(244 days)
Not Found
No
The description focuses on standard amperometric technology for glucose measurement and does not mention any AI or ML components.
No.
The device measures blood glucose levels to monitor the effectiveness of a diabetes control program, but it does not treat or cure diabetes.
No
The device is explicitly stated as "not intended for the diagnosis of or screening for diabetes mellitus," indicating it is for monitoring purposes rather than initial diagnosis.
No
The device description explicitly lists multiple hardware components including a Meter, Test strips, Lancing device, Lancets, Code card, Battery, and Carrying case, indicating it is a hardware-based system with associated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative measurement of glucose in fresh capillary whole blood". This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The description details how the system works by analyzing a blood sample applied to a test strip, measuring an electrical current generated by a chemical reaction. This is a classic description of an in vitro diagnostic test.
- Components: The system includes components like test strips and control solutions, which are typical for IVD devices used for chemical analysis of biological samples.
N/A
Intended Use / Indications for Use
The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The EASY CHECK Control Solution is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the EASY CHECK Blood Glucose Monitor System.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
The EASY CHECK 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.
The EASY CHECK Blood Glucose Monitoring System consists of the Meter, Test strips with instructions, Lancing device with instructions, Lancets, Code card, 3-Volt Lithium Coin Battery, Users Guide, Log Book, Carrying case and EASY CHECK Control Solutions (level 1 and level 2)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, palm, forearm (capillary whole blood)
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home and healthcare facilities
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)
Non-Clinical Testing:
Sensitivity, precision, linearity and other tests were used to demonstrate the performance and reliability of EASY CHECK Blood Glucose Monitoring System. Meter also passed appropriate EMC requirements.
Clinical Testing:
Consumer (field) testing was done to prove that the EASY CHECK Blood Glucose Monitoring System is easy to use by lay people and also that test results are accurate and comparable to a laboratory reference method and to the predicate device.
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
Exhibit 3a
K062538
DIACARE CORP.
APR 3 0 2007
4977 E. La Palma Ave. Anaheim, CA 92807 Tel:(714) 970-7289
510(k) Summary
Administrative Information and Device Identification
| Name and address of sponsor of the 510(k) submission: | Diacare Corp.
4977 E. LA PALMA AVE.
ANAHEIM, CA 92807 |
|-------------------------------------------------------|--------------------------------------------------------------------------------|
| Official contact person for all correspondence: | Calvin Chang, calvin@evermed.com
Phone: (714) 970-7289; Fax: (714) 777-9978 |
| Date Prepared: | August 21, 2006 |
| Device Name: | EASY CHECK Blood Glucose Monitoring
System |
| Generic name of the device: | Blood Glucose Meter |
| Classification of new device: | Class II |
| Classification Panel: | Clinical Chemistry and Toxicology |
| Product Code and CFR Regulation Number: | NBW, CGA and 21 CFR 862.1345 |
| Predicate Device Name and 510(k) Number: | ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 |
1
Description of Device:
The EASY CHECK 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.
The EASY CHECK Blood Glucose Monitoring System consists of the Meter, Test strips with instructions, Lancing device with instructions, Lancets, Code card, 3-Volt Lithium Coin Battery, Users Guide, Log Book, Carrying case and EASY CHECK Control Solutions (level 1 and level 2)
Comparison of Device Technological Characteristics to Predicate Device:
EASY CHECK Blood Glucose Monitoring System and ASCENSIA ELITE DIABETES CARE SYSTEM are similar in many respects. Among other similarities, they use the same detection method, enzyme, mediator and basic electrode material.
Differences include the Hematocrit range, temperature range, test time and sample volume. Tests included in this 510(k) submission have incorporated these changes and results show that they introduce no new questions on the safety and effectiveness of the EASY CHECK Blood Glucose Monitoring System.
| Item | Device | Predicate |
|---|---|---|
| Easycheck | Bayer Elite | |
| Detection | ||
| Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Mediator | Potassium Hexacyanoferrate | Potassium Hexacyanoferrate |
| Electrode | Carbon | Carbon |
| Coding | Code key | Code Key |
| Sample type | whole blood | whole blood |
| Humidity | 20%-80% | 20%-80% |
Similarities:
2
| Power Supply | 3V lithium battery (CR2032) | 3V lithium battery (CR2032) |
|---|---|---|
| Battery lifetime | Over 1000 tests | Over 1000 tests |
| Weight | 50 g | 50 g |
Differences:
| Temp. Range | 2-30 □
36-86 □ | 15-30 □
60-86 □ |
|--------------------|-----------------------------|--------------------|
| Hct Range | 30%-50% | 20%-60% |
| Test Range | 30-600 mg/dL | 20-600 mg/dL |
| Test time | 9 second | 30 second |
| Sample volume | 1.5 μL | 3 μL |
| Test sample | fingertip, palm and forearm | fingertip |
| Memory | 180 sets | 20 sets |
| Meter
dimension | 58x80x19 mm | 81x51x14 mm |
Intended Use:
The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Non-Clinical Testing:
Sensitivity, precision, linearity and other tests were used to demonstrate the performance and reliability of EASY CHECK Blood Glucose Monitoring System. Meter also passed appropriate EMC requirements.
Clinical Testing:
3
Consumer (field) testing was done to prove that the EASY CHECK Blood Glucose Monitoring System is easy to use by lay people and also that test results are accurate and comparable to a laboratory reference method and to the predicate device.
Conclusion:
Detailed testing has confirmed that the EASY CHECK Blood Glucose Monitoring System is substantially equivalent to the predicate device and that the differences do not bring up any new safety or effectiveness concerns.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Diacare Corp. c/o Mr. Sid Mathur MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
APR 3 0 2007
K062538 Re:
Trade/Device Name: Easy Check Blood Glucose Monitoring System and Easy Check Glucose Control Solution Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: April 2, 2007 Received: April 3, 2007
Dear Mr. Mathur:
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), and 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).
5
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.
Jean 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
6
Indications for Use
510(k) Number (if known): K062538
Device Name: EASY CHECK Blood Glucose Monitoring System
Indications for Use: The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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)
CFC
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
SK062538
7
Indications for Use
510(k) Number (if known): K062538
Device Name: EASY CHECK Glucose Control Solution
Indications for Use: The EASY CHECK Control Solution is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the EASY CHECK Blood Glucose Monitor System.
Prescription Use ﺴﮯ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
tion Sign-Off
Affice of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1