(269 days)
Not Found
No
The description focuses on standard electrochemical blood glucose monitoring technology and does not mention any AI or ML components.
No
The device is a diagnostic tool used to monitor blood glucose levels, not to treat a condition. Its intended use explicitly states "in vitro diagnostic use" and "as an aid in monitoring the effectiveness of a diabetes control program," rather than actively treating diabetes.
Yes
The "Intended Use / Indications for Use" states that the system is "intended for in vitro diagnostic use."
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, control solutions, lancets, and a lancing device, which are all hardware components.
Yes, the provided text explicitly states that the AG-605 & AG-606 Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here are the key phrases from the text that confirm this:
- "AG-605 & AG-606 Blood Glucose Monitoring System is intended for in vitro diagnostic use." (from Intended Use / Indications for Use)
- "Testing is done outside the body (In Vitro diagnostic use)." (from Intended Use / Indications for Use)
N/A
Intended Use / Indications for Use
AG-605 & AG-606 Blood Glucose Monitoring System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
AG-605 & AG-606 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, JJX
Device Description
AG-605 & AG-606 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, two levels of control solutions, lancets and lancing device.
AG-605 & AG-606 Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips (for capillary whole blood sample)
Indicated Patient Age Range
Not for use on neonates.
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home; lay uses by people with diabetes and in a clinical setting by health care 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
Clinical tests were performed and complied the accuracy requirements of ISO 15197. The results meet or exceed the accuracy requirements of ISO 15197.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical tests were performed and complied the accuracy requirements of ISO 15197. The results meet or exceed the accuracy requirements of ISO 15197.
Non-clinical tests coincide the following standards, including Product Safety test and Electromagnetic Compatibility test: IEC 61010-1-2001, IEC 61010-2-101-2002, EN 61326.
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
510(k) Summary
JUL 2 1 2008
ldentification of the submitter:
| Submitter: | Andon Health Co., LTD
No 31, Changjiang Road, Nankai District, Tianjin,
P.R. China, 300193 |
|----------------------|--------------------------------------------------------------------------------------------------|
| Telephone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 08/10/07 |
Identification of the product:
| Trade name: | AG-605 Blood Glucose Monitoring System
AG-606 Blood Glucose Monitoring System | |
|-----------------|-----------------------------------------------------------------------------------------------|--|
| Common name: | Glucose test System | |
| Classification: | Blood Glucose Meter and test strip are Class II
devices (21 CFR 862.1345, Glucose Monitor) | |
| Product code: | CGA | |
Predicate Device:
One Touch Ultra Blood Glucose Monitoring system of Life Scan
K024194 510k number:
Device description:
AG-605 & AG-606 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, two levels of control solutions, lancets and lancing device.
AG-605 & AG-606 Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample.
1
Intended use:
AG-605 & AG-606 Blood Glucose Monitoring System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Comparison to Predicate Devices(s):
:
| CHARACTERISTICS | NEW DEVICE:
AG-605 & AG-606 Blood
Glucose Monitoring System | PREDICATE:
One Touch Ultra Blood
Glucose Monitoring system
(K024194) |
|-----------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Intended Use | To quantitatively measure glucose
in fresh capillary whole blood. | To quantitatively measure glucose
in fresh capillary whole blood. |
| Sample Source | Capillary whole blood | Capillary whole blood |
| Sample Application | Blood sample is placed directly to
the test strip after finger is lanced. | Blood sample is placed directly to
the test strip after finger is lanced. |
| Hematocrit Range | 30-55% | 30-55% |
| Operating Temperature Range | 10℃40℃(50°-104°F) | 6℃33.3mmol/L) |44℃(43°-111°F) |33.3mmol/L) | 20mg/dL-600mg/dL
| Dimensions | AG-605: 50mmx 112mmx 22mm
AG-606: 82 mm×59mm × 20mm | 3.12" X2.25" X0.85" |
| Weight | AG-605: 60g (exclude batteries)
AG-606: 55g (exclude batteries) | 1.5 ounces (43g) with battery |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | AG-605: 160 times with time and
date displaying
AG-606: 350 times with time and
date displaying | 150 blood glucose and control
solution tests |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC3V (2XAAA batteries) | One replaceable 3.0v lithium
battery |
| Battery Life | Approx. 1000 normal tests | 1000 tests |
| Measurement Range | 20mg/dL-600mg/dL
(1.1mmol/L
(1.1mmol/L
| Qualified Test Strip | AGS-600 Test Strip | ONETOUCH Ultra Test Strip |
| Sample Volume | Minimum 1 micro liter | Minimum 1 micro liter |
2
Summary:
The information provided in this pre-market notification demonstrates that AG-605 & AG-606 Blood Glucose Monitoring System is substantially equivalent to One Touch Ultra Blood Glucose Monitoring system. Substantial equivalent was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the AG-605 &AG-606 Blood Glucose Monitoring System is safe and effective for its stated intended use.
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ISO 15197. The results meet or exceed the accuracy requirements of ISO 15197.
Non-clinical Tests:
All non-clinical tests coincide the following standards, including Product Safety test and Electromagnetic Compatibility test.
IEC 61010-1-2001
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements
IEC 61010-2-101-2002
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
EN 61326
Electrical equipment for measurement, control and laboratory use -EMC requirements
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings forming a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Andon Health Co., Ltd. c/o Ms. Mona Technologi Department 7th Floor Hua Qiao Chuang Ye Plaza No. 10 JinPing Road, Ya An Road Nankai District, Tianjin, P.R. China 300193
JUL 2 1 2008
Re: K073030
Trade Name: AG-605 Blood Glucose Monitoring System, AG-606 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: July 9, 2008 Received: July 14, 2008
Dear Mona:
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).
4
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K073030
Device Name: AG-605 Blood Glucose Monitoring System AG-606 Blood Glucose Monitoring System
Indication For Use:
AG-605 & AG-606 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.
Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use Yes (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073036