(260 days)
Not Found
No
The document describes a standard blood glucose monitoring system with data storage and transfer capabilities, but there is no mention of AI or ML being used for analysis, prediction, or interpretation of the glucose data. The performance studies focus on analytical and clinical accuracy, not on AI/ML model performance.
No.
The device is intended for "quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip" and acts "as an aid to monitor the effectiveness of diabetes control." It explicitly states it "should not be used for the diagnosis of or screening for diabetes." These uses are for monitoring, not for treating or preventing disease.
No
The device is explicitly stated as "not to be used for the diagnosis of or screening for diabetes." Instead, it is intended to "monitor the effectiveness of diabetes control."
No
The device description explicitly states the system includes "portable devices using a battery" and "meters," which are hardware components. The software is part of a larger system that includes physical hardware for measuring and displaying glucose levels.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "It 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."
This clearly indicates that the device is designed to be used outside of the body to test a biological sample (blood) for diagnostic purposes (monitoring glucose levels related to diabetes).
N/A
Intended Use / Indications for Use
GlucoDr.S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S Blood Glucose Test Strips are for use with GlucoDr.S Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S BLE Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. GlucoDr.S BLE Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S BLE Blood Glucose Test Strips are for use with GlucoDr.S BLE Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S NFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. GlucoDr.S NFC Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S NFC Blood Glucose Test Strips are for use with GlucoDr.S NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The subject systems are to measure and display glucose test results. The subject meters are portable devices using a battery with capability to store 500 test results in memory, and can search the stored test results with 7, 14, 30, 60, or 90-day average value of test results. This system provides beep, hypo/hyper warning limit, date/time setting, average period, and test reminder alarms settings.
The three systems which are GlucoDr.STM, GlucoDr.STM BLE, and GlucoDr.STM NFC are exactly the same devices except the data transfer features. The GlucoDr.S™ can transfer test results to a PC or to a smart device via a USB cable only, and the GlucoDr.S™M BLE offers Bluetooth data transfer features in addition to the USB cable port. The GlucoDr.S™ NFC offers NFC data transfer features in addition to the USB cable port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Not for use in neonates.
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes 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)
Bench studies including evaluation of analytical performance as well as clinical performance studies were conducted. Software verification testing was carried out to ensure all meter functions and displayed error messages perform as intended.
Precision Evaluation Study:
- Repeatability testing (CLSI EP05-A2): 5 venous blood samples (glucose concentrations spanning the measuring range), 10 replicates each with 3 test strip lots and 10 meters.
- Intermediate precision testing (CLSI EP05-A2): Over 14 days using 5 glucose control solutions, 10 replicates each with 3 test strip lots and 10 meters.
- Performance: GlucoDr.STM meter results compared to YSI 2300 analyzer.
- Key Results:
- Repeatability (Pooled STD below 4 mg/dL for low levels, CV below 4% for higher levels):
- Level 1 (39.1 mg/dL): STD 2.7, CV 6.3%
- Level 2 (85.5 mg/dL): STD 3.2, CV 3.9%
- Level 3 (121 mg/dL): STD 4.2, CV 3.7%
- Level 4 (205 mg/dL): STD 6.3, CV 3.4%
- Level 5 (352 mg/dL): STD 11.7, CV 3.7%
- Intermediate Precision (Pooled STD below 4 mg/dL for low levels, CV below 4% for higher levels):
- Level 1 (37.2 mg/dL): STD 1.4, CV 3.7%
- Level 2 (80.4 mg/dL): STD 1.8, CV 2.2%
- Level 3 (118 mg/dL): STD 2.6, CV 2.2%
- Level 4 (200 mg/dL): STD 3.5, CV 1.7%
- Level 5 (353 mg/dL): STD 7.4, CV 2.1%
- Repeatability (Pooled STD below 4 mg/dL for low levels, CV below 4% for higher levels):
- Conclusion: Performance is substantially equivalent to predicate devices.
Linearity Evaluation Study (CLSI EP6-A):
- 3 lots of GlucoDr.S™ blood glucose test strips.
- Venous blood samples spiked to 15 glucose concentrations ranging from 16 to 646.5 mg/dL.
- GlucoDr.S™ meter results compared to YSI 2300 analyzer.
- Key Results: Linear regression analysis resulted in mean slope ranging from 0.97622 to 0.99754 and R2 value of 0.99827 to 0.99951.
- Conclusion: Linearity between 20 and 600 mg/dL.
Interferences Endogenous/Exogenous Substances Study (CLSI EP7-A2):
- 30 potential interfering substances evaluated using 3 lots of test strips at 3 glucose concentrations of venous blood samples, 10 replicates each.
- Key Results: Max allowable limits for Dopamine (3 mg/dL), Gentisic acid (10 mg/dL), Maltose (5,000 mg/dL), Tolazamide (16 mg/dL), Xylose (11 mg/dL), and uric acid (8 mg/dL).
Interferences Hematocrit Study:
- Hematocrit levels evaluated using 3 lots of blood glucose test strips.
- Samples prepared ranging in HCT from 20 to 65% at 6 glucose concentration levels of venous blood samples, 10 replicates each.
- GlucoDr.S™ results compared to YSI 2300 analyzer.
- Key Results: Measurements were within acceptance criteria for the HCT range of 20-65%.
Sample Volume Study:
- 3 lots of blood glucose test strips.
- Venous blood samples tested at 4 glucose concentration levels and at 3 sample volumes ranging from 0.40 to 0.50 uL.
- Key Results: When sample volumes were less than 0.50µL, the GlucoDr.S™ meter displayed an error message. At 0.50µL, all results supported a minimum sample volume of 0.50 µL.
Other Bench Performance studies:
- Temperature and Humidity Effects: Meter and strips placed in environmental chambers (10-40℃ temperature, 15-85% RH). 3 test strip lots, 4 concentrations of blood samples, 10 replicates each. Compared to YSI 2300. Results support 10-40°C operating temperature and 15-85% RH.
- Altitude Effects: 4 concentrations of venous blood samples. Tested at altitudes between 0 and 10,020 ft. Compared to YSI 2300. Results support operation up to 10,020 ft.
- Cleaning and Disinfecting: Effect of CaviWipes Disinfecting Towelettes on five GlucoDr.S™ meters. No change in performance or external materials after cycles.
- Virucide Efficacy: Efficacy of disinfection against Hepatitis B virus (HBV) on GlucoDr.S™ meter materials using CaviWipe Disinfecting Towelettes (2 minutes contact). Demonstrated effective inactivation of HBV.
- Test Strip stability: Open vial and shelf life stability assessed using real time and accelerated studies. Results support claimed stability durations when stored at 4-30°C and 1-32°C (34-90°F) and 15-85% relative humidity.
- Readability Assessment of labeling: Flesch-Kincaid reading level for User's Manual and Test Strip Insert was at or below an 8th grade reading level.
Accuracy Studies - Lay User Study:
- Sample Size: 405 patients.
- Data Source: Capillary blood samples from patients.
- Performance: Evaluated by comparing GlucoDr.S™ Blood Glucose Monitoring System results with YSI Model 2300 STAT Plus Glucose Analyzer.
- Key Results:
- Glucose concentration
§ 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/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" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles or a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 13, 2017
ALL MEDICUS CO., LTD. C/O PRISCILLA CHUNG LK CONSULTING GROUP, USA, INC. 800 ROOSEVELT STE 417 IRVINE CA 92620
Re: K170241
Trade/Device Name: GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System GlucoDr.S NFC Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: September 12, 2017 Received: September 15, 2017
Dear Priscilla 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (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" (21 CFR 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,
Kellie B. Kelm -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
2
Indications for Use
510(k) Number (if known) K170241
Device Name
GlucoDr.S Blood Glucose Monitoring System
Indications for Use (Describe)
GlucoDr.S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S Blood Glucose Test Strips are for use with GlucoDr.S Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K170241
Device Name
GlucoDr.S BLE Blood Glucose Monitoring System
Indications for Use (Describe)
GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S BLE Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. GlucoDr.S BLE Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S BLE Blood Glucose Test Strips are for use with GlucoDr.S BLE Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K170241
Device Name
GlucoDr.S NFC Blood Glucose Monitoring System
Indications for Use (Describe)
GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S NFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. GlucoDr.S NFC Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S NFC Blood Glucose Test Strips are for use with GlucoDr.S NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
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) | ☒ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary (K170241)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 10/12/2017
1. Applicant / Submitter:
All Medicus Co., Ltd. No.7102-7107, 7402, 7403, 7406, 140, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14057, Republic of Korea Tel: 82-31-425-8288
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine, CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
-
Trade Name:
GlucoDr.STM Blood Glucose Monitoring System GlucoDr.STM BLE Blood Glucose Monitoring System GlucoDr.STM NFC Blood Glucose Monitoring System -
Classification Name: Blood Glucose Test System
-
Classification regulation: 21 CFR Part 862.1345
-
Product Code: NBW
4. Predicate Device:
GlucoDr. auto™ (K083628) by All Medicus Co., Ltd.
5. Description:
The subject systems are to measure and display glucose test results. The subject meters are portable devices using a battery with capability to store 500 test results in memory, and can search the stored test results with 7, 14, 30, 60, or 90-day average value of test results. This system provides beep, hypo/hyper warning limit, date/time setting, average period, and test reminder alarms settings.
The three systems which are GlucoDr.STM, GlucoDr.STM BLE, and GlucoDr.STM NFC are exactly the same devices except the data transfer features. The GlucoDr.S™ can transfer test
6
results to a PC or to a smart device via a USB cable only, and the GlucoDr.S™M BLE offers Bluetooth data transfer features in addition to the USB cable port. The GlucoDr.S™ NFC offers NFC data transfer features in addition to the USB cable port.
6. Indications for use:
GlucoDr.STM Blood Glucose Monitoring System
GlucoDr.STM Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.STM Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.STM Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S™ Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S™ Blood Glucose Test Strips are for use with GlucoDr.S™ Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
GlucoDr.STM BLE Blood Glucose Monitoring System
GlucoDr.S™ BLE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S"M BLE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S™ BLE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.STM BLE Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S™ BLE Blood Glucose Test Strips are for use with GlucoDr.S™ BLE Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
GlucoDr.STM NFC Blood Glucose Monitoring System
GlucoDr.S™ NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.STM NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.STM NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S™ NFC Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.STM NFC Blood Glucose Test Strips are for use with GlucoDr.S™ NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
7
7. Comparison to the Cleared Device
GlucoDr.S™, GlucoDr.S™ BLE, and GlucoDr.S™ NFC Blood Glucose Monitoring Systems are substantially equivalent to the GlucoD™ auto Blood Glucose Monitoring System (K083628) made by our company. The table below lists the similatities and differences between the subject devices and the predicate device.
| Subject Device | Predicative Device | |||
|---|---|---|---|---|
| Item | GlucoDr.STM | |||
| (AGM-513S) | GlucoDr.STM BLE | |||
| (ABM-513S) | GlucoDr.STM NFC | |||
| (ANM-513S) | GlucoDr. autoTM | |||
| (AGM-4000) | ||||
| 510k | K170241 | K170241 | K170241 | K083628 |
| Manufacturer | All Medicus | All Medicus | All Medicus | All Medicus |
| Intended Use | GlucoDr.STM Blood Glucose | |||
| Monitoring System | ||||
| GlucoDr.STM Blood Glucose | ||||
| Monitoring System is intended | ||||
| to be used for the quantitative | ||||
| measurement of glucose | ||||
| (sugar) in fresh capillary whole | ||||
| blood from fingertip. | ||||
| GlucoDr.STM Blood Glucose | ||||
| Monitoring System is intended | ||||
| to be used by a single person | ||||
| and should not be shared. It 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. |
GlucoDr.STM Blood Glucose
Monitoring System should not
be used for the diagnosis of or | GlucoDr.STM BLE Blood
Glucose Monitoring System
GlucoDr.STM BLE Blood
Glucose Monitoring System is
intended to be used for the
quantitative measurement of
glucose (sugar) in fresh
capillary whole blood from
fingertip. GlucoDr.STM BLE
Blood Glucose Monitoring
System is intended to be used
by a single person and should
not be shared. It 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.
GlucoDr.STM BLE Blood
Glucose Monitoring System
should not be used for the | GlucoDr.STM NFC Blood
Glucose Monitoring System
GlucoDr.STM NFC Blood
Glucose Monitoring System is
intended to be used for the
quantitative measurement of
glucose (sugar) in fresh
capillary whole blood from
fingertip. GlucoDr.STM NFC
Blood Glucose Monitoring
System is intended to be used
by a single person and should
not be shared. It 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.
GlucoDr.STM NFC Blood
Glucose Monitoring System
should not be used for the | The GlucoDr. autoTM blood
glucose monitoring system
system is intended for in vitro
diagnostic use (i.e., for
external use only) for
quantitative measurement of
glucose in venous, arterial
and capillary whole blood.
Testing sites include
traditional fingertip site along
with palm, upper arm,
forearm, thigh, and calf.
The GlucoDr. autoTM blood
glucose monitoring system
may be used by healthcare
professionals or for self
testing by diabetic lay users in
the mellitus at home as aid in
monitoring the effectiveness
of diabetes control program.
The GlucoDr. autoTM blood |
Similarities
510(k) Submission
8
| | screening for diabetes.
GlucoDr.SM Blood Glucose
Monitoring System is not for
use in neonates.
GlucoDr.SM Blood Glucose
Test Strips are for use with
GlucoDr.SM Blood Glucose
Meter to quantitatively
measure glucose (sugar) in
fresh capillary whole blood
samples drawn from the
fingertips. | diagnosis of or screening for
diabetes. GlucoDr.SM BLE
Blood Glucose Monitoring
System is not for use in
neonates.
GlucoDr.SM BLE Blood
Glucose Test Strips are for use
with GlucoDr.SM BLE Blood
Glucose Meter to quantitatively
measure glucose (sugar) in
fresh capillary whole blood
samples drawn from the
fingertips. | diagnosis of or screening for
diabetes. GlucoDr.SM NFC
Blood Glucose Monitoring
System is not for use in
neonates.
GlucoDr.SM NFC Blood
Glucose Test Strips are for use
with GlucoDr.SM NFC Blood
Glucose Meter to quantitatively
measure glucose (sugar) in
fresh capillary whole blood
samples drawn from the
fingertips. | glucose monitoring system is
not intended for the diagnosis
of or screening for diabetes
mellitus, nor intended for use
on neonates. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Detection
Method | Amperometry | Amperometry | Amperometry | Amperometry |
| Enzyme | Glucose Dehydrogenase | Glucose Dehydrogenase | Glucose Dehydrogenase | Glucose Dehydrogenase |
| Test Time | 5 seconds | 5 seconds | 5 seconds | 5 seconds |
| Sample Volumes | 0.5 μl | 0.5 μl | 0.5 μl | 0.5 μl |
| Test Range | 20 ~ 600 mg/dL | 20 ~ 600 mg/dL | 20 ~ 600 mg/dL | 20 ~ 600 mg/dL |
| Operation
temperature
range | 10 ~ 40 ℃ | 10 ~ 40 ℃ | 10 ~ 40 ℃ | 10 ~ 40 ℃ |
| Strip Storage
Condition | 1 ~ 32℃
1585%RH | 1 ~ 32 ℃85%RH | 1 ~ 32℃
15
15~85%RH | 1 ~ 32 ℃ |
| Battery Type | 3 V Lithium Battery (CR2032) | 3 V Lithium Battery (CR2032) | 3 V Lithium Battery (CR2032) | 3 V Lithium Battery (CR2032) |
| Memory
Capacity | 500 results with date and time | 500 results with date and time | 500 results with date and time | 500 results with date and time |
Difference
| Coding of Strip | no-coding | no-coding | no-coding | Auto-coding |
|---|---|---|---|---|
| Specimen Type | fresh capillary whole blood | fresh capillary whole blood | fresh capillary whole blood | Capillary and Venous blood |
| Hematocrit range | 20~65% | 20~65% | 20~65% | 20~60% |
| Operating | ||||
| Humidity Range | 15~85% | 15~85% | 15~85% | Below 85% |
510(k) Submission
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| Size of Meter | 87.3×50×17.5mm(LWH) | 87.3×50×17.5mm(LWH) | 87.3×50×17.5mm(LWH) | 93.5×49×17.5mm(LWH) |
|---|---|---|---|---|
| Weight of Meter | 47.2g(with battery) | 47.2g(with battery) | 47.2g(with battery) | 40g(with battery) |
| Altitude | 10,000feet | 10,000feet | 10,000feet | 8,202feet |
| Data transfer | Micro USB | Micro USB | ||
| BLE(Bluetooth Low Energy) | Micro USB | |||
| NFC(Near Field | ||||
| Communication) | USB |
There are a number of differences between the subject device as presented in the table above such as in coding, specimen type, hematocirt range, operating condition, size/weight of meter, etc..., however, the non-clinical-studies provided in this submission demonstrated that the differences do not raise a question of safety and effectiveness. Based on the information provided, we conclude that the subject devices are substantially equivalent to the predicate device.
10
8. Performance Data
Bench studies including evaluation of analytical performance as well as clinical performance studies were conducted. Software verification testing was carried out to ensure all meter functions and displayed error messages perform as intended.
- Precision Evaluation Study a.
Following CLSI EP05-A2, repeatability testing was conducted using 5 venous blood samples with glucose concentrations spanning the measuring range. Each measured in 10 replicates with 3 test strips lots and 10 meters. Intermediate precision testing was conducted over 14 days using 5 glucose control solutions each measured in 10 replicates with 3 test strips lots and 10 meters. GlucoDr.STM meter results of venous blood samples were compared to those obtained by the YSI 2300 analyzer as the reference method.
| Samples | Acceptance Criteria | Pooled STD (mg/dL) | Pooled CV (%) |
|---|---|---|---|
| Level 1 (39.1 mg/dL) | STD |