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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Precision QID™ Blood Glucose Test Strip:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific correlation coefficient, slope, or y-intercept values. Instead, it presents the results of a comparison study and concludes that the performance is "acceptable and comparable" to the predicate device.

However, based on the context of similar medical device submissions for blood glucose meters, common performance metrics are correlation coefficient, slope, and y-intercept when compared to a reference method. We can infer the reported device performance from the provided table.

Performance Metric	Acceptance Criteria (Inferred from "acceptable and comparable")	Reported Device Performance (Arterial Whole Blood vs. Arterial Whole Blood Ref)	Reported Device Performance (Arterial Whole Blood vs. Arterial Plasma Ref)	Reported Device Performance (Capillary Whole Blood vs. Capillary Whole Blood Ref - Predicate)
Correlation Coefficient (r)	High correlation (e.g., > 0.95)	0.961	0.967	0.984
Slope (m)	Close to 1 (e.g., 0.95 - 1.05)	1.005	0.971	0.938
Y-intercept, mg/dL	Close to 0 (e.g., +/- 10 mg/dL)	-6.2	0.7	10.6

2. Sample Size Used for the Test Set and Data Provenance

Sample Sizes:
- For the study comparing the Precision QID Test Strip using arterial whole blood against an arterial whole blood reference method: N = 320
- For the study comparing the Precision QID Test Strip using arterial whole blood against an arterial plasma reference method: N = 306
- For the study comparing the predicate Precision QID Blood Glucose Test Strip using capillary whole blood against a whole blood reference method: N = 311 (These results were reported in a previous 510(k) submission #K945887)
Data Provenance:
- The current study (arterial whole blood) was performed "at a university medical center." No specific country of origin is mentioned beyond "university medical center."
- The study appears to be prospective, as it describes clinical testing being "performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. While it states the study was done at a "university medical center" and compared to "hexokinase reference methods," it doesn't specify if experts were involved in establishing ground truth beyond running the reference method, nor does it detail their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Adjudication methods are typically relevant for subjective assessments or when multiple readers are interpreting results, which isn't the primary focus here (it's a quantitative measurement device).

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

An MRMC comparative effectiveness study was not conducted. This type of study (AI assistance for human readers) is not relevant for this device, which is a blood glucose test strip, a standalone diagnostic tool, not an AI-powered image interpretation or clinical decision support system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The study directly assesses the performance of the Precision QID Blood Glucose Test Strip (algorithm + associated hardware to read the strip) against recognized laboratory reference methods (hexokinase). This is essentially the "algorithm only" performance for a quantitative measurement device, as the human-in-the-loop is simply applying the sample and reading the digital result.

7. The Type of Ground Truth Used

The ground truth used was reference laboratory methods:

Whole blood hexokinase reference method
Plasma hexokinase reference method

Hexokinase methods are considered highly accurate and are a standard for glucose measurement in clinical laboratories.

8. The Sample Size for the Training Set

This information is not applicable/not provided for this type of device. The Precision QID Blood Glucose Test Strip is based on a chemical reaction (biosensor technology) rather than a machine learning model that requires a training set. The "development" of the device would involve engineering and chemical optimization, not training on a dataset in the way an AI algorithm is trained.

9. How the Ground Truth for the Training Set was Established

As stated above, this question is not applicable as there is no mention or indication of a "training set" in the context of an AI/ML algorithm for this device.

Summary

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K962295

Summary of Safety and Effectiveness

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100

JUL 26 1996

Submitted by:	Michael HalpinManager of Regulatory and Clinical AffairsMediSense, Inc.266 Second AvenueWaltham 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 - K945887Accu-Chek Advantage Test Strips - K951887
Description:	The Precision QID Blood Glucose Test Strip utilizes amperometricbiosensor technology to quantitatively measure glucose in whole bloodand control solutions. Insertion of a test strip into the sensor,automatically turns the sensor on. A drop of whole blood or controlsolution is applied to the target area of the test strip and the assay isautomatically initiated. A countdown begins and glucose oxidasecatalyzes the oxidation of glucose to produce gluconic acid. Duringthe reaction, electrons are transferred by an electrochemical mediatorto the electrode surface, generating a current that is measured by thePrecision QID Sensor. The size of the current is proportional to theamount of glucose present in the sample, thus giving an accuratereading of glucose concentration after 20 seconds.Because the Precision QID Blood Glucose Test Strip is anevolutionary offspring of the MediSense Pen 2 / Companion 2 BloodGlucose Test Strip, the Precision QID Blood Glucose Test Strip isfully compatible with the Pen 2/ Companion 2 Test System(K901613), the Satellite G Test System (K891695) which has beenrenamed 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 vitrodiagnostic use (i.e., for external use only) for the quantitativemeasurement of glucose in fresh capillary whole blood. For home orprofessional use with the Precision QID Blood Glucose Sensor.Compatible with the MediSense 2 Card and Pen Blood GlucoseSensors, and the Companion 2 Card and Pen Blood Glucose Sensors.

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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 onPrecision QID Test Strip	ArterialWhole Blood*	Capillary WholeBlood**
Sample Type Used onReference Method	ArterialWhole Blood	ArterialPlasma	Capillary WholeBlood
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.

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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.

Regulation Number and Section

§ 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.