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The ReliOn Premier BLU Blood Glucose Monitoring System is comprised of the ReliOn Premier BLU Blood Glucose Meter and the ReliOn Premier Blood Glucose Test Strips.

The ReliOn Premier BLU Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.

The ReliOn Premier BLU Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The system is intended to be used by a single person and should not be shared.

The system is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The ReliOn Premier BLU Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology that the meter communicates to smartphones wirelessly. The ReliOn Premier BLU BGMS has a target range indicator that upon consulting with a healthcare professional, users have the option to activate the function that displays blood glucose measurement results on a colored backlight display. By default, this indicator function is set to OFF. However, it is recommended that users consult with a healthcare professional to determine the target range for their individual needs.

This document describes the FDA's 510(k) clearance for the ReliOn Premier BLU Blood Glucose Monitoring System, comparing it to a predicate device. The information required for a comprehensive study description, such as that for an AI-based medical device, is not provided in this document. This submission focuses on engineering modifications of an existing device and its equivalence to a predicate, not on a new algorithm's performance or a comparative effectiveness study involving human readers and AI.

Therefore, many of the requested details, particularly regarding AI-specific studies (e.g., MRMC studies, standalone algorithm performance, training data details, expert consensus for ground truth on AI models), are not applicable to this submission.

However, I can extract the information relevant to the device's technical specifications and the non-clinical testing performed.

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of precise quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision) or detailed reported device performance data as would be seen for a new algorithm study. Instead, it describes equivalence to a predicate device and mentions that the non-clinical tests indicated the device "performed as intended and fulfilled the specifications."

The key performance characteristics are compared to the predicate device:

Acceptance Criteria (Implied from the document):
The acceptance criteria are implicitly that the ReliOn Premier BLU Blood Glucose Monitoring System demonstrates "substantial equivalence" to the predicate device, CareSens N Premier BT Blood Glucose Monitoring System (K170614), and that the modifications (target range function, LCD, PCB, labeling) perform as intended and fulfill specifications. Specific quantitative criteria for accuracy, precision, or other performance metrics (e.g., ISO standards for blood glucose meters) are not detailed in this summary.

Reported Device Performance:
"The results of these tests indicated that the ReliOn Premier BLU Blood Glucose Monitoring System, with the proposed changes outlined in this document, performed as intended and fulfilled the specifications."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any test set (e.g., number of subjects or samples used in the non-clinical tests like software function, power consumption, etc.).
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified for the non-clinical tests mentioned. Given the manufacturer's location, testing likely occurred in South Korea, but this is not confirmed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The ground truth for a blood glucose monitoring system is typically established against a laboratory reference method (e.g., YSI analyzer) for glucose concentration, not by human experts interpreting results. The document does not mention any expert involvement in establishing ground truth for the non-clinical tests.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in imaging or clinical trial contexts. This document describes non-clinical engineering and performance tests for a blood glucose meter.

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

This is not applicable. This document describes a continuous glucose monitoring system, not an AI imaging or diagnostic tool that assists human readers. No MRMC study was conducted or mentioned.

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

This is not applicable in the context of an AI algorithm. This device is a measurement system; its "standalone performance" refers to its accuracy in measuring blood glucose, which is evaluated through specific performance studies (e.g., accuracy against a reference method, precision studies). While these types of studies were undoubtedly performed as part of the overall testing (likely consistent with ISO 15197 for blood glucose monitoring systems, though not explicitly stated in this summary), the details of such quantitative performance studies are not provided in this 510(k) summary. The summary only broadly states that the device "performed as intended and fulfilled the specifications."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a blood glucose monitoring system, the ground truth for glucose measurements is typically established using a laboratory reference method (e.g., YSI glucose analyzer) on venous plasma or serum samples. This is a highly accurate chemical measurement. The document does not explicitly state the ground truth method but this is standard practice for blood glucose meter validation.

8. The sample size for the training set

This is not applicable. This document describes a medical device (blood glucose meter), not an AI model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. As above, this is an engineering device, not an AI model with a training set.

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LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. It has nine levels of penetration depths. LDE4 lancing device is compatible with CareSens lancets, Soft series disposable blood lancet from SteriLance and most other blood lancets.

The provided text is a 510(k) summary for the LDE4 Lancing Device. It details the device's technical characteristics and the performance data submitted to support its substantial equivalence to a predicate device. However, it does not contain a typical acceptance criteria table with reported device performance in distinct metrics like sensitivity, specificity, accuracy, or F1 score, which are common for AI/ML-based diagnostic devices. This document focuses on demonstrating that the lancing device performs its intended mechanical function, is biocompatible, and can be properly cleaned and disinfected.

Based on the information provided, here's a breakdown of the requested elements:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide specific numerical acceptance criteria in the format of a typical diagnostic device performance table (e.g., sensitivity, specificity). Instead, the performance evaluations verify that the device functions as intended and meets safety standards. The "acceptance criteria" are implied by the successful completion and positive results of the various tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state sample sizes for each particular test type. For instance, the number of devices or material samples used for biocompatibility or cleaning/disinfection validation is not specified. The studies appear to be prospective bench tests and laboratory evaluations, not clinical trials with human subjects as a "test set" in the context of diagnostic AI. The provenance is implied to be laboratory testing conducted by the manufacturer or its contract labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the provided document. The LDE4 Lancing Device is a mechanical device, and its performance evaluation does not involve establishing ground truth through expert consensus as would be typical for image-based diagnostic AI. The "ground truth" here is objective physical measurements and established biological/chemical testing standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretation, which is not relevant for the type of bench testing described for a lancing 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

This information is not applicable. The LDE4 Lancing Device is a standalone mechanical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.

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

This information is not applicable. The LDE4 Lancing Device is a mechanical lancing device, not an algorithm, and therefore does not have "standalone" AI performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance described in this document is based on:

• Established physical and chemical standards: For puncture depth measurements, material properties, and mechanical functionality.
• Standardized biological testing methods: For biocompatibility (ISO 10993-1) and virus inactivation efficacy.

8. The sample size for the training set

This information is not applicable. The LDE4 Lancing Device is a mechanical device and does not utilize a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for a mechanical lancing device.

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The CareSens N Feliz BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Feliz BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The CareSens N Feliz BT Blood Glucose Monitoring System is comprised of the CareSens N Blood Glucose Test Strips and the CareSens N Feliz BT Blood Glucose Meter.

This FDA 510(k) clearance letter for the CareSens N Feliz BT Blood Glucose Monitoring System does not contain the detailed information required to answer all the questions about specific acceptance criteria and the study that proves the device meets those criteria.

The letter primarily confirms that the device is substantially equivalent to a predicate device and outlines regulatory obligations. It does not include performance data, study design details, or specific acceptance criteria for analytical or clinical performance characteristics of the glucose monitoring system.

Therefore, I cannot provide a complete answer with the requested information based only on the provided text.

However, based on common practices for glucose monitoring systems, I can infer some general aspects and state what information is missing.

Here's an assessment based on the available text and what would typically be found in a 510(k) submission for such a device:

1. A table of acceptance criteria and the reported device performance

Information Not Provided in the Text. The FDA 510(k) letter does not include a table of acceptance criteria or performance data. For a blood glucose monitoring system, this table would typically refer to the ISO 15197 standard (or equivalent FDA guidance) for accuracy of blood glucose measurements.

Typical Acceptance Criteria (Inferred, not from provided text):

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The KetoSens BT Blood ß-Ketone Monitoring System is intended for the quantitative measurement of 0-Ketone (betahydroxybutyrate) level in capillary whole blood drawn from the fingertip. The KetoSens BT Blood β-Ketone Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of ketoacidosis control. The system is not intended for use in the diagnosis of or screening for ketoacidosis and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.

The KetoSens Blood 0-Ketone Test Strips work with the KetoSens BT Blood 0-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the finger.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert involvement. The document primarily consists of an FDA 510(k) clearance letter for the KetoSens BT Blood $\beta$ -Ketone Monitoring System, outlining its indications for use and regulatory compliance. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.

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The CareSens S Clear BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens S Clear BT Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The CareSens S Blood Glucose Test Strips are for use with the CareSens S Clear BT Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Not Found

This is an FDA 510(k) clearance letter for a medical device (CareSens S Clear BT Blood Glucose Monitoring System), not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria, device performance, or study specifics like sample sizes, ground truth establishment, or expert qualifications.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. The "Indications for Use" section (page 2) describes what the device is intended for, but it does not present acceptance criteria or performance data for meeting those criteria.

To answer your questions, one would need to access the full 510(k) submission, which is typically not publicly available in its entirety in this format. The 510(k) submission would contain the detailed studies and data to demonstrate substantial equivalence, including performance data against specific acceptance criteria.

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The CareSens S Fit BT Blood Glucose Monitoring System consists of the CareSens S Fit BT Blood Glucose Meter and the CareSens S Blood Glucose Test Strips. The CareSens S Fit BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens S Fit BT Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The CareSens S Fit BT Blood Glucose Monitoring System consists of the CareSens S Fit BT Blood Glucose Meter and the CareSens S Blood Glucose Test Strips.

This FDA 510(k) clearance letter does not contain the specific acceptance criteria, study details, and performance data requested. It primarily grants market clearance for the CareSens S Fit BT Blood Glucose Monitoring System based on substantial equivalence to predicate devices.

To answer your questions, I would need access to the actual 510(k) submission summary or a separate performance study report for the device. The provided document only includes:

• Trade/Device Name: CareSens S Fit BT Blood Glucose Monitoring System
• Regulation Number: 21 CFR 862.1345
• Regulation Name: Glucose test system
• Regulatory Class: Class II
• Product Code: NBW
• Indications for Use: The system is intended for quantitative measurement of glucose in fresh capillary whole blood samples from fingertips, for self-testing by people with diabetes at home to monitor diabetes control. It is for single-person use, not for neonates, and not for diagnosis or screening of diabetes.
• Type of Use: Over-The-Counter Use

Without the actual study data, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

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The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites such as the forearm, palm, thigh, and calf. Alternate site testing should be used only during steady-state blood glucose conditions. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips.

Here's a breakdown of the acceptance criteria and study information for the ReliOn™ Premier Classic Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only touches upon the regulatory approval and indications for use. It does not include a table explicitly stating acceptance criteria or detailed performance results against those criteria. Clinical performance data, often presented in tables conforming to ISO standards (e.g., ISO 15197 for blood glucose monitoring systems), would typically be found in the full 510(k) submission but are not present in this summary.

To illustrate what such a table would look like for a blood glucose monitoring system, I'll describe typical acceptance criteria based on ISO 15197 (a common standard for such devices), and then indicate that the provided document does not contain the performance data.

Hypothetical Table (Based on typical ISO 15197 standards; performance data not in document):

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The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Express Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Connex Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Connex Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The GLUCOCARD Shine Express Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Express Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The two candidate test systems are derived from the same design platform as their predicate device, CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System (K170614). The candidate devices are modified versions of the predicate device to suit the market needs for test systems with Bluetooth and talking features. The GLUCOCARD Shine Connex Blood Glucose Meter is a Bluetooth meter, similar to the CareSens N Premier BT Blood Glucose Meter, whereas the GLUCOCARD Shine Express Blood Glucose Meter is enabled with a talking feature (English and Spanish).

Both candidate devices are used with the GLUCOCARD Shine Blood Glucose Test Strip and GLUCOCARD Shine Glucose Control Solution, which are the same in chemical composition, fundamental scientific technology, intended use and operating principle as with the components of the predicate device, cleared in K170614. The only difference between the test strip & control solution of the candidate device and the ones of the predicate device is the brand name.

This is a medical device application for two blood glucose monitoring systems, GLUCOCARD Shine Connex and GLUCOCARD Shine Express. As such, the acceptance criteria are based on established performance standards for blood glucose meters, primarily ISO 15197:2013 or equivalent.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for accuracy or precision, nor does it provide specific numerical performance results for the new devices. However, it does refer to "pre-determined Pass/Fail criteria" and concludes that the device passed "all of the tests."

For blood glucose monitoring systems, a common standard for accuracy is ISO 15197:2013, which typically requires:

• **For glucose concentrations

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The CareSens S Fit Blood Glucose Monitoring System is intended for the surement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens S Fit Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The CareSens S Blood Glucose Test Strips are with the CareSens S Fit Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The CareSens S Fit BGMS is a derivation from the same design file as it predicate device, CareSens N Premier and CareSens N Premier BT Blood Glucose Monitoring System, utilizing a new test strip. This Premarket Notification (510(k) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device.

The CareSens S Fit BGMS consists of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Level 1" and "Level 2" ranges). The CareSens S Fit BGMS is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The following items are included in the CareSens S Fit BGMS Blood Glucose Monitoring system:

• 1 CareSens S Fit Blood Glucose Meter
• 10 CareSens S Blood Glucose Test Strips
• 1 Lancing device
• 10 Lancets
• 1 Owner's Booklet
• 1 Quick Reference Guide
• 1 Battery (3.0V lithium battery)

The following items are compatible with the CareSens S Fit BGMS and are available separately.

• CareSens S Blood Glucose Test Strips
• CareSens S Glucose Control Solution

The provided text describes the performance testing and acceptance criteria for the CareSens S Fit Blood Glucose Monitoring System, particularly in the context of its 510(k) submission (K180866) to the FDA.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document frequently refers to "acceptance criteria" and "satisfying" or "meeting" them, particularly referencing the FDA SMBG Guidance (2016). While specific numerical acceptance criteria for each test (e.g., CV% for precision above a certain threshold) are often implied rather than explicitly stated in a single table, the key accuracy criteria from the Method Comparison/User Performance study are provided.

• For glucose concentrations 250 mg/dL and

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KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood B-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.

The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip.

KetoSens Multi Blood p-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices.

The KetoSens Multi Blood p-Ketone Test Strips work with Blood ß-Ketone Meter to quantitatively measure Blood B-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.

The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System consists of a meter, single use test strips, and control solutions with two different B-Ketone concentrations ("Control A" and "Control B" ranges).

The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the Blood ß-Ketone level in whole blood samples using a small electrical current generated in the test strips.

This document focuses on the KetoSens Blood β-Ketone Monitoring System and its validation studies. It describes various performance tests conducted to ensure the device meets specified criteria, primarily focusing on accuracy, precision, and usability.

Here's an organized breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table labeled "Acceptance Criteria." However, acceptance criteria are implicitly stated within the "System Accuracy Test" and "Consumer Study" results, and "Repeatability Test" and "Intermediate Precision Test" conclusions.

General user tests: 185/185 (100%) within ± 0.3 mmol/L (for ketone Trained user tests: 185/185 (100%) within ± 0.3 mmol/L (for ketone Capillary: 124/124 (100%) within ± 0.3 mmol/L for Venous: 121/123 (98.4%) within ± 0.3 mmol/L for

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