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510(k) Data Aggregation
(141 days)
The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra®2, OneTouch®, UltraMini® and OneTouch®, UltraSmart® meters purchased before April 2016, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.
They are for single patient use only and should not be shared.
They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).
They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®, Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).
The UniStripl Generic Blood Glucose Test Strips are used with the OneTouch® Ultra, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters. The UniStrip1 Generic Blood Glucose Test Strips are intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The UniStrip1 Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch* Ultra* meter). The UniStrip1 Generic Blood Glucose Test Strips can only be used with the OneTouch® Ultra®, OneTouch Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016. UniStripl Generic Blood Glucose Test Strips are only for use with calibration code 49.
The provided text details various studies and their acceptance criteria for the UniStrip1™ Generic Blood Glucose Test Strips. This device is intended for self-testing of blood glucose with several OneTouch® Ultra® meters.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Study/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Altitude Study | Individual bias within ±10% at altitudes from 298 feet (91 meters) to 11,161 feet (3,402 meters). SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL. | Individual bias fell within ±10% from 298 feet (91 meters) to 11,161 feet (3,402 meters). SD < 5.0 mg/dL and CV < 5.0% for specified glucose concentrations. Claimed usability up to 10,000 ft. |
| Hematocrit Study | (1) All SD and CV < 5 mg/dL and 5% respectively. (2) All individual bias of glucose measurement vs YSI mean < 15%. (3) Mean Bias% to YSI for each sample < 10%. (4) Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. | (1) All SD and CV were less than 5 mg/dL and 5% respectively. (2) All individual bias of glucose measurement vs YSI mean was less than 15%. (3) Mean Bias% to YSI for each sample < 10%. (4) Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. Results met criteria for HCT 30% to 55%. |
| Interference Study | All bias of test results within the tested range ≤ 10% compared with controlled pool measurements. Concentration limits of interfering substances higher than therapeutic or physiological levels. | All bias of test results within the range were ≤ 10% compared with controlled pool. No obvious interference observed at therapeutic or physiological levels for interfering substances at two blood glucose levels. |
| Linearity Study | Correlation coefficient > 0.95. 100% of individual glucose results bias within ±10 mg/dL for glucose < 100 mg/dL, and ±10% for glucose ≥ 100 mg/dL, compared with YSI 2300. | Correlation coefficients were 0.9994 (Lot I), 0.99925 (Lot II), and 0.99955 (Lot III), all > 0.95. 100% of individual glucose results bias fell within ±10 mg/dL (glucose < 100 mg/dL) and ±10% (glucose ≥ 100 mg/dL) compared with YSI 2300. Linearity established from 20 to 600 mg/dL. |
| Operation Condition | Individual bias within ±10 mg/dL for glucose < 100 mg/dL and within ±10% for glucose ≥ 100 mg/dL. SD < 5.0 mg/dL for glucose < 100 mg/dL, and CV < 5.0% for glucose ≥ 100 mg/dL. | Individual bias was within ±10 mg/dL (glucose < 100 mg/dL) and within ±10% (glucose ≥ 100 mg/dL). SD < 5.0 mg/dL (glucose < 100 mg/dL) and CV < 5.0% (glucose ≥ 100 mg/dL). Operated normally in conditions 42-111°F (6-44°C), 10-90% R.H. |
| Precision Study | Pooled and maximum SD < 5.0 mg/dL for glucose < 75 mg/dL. Pooled and maximum CV < 5.0% for glucose ≥ 75 mg/dL. Maximum individual bias < 10% compared with glucose analyzer YSI 2300. | Pooled and maximum SD were < 5.0 mg/dL for glucose < 75 mg/dL. Pooled and maximum CV were < 5.0% for glucose ≥ 75 mg/dL. Maximum bias for all levels was between -5.3% and 3.7%. Repeatability CVs were primarily between 1.8% and 3.5%. Intermediate Precision CVs between 3.6% and 3.9%. |
| Shelf-Life Study | All data meet acceptance criteria. | Unopened vials stable for 24 months. Opened vials stable for 90 days. |
| User Performance | (Lay users): Correlation values R' > 0.98. Populations of individual bias: ≥95% users within ±15 mg/dL for glucose < 75 mg/dL, and ≥95% users within ±15% for glucose ≥ 75 mg/dL, compared with YSI 2300. | R' values were 0.9827 (Lot I), 0.9816 (Lot II), 0.9876 (Lot III), all > 0.98. For glucose < 75 mg/dL: 100% within ±15 mg/dL for fingertip and forearm. For glucose ≥ 75 mg/dL: 100% within ±15% for fingertip and forearm. |
| Satisfactory Evaluation | More than 85% of volunteers agree that labels and user guide provide enough product information. More than 95% of volunteers' scores > 80 points. | More than 85% of volunteers agreed labels and user guide provided enough information. More than 95% of scores were > 80 points. |
| Sample Volume Study | Required at least 1.0 µL to obtain normal test results. | The sample volume of UniStrip1 Generic Blood Glucose Test Strips with OneTouch® Ultra® Meters was required at least 1.0 µL to obtain the normal testing results. Measured glucose results using sample volumes from 1.0 to 1.5 µL. |
| Error Message Verification | Error messages displayed correctly at given conditions. | Error messages of OneTouch® Ultra® Meters displayed correctly at given condition of procedures. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Altitude Study: Not explicitly stated, but implies sufficient samples to demonstrate individual bias and precision metrics over the specified altitude range.
- Hematocrit Study: Not explicitly stated, but samples with HCT from 30% to 55% were used.
- Interference Study: Not explicitly stated, but samples with various interfering substances at different glucose levels were used.
- Linearity Study: Not explicitly stated, but implies sufficient samples to establish linearity across 20 to 600 mg/dL for three strip lots.
- Operation Condition Study: Not explicitly stated, but implies sufficient samples for evaluation in normal and extreme environments.
- Precision Study:
- Repeatability: 100 tests per lot at each of 5 glucose levels (Total: 3 lots x 5 levels x 100 tests = 1500 tests).
- Intermediate Precision: Not explicitly stated, but likely multiple tests per lot at each of 3 glucose levels over several days for each of 3 lots.
- Shelf-Life Study: Not explicitly stated.
- User Performance (Lay users) Evaluation:
- Glucose < 75 mg/dL: 20 capillary blood samples for fingertip, 20 for forearm.
- Glucose ≥ 75 mg/dL: 80 capillary blood samples for fingertip, 80 for forearm.
- Linearity Analysis: Implies sufficient samples collected by lay users to generate linearity equations for 3 strip lots.
- Satisfactory Evaluation: "More than 85% of volunteers" and "more than 95% of volunteers" imply a volunteer sample size, but the exact number isn't specified.
- Sample Volume Study: Not explicitly stated, but involved measuring glucose with sample volumes from 1.0 to 1.5 µL.
- Error Message Verification Study: Not explicitly stated.
Data Provenance: The studies were conducted by OK Biotech Co., Ltd. in Taiwan. The description does not specify if the data was retrospective or prospective, but clinical performance studies using human samples imply prospective collection for tests like user performance. Other tests (e.g., altitude, hematocrit, linearity, precision) likely used controlled laboratory samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document primarily refers to the YSI 2300 Glucose Analyzer as the reference method for establishing ground truth for glucose measurements. The YSI 2300 is a laboratory-grade analyzer, considered a gold standard for glucose measurement; therefore, specific human experts for ground truth adjudication are not typically used in this context.
4. Adjudication Method for the Test Set
- Adjudication in the traditional sense (e.g., 2+1 expert consensus) is not applicable here as the ground truth for glucose concentration is established by a reference laboratory instrument (YSI 2300). The device's performance is directly compared to the results from the YSI 2300.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
- No MRMC comparative effectiveness study was done. This device is a blood glucose test strip system, not an AI-assisted diagnostic imaging device or similar system where human reader performance would be a primary endpoint. The "User Performance" study evaluates lay users' ability to operate the device correctly and obtain accurate readings, which is a different type of assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is a standalone device in the sense that the test strip and meter system provide a direct glucose reading. There isn't an "algorithm only" component separate from the integrated device. The performance data presented (linearity, precision, interference, etc.) represent the standalone performance of the test strip system. The "User Performance" study specifically assesses human-in-the-loop performance by lay users but is focused on correct operation and result accuracy, not on assistance with an AI algorithm.
7. The Type of Ground Truth Used
- The primary ground truth used is reference measurement by a Glucose Analyzer, specifically the YSI 2300. This is considered a highly accurate laboratory method for quantitative glucose determination.
8. The Sample Size for the Training Set
- The document describes performance studies and evaluation against established methods (YSI 2300).
- No explicit training set or development set size is mentioned. This type of medical device (blood glucose test strips) typically undergoes analytical and clinical validation studies without a "training set" in the machine learning sense. The device's chemical and electrical components are designed and optimized, and then validated through these performance studies.
9. How the Ground Truth for the Training Set Was Established
- Since no explicit training set for a machine learning model is mentioned, the concept of establishing ground truth for a training set in that context does not apply directly. The "ground truth" for evaluating the performance of the device design and manufacturing process is consistently the YSI 2300 Glucose Analyzer, as mentioned above.
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(204 days)
The UniStrip1™ Generic Blood Glucose Test Strips are used with the OneTouch® Ultra@2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016, and OneTouch® Ultra® purchased before October 2012, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The strips are meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control.
They are for single patient use only and should not be shared.
They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use).
They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The UniStrip1™ Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch® Ultra® meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).
The UniStrip™ Control Solutions are for use with the UniStrip1™ Generic Blood Glucose Test Strips and OneTouch® Ultra® meters to check that the meters and test strip are working together properly and that the test is performing correctly.
UniStrip1 Generic Blood Glucose Test Strips are used with the OneTouch® Ultra, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters. The test strips are intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. UniStrip1 Generic Blood Glucose Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch* Ultra* meter). UniStrip1 Generic Blood Glucose Test Strips can only be used with the OneTouch® Ultra®2, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before April 2016, and OneTouch® Ultra® purchased before October 2012. UniStrip1 Generic Blood Glucose Test Strips are only for use with calibration code 49.
The document provided describes the UniStrip1 Generic Blood Glucose Test Strips and the studies conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several tests conducted according to ISO 15197:2013 and other CLSI/NCCLS standards. The acceptance criteria are generally qualitative (e.g., "met acceptance criteria," "within ±10 mg/dL," "less than 5.0 %"). For the User Performance Evaluation, a specific quantitative acceptance criterion is provided.
| Test / Performance Metric | Acceptance Criteria (as stated in document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Sample Volume | Glucose measurements meet acceptance criteria. Required sample volume at least 1.0 µL to obtain normal testing results. | Glucose measurements of sample volume from 1.0 to 1.5 µL met acceptance criteria for normal testing results. |
| Operation Condition | Individual bias within ±10 mg/dL at glucose < 75 mg/dL and within ±10% at glucose ≥ 75 mg/dL. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. | Individual bias within ±10 mg/dL at glucose < 75 mg/dL. Individual bias within +10% at glucose ≥ 75 mg/dL. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Operated normally in conditions 42-111 °F (6-44°C), 10-90% R.H. |
| Hematocrit Study | 1. All SD and CV < 5 mg/dL and 5%, respectively. 2. All individual bias vs. YSI mean < 15%. 3. Mean Bias% to YSI for each sample at each Hct level < 10%. 4. Difference % between mean glucose bias and mean bias of mid-level sample (Hct: 42%) < 10%. Test results met acceptance criteria. Hematocrit range from 30% to 55% available. | Met all four acceptance criteria. HCT ranges from 30% to 55% are available. |
| Altitude Study | Individual bias within ±10%. SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Test results met acceptance criteria. No significant effects from various altitudes. | Individual bias within ±10% at altitude from 298ft (91m) to 11,161ft (3,402m). SD < 5.0 mg/dL at glucose < 75 mg/dL. CV < 5.0% at glucose ≥ 75 mg/dL. Claims use up to 10,000 ft. |
| Linearity Study | R² > 0.95. 100% of individual glucose results within ±10 mg/dL at glucose < 75 mg/dL, and within ±10% at glucose > 75 mg/dL compared with Glucose Analyzer YSI 2300. Test results met acceptance criteria. Linearity available from 20 to 600 mg/dL. | Reported R² values for all meters and test sites are > 0.98 (ranging from 0.9829 to 0.9884), exceeding the >0.95 criterion. 100% of bias fell within ±10 mg/dL (<75 mg/dL) and ±10% (>75mg/dL) compared to YSI 2300. Linearity available from 20 to 600 mg/dL. |
| Precision Study | Pooled and maximum SD < 5.0 mg/dL at glucose < 75 mg/dL. Pooled and maximum CV < 5.0% at glucose ≥ 75 mg/dL. Maximum individual bias < 10% compared with glucose analyzer YSI 2300. Test results met acceptance criteria. | Within Run: SDs ranged from 1.2 to 8.2 mg/dL; CVs ranged from 1.5% to 3.5%. Between Run: SDs ranged from 0.8 to 8.0; CVs ranged from 2.1% to 3.1%. All stated to meet acceptance criteria for repeatability and intermediate precision. Maximum individual bias within 10% compared to YSI 2300. |
| Interference Study | All bias of test results for interfering substances within the range listed were < 10% compared with controlled pool measurements. No obvious interference observed at therapeutic or physiological levels. | All bias of test results within the listed range were < 10% compared with measurements of the controlled pool. No obvious interference observed in interfering substances at therapeutic nor physiological levels. |
| Shelf-Life Study | All data met acceptance criteria. Expected closed vial stability of 24 months, in-use vials 90 days for strips. Expected closed and in-use vial stability of 18 months and 90 days respectively for control solutions. | All data met the acceptance criteria. Closed vials of UniStrip1 Generic Blood Glucose Test Strips stable for 24 months, and 90 days for in-use vials. Closed and in-use vials of UniStrip Control Solutions stable for 18 months and 90 days respectively. |
| User Performance | Populations of individual bias ± 15 mg/dL at blood glucose concentration < 75 mg/dL and ± 15 % at blood glucose concentration ≥ 75 mg/dL compared with Glucose Analyzer YSI 2300 are more than 95 %. Test results met acceptance criteria, demonstrating proper operation by lay users. | The test results show that the populations of individual bias ± 15 mg/dL at blood glucose concentration < 75 mg/dL and ± 15 % at blood glucose concentration ≥ 75 mg/dL compared with Glucose Analyzer YSI 2300 are more than 95 %. |
| Satisfactory Evaluation | More than 85% of volunteers agree labels/user guide provide enough info. More than 95% of volunteers' scores > 80 points. | More than 85% of volunteers agree that the labels on the packing and the users' guide provided enough information. More than 95% of volunteers' scores were higher than 80 points. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Volume Study: Not explicitly stated, but "sample volume from 1.0 to 1.5 µL" was tested.
- Operation Condition Study: Not explicitly stated.
- Hematocrit Study: Not explicitly stated.
- Altitude Study: Not explicitly stated.
- Linearity Study: Not explicitly stated for each test point, but the method NCCLS/CLSI EP6-A:2014 suggests multiple readings across the range.
- Precision Study (Repeatability): For each of the 3 meters (OneTouch Ultra2, UltraMini, UltraSmart), 3 lots were tested, with 5 different glucose concentrations. For each concentration/lot/meter combination, n=50 measurements were taken. (e.g., 3 meters * 3 lots * 5 concentrations * 50 measurements = 2250 total measurements for repeatability study).
- Precision Study (Intermediate Precision): 3 lots were tested with 3 different glucose concentrations. Sample size not explicitly stated for each condition, but likely drawn from the broader precision study data.
- Interference Study: Not explicitly stated.
- Shelf-Life Study: Not explicitly stated.
- User Performance Evaluation: Not explicitly stated for the number of lay users.
- Satisfactory Evaluation: Not explicitly stated for the number of volunteers.
Data Provenance: The studies were conducted by OK BIOTECH CO., LTD. (Taiwan). The document does not specify the country of origin of the human blood samples used in the studies (e.g., for hematocrit, user performance). The studies are "pre-clinical data," implying they were conducted prospectively for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No information is provided regarding the number of experts used or their qualifications for establishing ground truth for any of the studies.
- The ground truth reference method explicitly mentioned is the Glucose Analyzer YSI 2300. This is a laboratory reference instrument, not a human expert.
4. Adjudication Method for the Test Set
- No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied as the ground truth is established by a laboratory instrument (YSI 2300) rather than human interpretation that would typically require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is a blood glucose test strip system, which provides a quantitative measurement, and does not involve human "readers" in the diagnostic interpretation sense that an AI-assisted imaging device would. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device (test strip + meter) is inherently a standalone system in terms of generating a glucose reading. The User Performance Evaluation evaluates the ability of lay users to operate the system correctly and obtain accurate results, which is a human-in-the-loop operational assessment, but the performance of the device itself in producing the glucose value is "standalone" from a diagnostic interpretation perspective. The closest comparison would be the linearity and precision studies that demonstrate the device's accuracy against a lab reference, which is essentially a standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for quantitative glucose measurements in several studies (Linearity, Precision, Hematocrit, User Performance) was established using a Glucose Analyzer YSI 2300. This is a laboratory reference instrument for measuring glucose concentration.
8. The Sample Size for the Training Set
- No information is provided about a specific "training set" or its size. This type of medical device (blood glucose test strip) does not typically involve machine learning or AI models that require distinct training sets in the same manner as image analysis algorithms. The device's performance is characterized through direct analytical and clinical studies.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned or implied for this type of device, this question is not applicable.
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