(87 days)
No
The description focuses on standard electrochemical biosensor technology for glucose measurement and does not mention any AI or ML components.
No
Explanation: This device is a blood glucose monitoring system, intended for measurement and monitoring, not for treating or curing a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the test strips are "for testing outside the body (in vitro diagnostic use)." It also mentions that the system is intended "as an aid in monitoring the effectiveness of diabetes control," which is a diagnostic purpose.
No
The device description explicitly mentions a "meter" and "test strip," which are hardware components used for measuring glucose. The system relies on these physical parts to function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro . diagnostic use)."
- Definition of IVD: An in vitro diagnostic device is a medical device used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This device measures glucose in blood samples.
- Intended Use: The intended use is to quantitatively measure glucose in fresh capillary whole blood, which is a biological sample tested outside the body.
Therefore, based on the provided text, the Easy Step / DIACHEX PRO Blood Glucose Monitoring System is an IVD.
N/A
Intended Use / Indications for Use
The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.
Product codes
75CGA, 75NBW
Device Description
The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. Easy Step / DIACHEX* PRO provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.
The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). When the edge of the test strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 5 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The test strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, forearm
Indicated Patient Age Range
Not intended for neonatal testing.
Intended User / Care Setting
Home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Within day precision test: Performed with 5 levels of spiked whole blood, 100 measurements obtained from 10 meters with each level of blood sample.
Linearity test: Performed with 10 levels of spiked whole blood, 10 measurements obtained from 10 meters with each level of blood sample using one lot test strip. The linear response range of proposed meter was defined from 20 to 600 mg/dL. and the actual studies were performed from ~25 to ~566 mg/dL.
Clinical accuracy: Assessed in an in-house study performing by technician. 129 participants (males and females) with sample ranged from 33.2 to 577mg/dL and hematocrit ranged from 34% to 53%. Values obtained from meters were compared to YSI results. The alternate site testing was also been evaluated.
Key Results: The acceptable criteria is the ISO 15197 requirement of 95% of individual glucose results falling within ±15mg/dL at glucose concentration for samples
§ 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.
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510(k) SUMMARY
1. DATE PREPARED
February 20, 2009
JUN - 4 2009 2. SPONSOR INFORMATION
Address
TYSON BIORESEARCH. INC.
5 F., # 22, KE E. ROAD III., SCIENCE BASED INDUSTRIAL PARK CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350
Contact Person: WEN-HAI TSAI
BHONE: 886-37-585988 FACSIMILE: 886-37-585996
3. NAME OF DEVICE:
Trade Name:
Easy Step Blood Glucose Monitoring System DIACHEX* PRO Blood Glucose Monitoring System
Common Names/Descriptions: Blood Glucose Monitoring System Classification Names: Glucose test system, product code 75CGA and "System, test, blood glucose, over the counter", product code 75NBW, 21 CFR 862.1345
4. DEVICE DESCRIPTION:
The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. Easy Step / DIACHEX* PRO provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.
The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the
1
body (in vitro diagnostic use). When the edge of the test strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 5 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The test strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.
5. INTENDED USE:
The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.
6. TEST PRINCIPLE
The test principle is based on electrochemical biosensor technology using glucose oxidase. Glucose is oxidized to gluconic acid and electrons are produced from the reaction. The electrons are then trapped by a chemical mediator, potassium ferricyanide. Once the enzymatic reaction is complete, a potential is provided by the meter for a further electrochemical reaction in order to generate a current from the release of trapped electrons. This current is then measured and correlated to the glucose concentration in the whole-blood sample. The test strip is calibrated to display the equivalent of plasma glucose values to allow easy comparison of results with laboratory methods.
7. PREDICATE DEVICE:
Predicate device name(s): DIACHEX* INFINITY Blood Glucose Monitoring System
Predicate 510(k) number(s): K073492
Comparison with predicate:
This 510(K) amendment addresses the changes of the DIACHEX* INFINITY Blood
2
Glucose Monitoring System (K073492). The modifications encompass the change for operating process, addition of selectable backlight on/off function, addition of graphic indicator for pre-meal and post-meal test results on the LCD result display of Easy Step / DIACHEX* PRO meter and the removal of hypoglycemic and hyperglycemic alarm setting function and the change for meter outside looking of Easy Step Glucose meter only. All the main internal electronic component, function and detection algorithm of proposed devices remain the same as DIACHEX* INFINITY Blood Glucose Meter. The chemical formula and used enzyme of the Easy Step / DIACHEX* PRO test strip is identical to the original cleared device test strip (K062829) without ant change. The table below lists the differences between the Easy Step and DIACHEX* PRO device from the predicate DIACHEX* INFINITY device.
| Item | Predicate Device (K073492) | Proposed Device | |
|---|---|---|---|
| DIACHEX* INFINITY | Easy Step | DIACHEX* PRO | |
| Hypoglycemic and | |||
| hyperglycemic alarm | 2 user setting alarms | none | 2 user setting alarms |
| Backlight | none | Selectable backlight on/off by user | |
| LCD Display | Image: DIACHEX INFINITY LCD Display | Increase pre/pro meal test result indicator | |
| Image: DIACHEX PRO LCD Display | |||
| Coding | Fixed code | Fixed code | Glucode chip |
| PC link mode | Enter PC link mode by setting meter | Automatically enter PC link mode when | |
| plugging in the USB cable | |||
| Memory mode | Press M button to read average and | ||
| 300 test result memories | Press M button to read 300 test result | ||
| memories, press S button to read | |||
| average results | |||
| Meter Appearance | Image: DIACHEX INFINITY Meter Appearance | Image: Easy Step Meter Appearance | Image: DIACHEX PRO Meter Appearance |
| Meter Size | 92 x 58 x 19 (mm) | 79 x 60 x 17 (mm) | 92 x 58 x 19 (mm) |
| Meter Weight | Appx. 60 grams | Appx. 55 grams | Appx. 60 grams |
Differences:
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8. PERFORMANCE CHARACTERISTIC SUMMARY
Within day precision test was performed with 5 levels of spiked whole blood each with one lot test strip. Samples were tested with 100 measurements obtained from 10 meters with each level of blood sample. Results are summarized below.
| Unit:mg/dL | YSI | AVG | Bias % | Std | CV % | |
|---|---|---|---|---|---|---|
| Proposed | ||||||
| Device | Easy Step | 43.8 | 42.6 | -2.8 | 2.47 | 5.80 |
| 87.8 | 85.1 | -3.1 | 2.92 | 3.43 | ||
| 132 | 135.7 | 2.8 | 4.65 | 3.42 | ||
| 206 | 209.2 | 1.5 | 4.98 | 2.38 | ||
| 320 | 323.4 | 1.0 | 6.72 | 2.08 | ||
| DIACHEX* | ||||||
| PRO | 45.6 | 45.3 | -0.6 | 2.30 | 5.08 | |
| 82.1 | 83.8 | 2.1 | 3.04 | 3.62 | ||
| 126 | 124.5 | -1.2 | 3.76 | 3.02 | ||
| 224 | 219.4 | -2.0 | 5.63 | 2.56 | ||
| 337 | 334.3 | -0.8 | 7.25 | 2.17 | ||
| Predicate | ||||||
| Device | DIACHEX* | |||||
| INFINITY | 39.7 | 40.7 | 2.6 | 2.22 | 5.45 | |
| 92.4 | 89.3 | -3.4 | 2.45 | |||
| 136 | 139.2 | 2.4 | 4.50 | |||
| 243 | 240.0 | -1.2 | 5.49 | |||
| 354 | 349.0 | -1.4 | 7.09 |
Linearity test was performed with 10 levels of spiked whole blood. Samples were tested with 10 measurements obtained from 10 meters with each level of blood sample using one lot test strip. The linear response range of proposed meter was defined from 20 to 600 mg/dL. and the actual studies were performed from ~25 to ~566 mg/dL. Linear regression results compared to YSI are summarized below.
| Device | Proposed Device | Predicate Device | |
|---|---|---|---|
| Easy Step | DIACHEX* PRO | DIACHEX* INFINITY | |
| Slope | 1.01 | 1.00 | 1.01 |
| Intercept | -1.11 | 0.41 | -0.23 |
| R2 | 0.9997 | 0.9996 | 0.9998 |
| sy.x | 5.45 | 6.66 | 6.77 |
To ensure that Easy Step, DIACHEX* PRO and DIACHEX* INFINITY system
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similarly, clinical accuracy was assessed in an in-house study performing by technician.129 participants both males and females ranged from age with sample ranged from 33.2 to 577mg/dL and hematocrit ranged from 34% to 53%. Values obtained from meters were compared to YSI results; linear results regression analysis yielded the following results:
| Fingertip | Proposed Devices | Predicate Device | |
|---|---|---|---|
| Easy Step | DIACHEX* PRO | DIACHEX* INFINITY | |
| N | 129 | 129 | 129 |
| Slope | 1.03 | 1.01 | 1.02 |
| Intercept | 2.18 | 3.10 | 1.44 |
| R2 | 0.9887 | 0.9890 | 0.9871 |
The alternate site testing was also been evaluated.
| Easy Step | Finger vs YSI | Palm vs YSI | Palm vs Finger | Forearm vs YSI | Forearm vs Finger |
|---|---|---|---|---|---|
| N | 113 | 113 | 113 | 113 | 113 |
| Slope | 1.03 | 1.01 | 0.98 | 1.01 | 0.97 |
| Intercept | 2.99 | 3.06 | 1.92 | 0.81 | 0.43 |
| R2 | 0.9797 | 0.9767 | 0.9871 | 0.9734 | 0.9753 |
| DIACHEX*
| PRO | Finger vs YSI | Palm vs YSI | Palm vs Finger | Forearm vs YSI | Forearm vs Finger |
|---|---|---|---|---|---|
| N | 113 | 113 | 113 | 113 | 113 |
| Slope | 1.02 | 1.01 | 0.99 | 1.03 | 1.00 |
| Intercept | 4.92 | 3.02 | 0.58 | -2.72 | -3.97 |
| R2 | 0.9815 | 0.9769 | 0.9856 | 0.9705 | 0.9659 |
| DIACHEX*
| INFINITY | Finger vs YSI | Palm vs YSI | Palm vs Finger | Forearm vs YSI | Forearm vs Finger |
|---|---|---|---|---|---|
| N | 113 | 113 | 113 | 113 | 113 |
| Slope | 1.02 | 1.02 | 0.98 | 1.02 | 0.99 |
| Intercept | 2.53 | -0.40 | -0.45 | -1.08 | -1.42 |
| R2 | 0.9770 | 0.9763 | 0.9739 | 0.9759 | 0.9766 |
The acceptable criteria is the ISO 15197 requirement of 95% of individual glucose results falling within ±15mg/dL at glucose concentration for samples Trade/Device Name: Easy Step/DIACHEX PRO Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: May 4, 2009 Received: May 5, 2009
Dear Dr. Tsai:
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).
JUN - 4 2009
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Page - 2
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 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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr.
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 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
At. H.
Courtney C. Harper, Ph.D. Acting 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
11090629 510(k) Number (if known):
Device Name: Easy Step / DIACHEX* PRO Blood Glucose Monitoring System
Indication for Use:
The Easy Step / DIACHEX PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro . diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.
Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (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 (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090629