DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
Device Facts
| Record ID | K073492 |
|---|---|
| Device Name | DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM |
| Applicant | Tyson Bioresearch, Inc. |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Apr 8, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The DIACHEX* DETERMINE / DIACHEX* INFINITY 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 DIACHEX DETERMINE / DIACHEX INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX* DETERMINE / DIACHEX* INFINITY 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.
Device Story
System measures glucose in capillary whole blood (fingertip, palm, forearm) via electrochemical biosensor (glucose oxidase). User applies 0.5 uL sample to test strip; meter measures electrical current proportional to glucose concentration. DETERMINE model uses Glucode chip for strip coding; INFINITY model uses factory-programmed fixed code. Systems include meter, test strips, control solutions, and lancing device. Used at home (OTC) or in clinical settings. Data can be downloaded to PC via RS232 port. Provides quantitative glucose results to aid diabetes management. Alternative site testing restricted to steady-state conditions.
Clinical Evidence
Clinical accuracy evaluated in 112 lay users and 124 technician-performed tests across 2 clinical sites and 1 OTC site. Samples ranged 33-581 mg/dL. Fingertip, palm, and forearm testing compared against YSI-2300 reference. Results showed 97.3%-100% of samples met ISO 15197 requirements (±15mg/dL for <75mg/dL; ±20% for ≥75mg/dL). Bench testing included precision (CV% 1.65-4.78%), linearity (R² >0.999), hematocrit effect (29-59%), altitude (up to 7545 ft), and interference testing for 18 substances.
Technological Characteristics
Electrochemical biosensor using glucose oxidase. Measuring range 20-600 mg/dL. Sample volume 0.5 uL. Connectivity via RS232 for PC data download. DETERMINE model uses Glucode chip; INFINITY model uses factory-programmed fixed code. Complies with ISO 15197.
Indications for Use
Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Intended for home (OTC) use by persons with diabetes or in clinical settings by healthcare professionals to monitor diabetes control. Not for diagnosis or screening of diabetes mellitus. Not for neonatal testing. Alternative site testing only during steady-state blood glucose conditions.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- DIACHEX Blood Glucose Monitoring System (k062829)
Related Devices
- K072441 — EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM · Tyson Bioresearch, Inc. · Mar 25, 2008
Submission Summary (Full Text)
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# 510(k) SUMMARY
#### 1. DATE PREPARED
December 12, 2007
#### 2. SPONSOR INFORMATION
Address
TYSON BIORESEARCH, INC. 5 F., # 22, KE TUNG RD., 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: | DIACHEX* DETERMINE Blood Glucose Monitoring System<br>DIACHEX* INFINITY Blood Glucose Monitoring System |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Common Names/Descriptions: | Blood Glucose Monitoring System |
| Classification Names: | Glucose test system, product code 75CGA<br>and "System, test, blood glucose, over the counter", product code 75NBW. 21 CFR 862.1345 |
### 4. DEVICE DESCRIPTION:
The DIACHEX* DETERMINE / DIACHEX* INFINITY 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. DIACHEX* DETERMINE / DIACHEX* INFINITY provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.
The DIACHEX* DETERMINE / DIACHEX* INFINITY 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 DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose
K073492
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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 10 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 DIACHEX* DETERMINE / DIACHEX* INFINITY 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 DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX* DETERMINE / DIACHEX* INFINITY 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.
## 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 Blood Glucose Monitoring System
Predicate 510(k) number(s): k062829
Comparison with predicate:
This 510(K) amendment addresses the modification of the DIACHEX Blood Glucose
073
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Monitoring System previously cleared under K062829 and addition of alternate site testing sites for the glucose testing portion.
The modifications encompass the sample volume, reaction time, operating principle, meter software, LCD display and addition of alternate site testing sites (the palm and the forearm) for the glucose testing portion. The DIACHEX* Blood Glucose Monitoring System includes two models, DIACHEX* DETERMINE and DIACHEX* INFINITY. The differences between these two models are the strip ejector function. coding method, LCD display, strip width and meter outside looking. The strip of the DIACHEX* INFINITY system can be removed by pushing strip eject button and also can be removed by hand. The DIACHEX* INFINITY system eliminate the need for manual coding of the test strips by the user by assigning codes when manufactured. Except these, all main meter internal electronic components, meter functions and detection algorithm of these two models are exactly the same. The deference between DIACHEX DETERMINE and DIACHEX INFINITY from DIACHEX system is outline below.
| | Predicate Device | Proposed Device | |
|-----------------------------------------|----------------------|--------------------------------------------------------|-----------------------------------------------------------------|
| Item | DIACHEX<br>(K062829) | DIACHEX*<br>DETERMINE | DIACHEX*<br>INFINITY |
| Blood Sample | Fingertip | Fingertip, Palm and Forearm | Fingertip, Palm and Forearm |
| Sample Volume | 1.5uL | 0.5uL | 0.5uL |
| Test Time | 10 seconds | 5 seconds | 5 seconds |
| Reminder alarm | not present | 4 user setting alarms | 4 user setting alarms |
| Hypoglycemic and<br>hyperglycemic alarm | not present | 2 user setting alarms | 2 user setting alarms |
| LCD Display | ----- | Increase alarm, strip, code and control solution icons | Increase alarm, strip eject indicate and control solution icons |
| Average result | 14 Days | 7,14 and 30 Days | 7,14 and 30 Days |
| Coding | Glucode Chip | Glucode Chip | No coding required<br>(assign code when manufactured) |
| PC download option | not present | RS232 | RS232 |
## Differences:
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| Shape of the electrode<br>on the test strip | Image: electrode shape | Image: electrode shape | Image: electrode shape |
|---------------------------------------------|------------------------|------------------------|------------------------|
| Strip Eject Button | not present | not present | One eject button |
| Meter Size | 102 x 52 x 17 (mm) | 102 x 52 x 17 (mm) | 92 x 58 x 19 (mm) |
| Meter Weight | Appx. 55 grams | Appx. 55 grams | Appx. 60 grams |
| Meter Connector width | 5.2 mm | 5.2 mm | 7.2 mm |
# Similarities:
| Item | Predicate Device | Proposed Device |
|------------------------------|----------------------------------------------------|-----------------------------------------|
| | DIACHEX (K062829) | DIACHEX* DETERMINE<br>DIACHEX* INFINITY |
| Test Principle | Electrochemical biosensor with<br>glucose oxidase. | identical |
| Detecting Range | 20 ~ 600 mg/dL | identical |
| Unit of measurement | mg/dL or mmol/L | identical |
| HCT Range | 35 ~55 % | identical |
| Control Solution | 3 Levels available | identical |
| Operating Temperature | 10 to 40 °C (50-104°F) | identical |
| Operating Humidity | 10 to 90% | identical |
| Memory capacity | 300 Test Results | identical |
| Strip Storage<br>Temperature | 4 to 30 °C (40-86°F) | identical |
| Battery Power | One 3 V Lithium CR 2032<br>battery | identical |
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## 8. PERFORMANCE CHARACTERISTIC SUMMARY
Day to day precision of the DIACHEX* system was performed with 3 levels of glucose control solutions each with 3 different lots test strips. Samples were tested with 10 measurements obtained from 10 meters with each level of control solution over 10 days. Within day precision test was performed with 5 levels of spiked whole blood. Samples were test with 10 measurements obtained from 10 meters with each level of blood sample using 3 different lots test strips. Results are summarized below.
| Day to Day precision result | |
|-----------------------------|--|
|-----------------------------|--|
| Device | | Level 1 | Level 2 | Level 3 |
|------------------------|------|---------|---------|---------|
| DIACHEX +<br>DETERMINE | MEAN | 38.6 | 111.4 | 401.8 |
| | SD | 1.81 | 3.05 | 6.87 |
| | CV% | 4.69 | 2.74 | 1.71 |
| DIACHEX+<br>INFINITY | MEAN | 37.7 | 109.4 | 401.3 |
| | SD | 1.77 | 2.86 | 6.64 |
| | CV% | 4.68 | 2.62 | 1.65 |
3 lot average results. 10 Tests of each level of each lot for 10 days.
#### Within Day precision result
| Device | YSI | AVG | Bias % | Std | CV |
|------------------------|------|-----|--------|------|------|
| | 37.7 | 39 | 4.22 | 1.83 | 4.66 |
| DIACHEX +<br>DETERMINE | 90.0 | 89 | -1.33 | 2.82 | 3.19 |
| | 130 | 125 | -3.67 | 4.10 | 3.29 |
| | 224 | 221 | -1.26 | 5.38 | 2.44 |
| | 353 | 359 | 1.78 | 7.56 | 2.11 |
| | 40.4 | 40 | -2.29 | 1.89 | 4.78 |
| DIACHEX+<br>INFINITY | 85.8 | 85 | -1.42 | 2.83 | 3.35 |
| | 129 | 128 | -0.95 | 4.03 | 3.15 |
| | 223 | 221 | -0.98 | 5.64 | 2.56 |
| | 357 | 358 | 0.16 | 7.51 | 2.10 |
3 lot average results. 100 Tests of each level of each lot.
To establish the linearity of the DIACHEX* system whole blood samples were compared to YSI 2300 with 3 lots of test strips using 10 different glucose concentrations. For each lot of test strips, 10meters were tested for each concentration. Linear regression yields the following result. The operating range of 076 the meter is 20-600mg/dL.
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| | DIACHEX* DETERMINE | | | DIACHEX* INFINITY | | |
|-----------|--------------------|--------|--------|-------------------|--------|--------|
| | LOT 1 | LOT 2 | LOT 3 | LOT 1 | LOT 2 | LOT 3 |
| Slope | 1.02 | 1.00 | 1.02 | 1.01 | 1.00 | 1.01 |
| Intercept | -3.31 | -2.24 | -1.37 | -1.79 | -1.23 | -1.51 |
| R2 | 0.9996 | 0.9997 | 0.9997 | 0.9999 | 0.9997 | 0.9997 |
The hematocrit effect of the DIACHEX* system was evaluated of hematocrit levels 29%-59% on whole blood samples spiked with 11 hematocrit levels for 4 glucose values (44-372mg/dL). The test results were compared with the glucose values from YSI 2300. The acceptable criteria of bias was ± 10mg/dL when glucose concentration was < 75mg/dL and ± 10% for glucose concentration ≥ 75mg/dL.The result is summarized below.
| YSI HT | | | Slope | Intercept | R2 |
|----------|------|------|--------|-----------|----|
| 29% | 1.15 | 2.1 | 0.9998 | | |
| 32% | 1.12 | -2.0 | 0.9992 | | |
| 35% | 1.08 | -1.6 | 0.9999 | | |
| 38% | 1.07 | -3.9 | 1.0000 | | |
| 41% | 1.04 | -1.2 | 1.0000 | | |
| 44% | 0.98 | 3.4 | 1.0000 | | |
| 47% | 0.97 | 2.1 | 0.9998 | | |
| 50% | 0.96 | 2.3 | 1.0000 | | |
| 53% | 0.93 | 1.4 | 0.9993 | | |
| 56% | 0.92 | 0.6 | 0.9998 | | |
| 59% | 0.83 | 3.7 | 0.9987 | | |
Altitude study was performed with capillary whole blood samples from 20 volunteers and 5 levels spiked venous blood samples. All the results show that Bias% result is within the acceptable criteria ( ±10mg/dL when glucose concentration was < 75mg/dL and ± 15% for glucose concentration ≥ 75mg/dL ) at altitude up to 7545 feet.
Interference was studied of the following substances with 2 levels spiked venous blood. No interference was identified as having a percent bias ≤ 10%.
| Interferent | Therapeutic Test<br>Level (mg/dL) | High Test Level<br>(mg/dL) | No Interference<br>Level (mg/dL) |
|---------------|-----------------------------------|----------------------------|----------------------------------|
| Acetaminophen | 2 | 4 | 3 |
| Ascorbic acid | 2 | 15 | 7.5 |
| Bilirubin | 1.2 | 20 | 20 |
| Cholesterol | 30 | 500 | 375 |
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| Creatinine | 1.5 | 30 | 30 |
|-----------------|-----|------|------|
| EDTA | --- | 4 | 4 |
| Galactose | --- | 20 | 20 |
| Glycerol | --- | 9.21 | 9.21 |
| Heparin | --- | 60 | 60 |
| Ibuprofen | 4.2 | 40 | 40 |
| L-Dopa | 0.3 | 2 | 1 |
| Maltose | --- | 40 | 40 |
| Salicylate | 30 | 125 | 125 |
| Sodium Fluoride | --- | 500 | 500 |
| Tetracycline | 0.4 | 4 | 4 |
| Tolazamide | 2.5 | 5 | 3.75 |
| Tolbutamide | 10 | 100 | 100 |
| Triglyceride | 190 | 2000 | 2000 |
| Uric acid | 7.7 | 20 | 15 |
# Clinical Accuracy of the DIACHEX* Blood Glucose Monitoring System
To ensure that these meters perform similarly, DIACHEX(predicate device), DIACHEX* DETERMINE and DIACHEX* INFINITY meters were compared against standard YSI-2300 by testing from the fingertip. The test was assessed in an in-house study performing by technician. 118 participants both males ranged from age. The samples ranged from 25.4 to 571mg/dL and hematocrit ranged from 34% to 51%.
Values obtained from meters were compared to YSI results; linear results regression analysis yielded the following results:
| Fingertip | Predicate Device | Proposed Devices | |
|-----------|------------------|--------------------|-------------------|
| | DIACHEX | DIACHEX+ DETERMINE | DIACHEX+ INFINITY |
| N | 118 | 118 | 118 |
| Slope | 0.98 | 0.98 | 0.98 |
| Intercept | 0.62 | -0.32 | 1.31 |
| R2 | 0.9843 | 0.9867 | 0.9879 |
The samples that met the ISO 15197 requirement were summarized below.
| Device | DIACHEX | DETERMINE | INFINITY |
|--------------------|-------------|-------------|-------------|
| Percentage met ISO | 98.3% | 99.2% | 99.2% |
| requirement | (116 / 118) | (117 / 118) | (117 / 118) |
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Clinical Accuracy of the DIACHEX* system was performed with a total of 112 lay users and 12 contrived samples (That were 33 to 48mg/dL and 462 to 581mg/dL) at 2 clinical sites and one OTC site. Participants ranged from age, education and consisted of 41% males and 59% females with sample range 33~581mg/dL and hematocrit range 33%~54%. The performance of alternate site testing (AST) of systems were also been evaluated. The test results of capillary blood obtained from fingertip was compared to the results obtained from palm and forearm. Values obtained from meters were compared to YSI results; linear result regression analysis yielded the following results.
| Finger | Lay User vs YSI | Technician vs YSI | Lay User vs Technician |
|-----------|-----------------|-------------------|------------------------|
| N | 112 | 124 | 112 |
| Slope | 0.98 | 0.97 | 1.00 |
| Intercept | -0.52 | 1.31 | -0.62 |
| R2 | 0.9789 | 0.9872 | 0.9900 |
The regression of AST test results was shown as below:
| Lay User | Finger vs YSI | Palm vs YSI | Palm vs Finger | Forearm vs YSI | Forearm vs Finger |
|-----------|---------------|-------------|----------------|----------------|-------------------|
| N | 112 | 111 | 111 | 111 | 111 |
| Slope | 0.98 | 0.96 | 0.97 | 0.95 | 0.96 |
| Intercept | -0.52 | 1.77 | 3.12 | 2.34 | 3.54 |
| R2 | 0.9789 | 0.9796 | 0.9861 | 0.9745 | 0.9825 |
The acceptable criteria is the ISO 15197 requirement of 95% of individual glucose results falling within ±15mg/dL at glucose concentration for samples <75mg/dL and within ±20% at glucose concentrations≥75mg/dL. The samples that met the ISO 15197 requirement were summarized in the table below.
| Operator | Technician | Lay user | | |
|-----------------------------------|------------|-------------|-------------|-------------|
| Site | Finger | Finger | Palm | Forearm |
| N | 124 | 112 | 111 | 111 |
| Percentage met ISO<br>requirement | 100.0% | 98.2% | 99.1% | 97.30% |
| | (124/ 124) | (110 / 112) | (110 / 111) | (108 / 111) |
From the above it is concluded that the results obtained from the alternate site sampling using DIACHEX* DETERMINE system, are similar to those obtained from finger stick whole blood with no effect on clinical action.
From the above test results, we conclude that the modification of the DIACHEX Meter
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do not affect the effectiveness and safety of the device. The proposed device (DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System) is substantial equivalent to the original cleared device. The results of clinical alternate site testing demonstrate that the results obtained from the alternate site sampling are similar to those obtained from finger stick whole blood with no effect on clinical action. DIACHEX* DETERMINE / DIACHEX* INFINITY system provides the users an option to use the palm and the forearm in addition to the fingertip to collect capillary blood for self monitoring of blood glucose within certain conditions as explained in product user's manual. DIACHEX* DETERMINE / DIACHEX* INFINITY are suitable for its intended use. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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Image /page/9/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design resembling an eagle or bird-like figure, with stylized lines forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central emblem.
MAY 29 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tyson Bioresearch, Inc. c/o Mr. Simon Tsai (Wen-Hai Tsai) 5F, #22, Ke E. Road III Science-Based Industrial Park Chu-Nan, Taiwan Republic of China. Postal Code: 350
Re: k073492
Trade Name: Diachex+ Determine Blood Glucose Monitoring System Diachex+ Infinity Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: March 10, 2008 Received: March 11, 2008
Dear Mr. Tsai:
This letter corrects our substantial equivalent letter of April 8, 2008.
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. Iisting 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).
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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 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
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# Indication for Use
KO73492 510(k) Number (if known):
DIACHEX* DETERMINE / DIACHEX* INFINITY Device Name: Blood Glucose Monitoring System
Indication For Use:
The DIACHEX* DETERMINE / DIACHEX* INFINITY 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 DIACHEX DETERMINE / DIACHEX INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX* DETERMINE / DIACHEX* INFINITY 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)
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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k073492
