(118 days)
Not Found
No
The document describes a standard amperometric biosensor for glucose measurement and does not mention any AI or ML components. The performance studies focus on traditional analytical and clinical accuracy metrics.
No.
Explanation: The device is an "in vitro diagnostic use" system that measures glucose levels and aids in monitoring the effectiveness of diabetes control. It is explicitly stated that "It is not intended for the diagnosis of or screening for diabetes mellitus." It does not provide treatment or directly affect the body's function, making it a diagnostic tool rather than a therapeutic one.
No
The text explicitly states: "It is not intended for the diagnosis of or screening for diabetes mellitus."
No
The device description explicitly mentions a "Blood Glucose Monitoring System" which includes an "amperometric biosensor" and "test strips." These are hardware components necessary for the device's function of measuring glucose in blood. The software likely processes the data from these hardware components, but the system as a whole is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use)."
- Nature of the Test: The device measures glucose in fresh capillary whole blood. This is a test performed on a biological sample taken from the body, which is a key characteristic of an in vitro diagnostic test.
- Purpose: The system is intended as an aid in monitoring the effectiveness of diabetes control. This is a diagnostic purpose, even though it's not for initial diagnosis or screening.
The information provided clearly indicates that this device is designed to perform diagnostic testing on a sample outside of the body.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
75CGA, 75NBW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm
Indicated Patient Age Range
It is not intended for neonatal testing.
Intended User / Care Setting
intended for use at 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristic Summary:
Day to day precision was performed with 3 levels of glucose control solutions with 3 different lots of test strips. Samples were tested with 10 measurements from 10 meters for each level over 10 days.
Within day precision test was performed with 5 levels of spiked whole blood. Samples were tested with 10 measurements from 10 meters using 3 different lots of test strips.
Linearity: Whole blood samples were compared to YSI 2300 with 3 lots of test strips using 10 different glucose concentrations. For each lot, 10 meters were tested for each concentration.
Hematocrit effect was evaluated for levels 29%-59% on whole blood samples spiked with 11 hematocrit levels for 4 glucose values (44-372mg/dL).
Altitude study was performed with capillary whole blood samples from 20 volunteers and 5 levels spiked venous blood samples.
Interference with various substances was studied with 2 levels spiked venous blood.
Clinical Accuracy:
An in-house study compared DIACHEX (predicate), DIACHEX* DETERMINE, and DIACHEX* INFINITY meters against YSI-2300 using fingertip samples.
Sample Size: 118 participants (males ranged from age, samples from 25.4 to 571mg/dL, hematocrit from 34% to 51%).
Results:
Fingertip (118 participants):
Predicate Device (DIACHEX): Slope 0.98, Intercept 0.62, R2 0.9843, 98.3% met ISO requirement (116/118)
Proposed Devices (DIACHEX+ DETERMINE): Slope 0.98, Intercept -0.32, R2 0.9867, 99.2% met ISO requirement (117/118)
Proposed Devices (DIACHEX+ INFINITY): Slope 0.98, Intercept 1.31, R2 0.9879, 99.2% met ISO requirement (117/118)
Clinical Accuracy with lay users and alternate site testing (AST):
Study with 112 lay users and 12 contrived samples (33 to 48mg/dL and 462 to 581mg/dL) at 2 clinical sites and one OTC site.
Participants: ranged from age, education, 41% males, 59% females, sample range 33~581mg/dL, hematocrit range 33%~54%.
Comparison between capillary blood from fingertip, palm, and forearm to YSI results.
Regression results for Lay User:
Finger vs YSI (N=112): Slope 0.98, Intercept -0.52, R2 0.9789
Technician vs YSI (N=124): Slope 0.97, Intercept 1.31, R2 0.9872
Lay User vs Technician (N=112): Slope 1.00, Intercept -0.62, R2 0.9900
Regression results for AST (Lay User):
Finger vs YSI (N=112): Slope 0.98, Intercept -0.52, R2 0.9789
Palm vs YSI (N=111): Slope 0.96, Intercept 1.77, R2 0.9796
Palm vs Finger (N=111): Slope 0.97, Intercept 3.12, R2 0.9861
Forearm vs YSI (N=111): Slope 0.95, Intercept 2.34, R2 0.9745
Forearm vs Finger (N=111): Slope 0.96, Intercept 3.54, R2 0.9825
ISO 15197 requirement met (within ±15mg/dL for
§ 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
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
DIACHEX* INFINITY 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 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
1
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 | ||
| (K062829) | DIACHEX* | ||
| DETERMINE | DIACHEX* | ||
| 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 | |||
| 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 |
| (assign code when manufactured) | |||
| PC download option | not present | RS232 | RS232 |
Differences:
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| Shape of the electrode
| 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 | |
| DIACHEX* INFINITY | ||
| Test Principle | Electrochemical biosensor with | |
| 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 | ||
| Temperature | 4 to 30 °C (40-86°F) | identical |
| Battery Power | One 3 V Lithium CR 2032 | |
| 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 + | ||||
| DETERMINE | MEAN | 38.6 | 111.4 | 401.8 |
| SD | 1.81 | 3.05 | 6.87 | |
| CV% | 4.69 | 2.74 | 1.71 | |
| DIACHEX+ | ||||
| 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 + | |||||
| 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+ | |||||
| 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