(71 days)
No
The device description details a standard electrochemical biosensor technology for glucose measurement, which does not involve AI or ML. The performance studies focus on correlation with reference methods, not on training or testing of AI/ML models.
No
The device is an in vitro diagnostic (IVD) test strip intended for the quantitative measurement of glucose, which is used for diagnostic purposes rather than for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test strips are "intended for in vitro diagnostic use" for the quantitative measurement of glucose in blood.
No
The device description clearly states it is a "Blood Glucose Test Strip" which is a physical, consumable component used with a sensor. It describes the physical process of applying blood to the strip and the electrochemical reaction that occurs. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Precision QID Blood Glucose Test Strips are intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood."
This statement directly identifies the device as being for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Precision QID Blood Glucose Test Strips are intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.
Product codes
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Device Description
The Precision QID Blood Glucose Test Strip utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. Insertion of a test strip into the sensor, automatically turns the sensor on. A drop of whole blood or control solution is applied to the target area of the test strip and the assay is automatically initiated. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the Precision QID Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 20 seconds. Because the Precision QID Blood Glucose Test Strip is an evolutionary offspring of the MediSense Pen 2 / Companion 2 Blood Glucose Test Strip, the Precision QID Blood Glucose Test Strip is fully compatible with the Pen 2/ Companion 2 Test System (K901613), the Satellite G Test System (K891695) which has been renamed to Precision G, The MediSense 2 Pen and Card System (K944195), and the Precision QID Test System (K944195).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For home or professional use / Not Found
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
Not Found
Summary of Performance Studies
Clinical testing using arterial whole blood was performed at a university medical center by comparison of patient results obtained with the Precision OID Blood Glucose Testing System to results obtained with both a whole blood and a plasma hexokinase reference method. Results for both reference methods are summarized below. In addition, results obtained with the predicate Precision QID Blood Glucose Test Strip using capillary whole blood as compared to a whole blood reference method are included.
Key Metrics
- Correlation Coefficient (r): 0.961 (Arterial Whole Blood* - Arterial Whole Blood), 0.967 (Arterial Whole Blood* - Arterial Plasma), 0.984 (Capillary Whole Blood** - Capillary Whole Blood)
- Slope (m): 1.005 (Arterial Whole Blood* - Arterial Whole Blood), 0.971 (Arterial Whole Blood* - Arterial Plasma), 0.938 (Capillary Whole Blood** - Capillary Whole Blood)
- Y-intercept, mg/dL: -6.2 (Arterial Whole Blood* - Arterial Whole Blood), 0.7 (Arterial Whole Blood* - Arterial Plasma), 10.6 (Capillary Whole Blood** - Capillary Whole Blood)
- N: 320 (Arterial Whole Blood* - Arterial Whole Blood), 306 (Arterial Whole Blood* - Arterial Plasma), 311 (Capillary Whole Blood** - Capillary Whole Blood)
Predicate Device(s)
Precision QID™ Blood Glucose Test Strip - K945887, Accu-Chek Advantage Test Strips - K951887
Reference Device(s)
K901613, K891695, K944195, K944195
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Summary of Safety and Effectiveness
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100
JUL 26 1996
| Submitted by: | Michael Halpin
Manager of Regulatory and Clinical Affairs
MediSense, Inc.
266 Second Avenue
Waltham MA 02154 | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Device Name: | Precision QID™ Blood Glucose Test Strip | |
| Common Name: | Reagent test strips for Blood Glucose | |
| Classification: | "Glucose Test System" | Class II per CFR 862.1345 |
| Predicate Devices: | Precision QID™ Blood Glucose Test Strip - K945887
Accu-Chek Advantage Test Strips - K951887 | |
| Description: | The Precision QID Blood Glucose Test Strip utilizes amperometric
biosensor technology to quantitatively measure glucose in whole blood
and control solutions. Insertion of a test strip into the sensor,
automatically turns the sensor on. A drop of whole blood or control
solution is applied to the target area of the test strip and the assay is
automatically initiated. A countdown begins and glucose oxidase
catalyzes the oxidation of glucose to produce gluconic acid. During
the reaction, electrons are transferred by an electrochemical mediator
to the electrode surface, generating a current that is measured by the
Precision QID Sensor. The size of the current is proportional to the
amount of glucose present in the sample, thus giving an accurate
reading of glucose concentration after 20 seconds.
Because the Precision QID Blood Glucose Test Strip is an
evolutionary offspring of the MediSense Pen 2 / Companion 2 Blood
Glucose Test Strip, the Precision QID Blood Glucose Test Strip is
fully compatible with the Pen 2/ Companion 2 Test System
(K901613), the Satellite G Test System (K891695) which has been
renamed to Precision G, The MediSense 2 Pen and Card System
(K944195), and the Precision QID Test System (K944195). | |
| Intended Use: | The Precision QID Blood Glucose Test Strips are intended for in vitro
diagnostic use (i.e., for external use only) for the quantitative
measurement of glucose in fresh capillary whole blood. For home or
professional use with the Precision QID Blood Glucose Sensor.
Compatible with the MediSense 2 Card and Pen Blood Glucose
Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors. | |
1
The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.
Comparison to Predicate Device:
The proposed Precision QID Blood Glucose Test Strip has technological characteristics equivalent to those of the predicate Precision QID Blood Glucose Test Strip (K945887). The proposed Precision QID Test Strip is identical in form, function, material composition, manufacturing process, and equivalent in intended use to the predicate Precision QID Test Strip. The only difference between the proposed device and the predicate device involves label changes to the Precision QID Test Strip Insert Sheet and User's Manual. The proposed labeling expands the intended use and would allow healthcare professionals to use arterial whole blood samples. An additional predicate device, the Accu-Chek Advantage Test Strip (K951887), also allows healthcare professionals to use arterial whole blood samples and has the same intended use as the proposed Precision QID Test Strip in that it is intended for use by professionals and people with diabetes for the quantitative determination of glucose in whole blood.
Performance Studies:
Clinical testing using arterial whole blood was performed at a university medical center by comparison of patient results obtained with the Precision OID Blood Glucose Testing System to results obtained with both a whole blood and a plasma hexokinase reference method. Results for both reference methods are summarized below. In addition. results obtained with the predicate Precision QID Blood Glucose Test Strip using capillary whole blood as compared to a whole blood reference method are included.
| Precision QID Test Strip Results | |||
|---|---|---|---|
| Sample Type Used on | |||
| Precision QID Test Strip | Arterial | ||
| Whole Blood* | Capillary Whole | ||
| Blood** | |||
| Sample Type Used on | |||
| Reference Method | Arterial | ||
| Whole Blood | Arterial | ||
| Plasma | Capillary Whole | ||
| Blood | |||
| Correlation Coefficient (r) | 0.961 | 0.967 | 0.984 |
| Slope (m) | 1.005 | 0.971 | 0.938 |
| Y-intercept, mg/dL | -6.2 | 0.7 | 10.6 |
| N | 320 | 306 | 311 |
| * Results are from pooled data of all test strip lots. |
** Results reported in 510(k) submission #K945887 and used for accuracy performance data in label copy.
2
Conclusion:
Results of clinical testing demonstrate that the performance of the Precision QID Blood Glucose Test Strip using arterial whole blood is acceptable and comparable to the performance of the predicate Precision QID Blood Glucose Test Strip using capillary whole blood and that the Precision QID Blood Glucose Testing System is suitable for its intended use.