(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 0.95. 100% of individual glucose results bias within ±10 mg/dL for glucose 0.95. 100% of individual glucose results bias fell within ±10 mg/dL (glucose 0.98. Populations of individual bias: ≥95% users within ±15 mg/dL for glucose 0.98. For glucose 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
§ 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.