Monitoring System (G2) is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The FIA Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the FIA Blood Glucose monitoring system (G2) and FIA Blood Glucose Test strips (G2). There are two levels of controls (L1 and L2).
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips only
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single patient, 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)
FIA Blood Glucose Monitoring System (Subject Device) is compliant to the standard of ISO 15197:2003 In vitro diagnostic test systems-Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met.
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.
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
510(k) Summary
-
- Submitter Information
| Company name: | HMD BioMedical Inc. |
|---|---|
| Contact person: | Axel Lin |
| Address: | No. 181, Minsheng St., Xinpu Township, Hsinchu |
| County, Taiwan | |
| Phone: | 886-3-6017000 |
| FAX: | 886-3-5885500 |
| E-mail: | axellin@hmdbio.com |
| Date Prepared: | Sep 17, 2014 |
-
- Name of Device
Trade/Proprietary Name:
- Name of Device
FIA Blood Glucose Monitoring System (Model no.: G2)
| Common name: | Blood Glucose Test System |
|---|---|
| Classification name: | Glucose Test System |
| Classification Panel: | Clinical Chemistry (75) |
| Regulation no.: | 862.1345 (Class II), 862.1660 (Class I) |
| Product code: | NBW, LFR, JJX, JQP |
-
- Predicate Device
| Trade/Proprietary name: | PRECICHEK Cloudia Blood Glucose
Monitoring System |
|-------------------------|------------------------------------------------------|
| Common name: | Blood Glucose Test System |
| Submitter: | HMD BioMedical Inc. |
| 510(k) no.: | K120064 |
| Product code: | NBW. LFR |
1
HMD BioMedical Inc.
| Common name: | Glucose Control Solution |
|---|---|
| Submitter: | HMD BioMedical, Inc. |
| 510(k) no.: | K032985 |
| Product code: | JJX |
-
- Device Description
FIA Blood Glucose Monitoring System (G2) consists of:
- Device Description
-
(1) Glucose Meter
-
(2)Glucose Test Strips
-
(3)Two levels of glucose control solutions (L1 and L2) may be purchased separately. Glucose control solutions were previously cleared under K032985.
-
(4)Check Strip
-
(5)Instruction for use
[Test Principle]
FIA Blood Glucose Monitoring System (G2) is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The FIA Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the FIA Blood Glucose monitoring system (G2) and FIA Blood Glucose Test strips (G2). There are two levels of controls (L1 and L2).
2
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.
5. Intended Use
The FIA Blood Glucose Monitoring System (G2) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The FIA Blood Glucose Monitoring System (G2) is intended to be used by a single patient and should not be shared.
The FIA Blood Glucose Monitoring System (G2) is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FIA Blood Glucose Monitoring System (G2) should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The FIA Blood Glucose Test Strips (G2) are for use with the FIA Blood Glucose Meter (G2) to quantitatively measure qlucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The FIA Glucose Control Solutions are for use with the FIA Blood Glucose Meter (G2) and FIA Blood Glucose Test Strips (G2) to check that the meter and test strips are working together properly and that the test is performing correctly.
-
- Comparison of Subject Devices and predicate device
Technological Characteristics Comparison Table of FIA Blood Glucose Monitoring System (G2) and PRECICHEK Cloudia Blood Glucose Monitoring System (K120064)
- Comparison of Subject Devices and predicate device
3
HMD BioMedical Inc.
| Similarities | ||
|---|---|---|
| Item | Subject device | |
| FIA BGMS (G2) | Predicate device | |
| PRECICHEK Cloudia BGMS (K120064) | ||
| Intended use | It is designed to quantitatively measure the concentration of glucose in fresh capillary whole blood. | Same |
| Detection method | Amperometry: Current produced by chemical reaction | Same |
| Test range | 20~600mg/dL | Same |
| Operating conditions | 50 | Same |
| Autocoding | Yes | Same |
| Enzyme | Glucose Dehydrogenase (FAD) (Aspergillus oryzae) | Same |
| Capillary testing site | Fingertips only | Same |
| Sample volume | 0.5ul | Same |
| Memory | 999 | Same |
| Test time | 5 sec | Same |
| Time & date setting | Reload the batteries then press the buttons to set the time and date. | Same |
4
HMD BioMedical Inc.
| Differences | ||
|---|---|---|
| Item | Subject device | |
| FIA BGMS (G2) | Predicate device | |
| PRECICHEK Cloudia BGMS | ||
| (K120064) | ||
| Data | ||
| transmission | GSM | N/A |
| Average | N/A | 7, 14, 21, 28 days |
7. Discussion of Clinical Tests Performed
FIA Blood Glucose Monitoring System (Subject Device) is compliant to the standard of ISO 15197:2003 In vitro diagnostic test systems-Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. All the relevant activities were performed by professionals and the results demonstrated that the predetermined acceptance criteria were fully met.
8. Conclusion
The subject device was tested and fulfilled the requirements from those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate device.
5
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2014
HMD BIOMEDICAL, INC. AXEL LIN MANAGER OF QUALITY ASSURANCE #181 MINSHENG STREET, XINPU TOWNSHIP, HSINCHU COUNTY, TW 305 TAIWAN
Re: K131173 Trade/Device Name: FIA Blood Glucose Monitoring System (G2) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: September 5, 2014 Received: September 8, 2014
Dear Ms. Lin:
This letter corrects our substantially equivalent letter of September 25, 2014. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 - Ms. Lin
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known) K131173
Device Name FIA Blood Glucose Monitoring System (G2)
Indications for Use (Describe)
The FIA Blood Glucose Monitoring System (G2) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The FIA Blood Glucose Monitoring System (G2) is intended to be used by a single patient and should not be shared.
The FlA Blood Glucose Monitoring System (G2) is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FIA Blood Glucose Monitoring System (G2) should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The FIA Blood Glucose Test Strips (G2) are for use with the FIA Blood Glucose Meter (G2) to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The FIA Glucose Control Solutions are for use with the FIA Blood Glucose Meter (G2) and FIA Blood Glucose Test Strips (G2) to check that the meter and test strips are working together properly and that the test is performing correctly.
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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