(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 0.95. 100% of individual glucose results within ±10 mg/dL 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 (75mg/dL) compared to YSI 2300. Linearity available from 20 to 600 mg/dL. |
| Precision Study | Pooled and maximum SD 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.
§ 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.