The Clever Choice Voice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice Voice+ S 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 Clever Choice Voice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady- state times (when glucose is not changing rapidly). The Clever Choice Blood Glucose Test +S Test Strips are for use with the Clever Choice Voice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ S meters and Clever Choice +S Test Strips.

The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice + M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly). The Clever Choice Blood Glucose +M Test Strips are for use with the Clever Choice Voice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device.

The Clever Choice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice+ S 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 Clever Choice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady- state times (when glucose is not changing rapidly). The Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ S meters and Clever Choice +S Test Strips.

The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice Voice+ M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly). The Clever Choice Blood +M Glucose Test Strips are for use with the Clever Choice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device.

Device Description

Clever Choice Voice+ S Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and the control solutions.

Clever Choice Voice+ M Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, multi use test strips, and the control solutions.

The four blood Glucose Monitoring system models are all based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. All of them use the same technological characteristics for testing with their predicate device. The appearance is different from their predicate device. The new Blood Glucose Monitoring Systems have a function of ejecting the used test strip, which is also different from their predicate device.

AI/ML Overview

The provided 510(k) summary for the Simple Diagnostics Clever Choice Blood Glucose Monitoring Systems states that performance testing was conducted according to ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. However, the summary does not provide a detailed table of acceptance criteria or the specific reported device performance values against those criteria. It also lacks detailed information about the study design that would allow for a complete description of the elements requested in the prompt (sample sizes, expert qualifications, etc.).

Based on typical requirements for blood glucose monitoring systems and the information provided, here's an attempt to answer the questions, noting where information is missing:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states compliance with ISO 15197. This standard specifies accuracy criteria for blood glucose meters. Typical criteria for ISO 15197 are:

Glucose Concentration (mg/dL)	Acceptance Criteria (Deviation from Reference)	Device Performance (Not explicitly stated in the document)
< 75 mg/dL	≥ 95% of results within ± 15 mg/dL	Not provided
≥ 75 mg/dL	≥ 95% of results within ± 20%	Not provided

Note: The 510(k) summary only states that "Non-clinical test and clinical testing was done according to the above standard." It does not present the actual numerical results demonstrating this compliance for the Clever Choice systems. It implicitly states that the new devices were found to be substantially equivalent to the predicate device, which would imply they meet similar performance standards.

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

Sample Size for Test Set: Not explicitly stated in the provided document.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical testing for ISO 15197 typically involves prospective collection of capillary blood samples from human subjects.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. For blood glucose monitoring systems, the "ground truth" (reference method) is usually established by a laboratory analyzer using a highly accurate method (e.g., YSI analyzer, hexokinase method), not by human experts. The operators performing the tests would be healthcare professionals or trained individuals.

4. Adjudication method for the test set:

Given that blood glucose measurements typically rely on a reference laboratory method rather than qualitative expert interpretation, an adjudication method in the traditional sense (e.g., 2+1, 3+1 for image analysis) is not applicable. The reference method provides a definitive numerical value.

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:

Not applicable. This device is a blood glucose monitoring system, which directly measures glucose levels. It is not an AI-powered diagnostic imaging or interpretation system that would involve "human readers" or AI assistance in that context. Its performance is evaluated against a reference laboratory method.

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

Yes, in essence. Blood glucose meters operate in a standalone manner. The device itself (meter and test strip) performs the measurement and displays the result. While a human initiates the test and reads the result, the core "algorithm" (the electrochemical reaction and conversion to a glucose value) functions without human intervention in the measurement process. The performance against the reference method (as per ISO 15197) is a standalone performance evaluation.

7. The type of ground truth used:

Reference Laboratory Method: For blood glucose monitoring systems, the ground truth is established by a highly accurate laboratory analyzer (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or a method traceable to an international reference standard like the hexokinase method). This is considered an objective, high-accuracy measurement.

8. The sample size for the training set:

Not applicable/Not provided. For a traditional electrochemical biosensor like this, there isn't a "training set" in the machine learning sense. The device's calibration and performance characteristics are determined by its physical and chemical design, manufacturing processes, and quality control. Initial characterization and chemical stability studies would be performed during development, but it's not a "training set" for an algorithm.

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

Not applicable/Not provided. As there is no "training set" in the AI or machine learning sense for this type of device, the concept of establishing ground truth for a training set does not apply. The device's core functionality relies on established electrochemical principles, not a learnable algorithm.

Summary

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Simple Diagnostics®

AUG 2 1 2012

510(k) Summary K120921

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 Submitter's information

Simple Diagnostics

11555 Heron Bay Blvd., Suite 200 Coral Springs, Florida 33076 Contact: Muhammad Arif, President, Phone (877) 342-2385 Date of Prepared: 06/10/2012

2.0 Device information

Trade names: (Multiple Models) Clever Choice Voice+ S; Clever Choice Voice+ M; Clever Choice+ S; Clever Choice+ M Blood Glucose Monitoring System Common name:

3.0 Classification

Production code: NBW- Blood Glucose Monitoring System. Requlation number: 862.1345 Classification: Class II Classification name: Blood Glucose Monitoring System Clinical Chemistry Panel:

4.0 Predicate device information

Manufacturer: Andon Medical Co., Ltd. AG-6951 Single Blood Glucose Monitoring System Device: AG-6951 Multi Blood Glucose Monitoring System 510(k) number: K101307

5.0 Device description

Clever Choice Voice+ S Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and the control solutions.

Clever Choice Voice+ M Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, multi use test strips, and the control solutions.

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6.0 Intended use (for all four models)

6.1 The Clever Choice Voice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice Voice+ S 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 Clever Choice Voice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady- state times (when glucose is not changing rapidly). The Clever Choice Blood Glucose Test +S Test Strips are for use with the Clever Choice Voice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ S meters and Clever Choice +S Test Strips.
6.2 The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice + M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly). The Clever Choice Blood Glucose +M Test Strips are for use with the Clever Choice Voice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device.
6.3 The Clever Choice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice+ S 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 Clever Choice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for

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diabetes, nor for neonatal use. Alternative site testing should be done only during steady- state times (when glucose is not changing rapidly). The Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ S meters and Clever Choice +S Test Strips.

6.4 The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice Voice+ M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady – state times (when glucose is not changing rapidly). The Clever Choice +M Blood Glucose Test Strips are for use with the Clever Choice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device.

CHARACTERISTICS	PREDICATE:AG-6951 Single and Multi BloodGlucose Monitoring System(K101307)	NEW DEVICES:Clever Choice Voice+ SClever Choice Voice+ MClever Choice+ SClever Choice+ MSingle and Multi Blood GlucoseMonitoring Systems
Detection Method	Amperometry	Amperometry
Enzyme	Glucose Oxidase	Glucose Oxidase
Type of Meter	Biosensor (Electrode)	Biosensor (Electrode)
Sample Source	Capillary whole blood fromAST(Alternative site testing) andfinger	Capillary whole blood fromAST(Alternative site testing) andfinger
Sample Application	Blood sample is placed directly tothe test strip after finger is lanced.	Blood sample is placed directly tothe test strip after finger or AST islanced.
Hematocrit Range	20-60%	20-60%
Operating TemperatureRange	10°C~40°C(50°-104°F)	10°C~40°C(50°-104°F)
Dimensions	52mmx 92mmx 21mm	102mm×58mm ×22mm
Display	LCD	LCD

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CHARACTERISTICS	PREDICATE:AG-6951 Single and Multi BloodGlucose Monitoring System(K101307)	NEW DEVICES:Clever Choice Voice+ SClever Choice Voice+ MClever Choice+ SClever Choice+ MSingle and Multi Blood GlucoseMonitoring Systems
Result Presentation	mg/dL or mmol/L	mg/dL or mmol/L
Memory Capabilities	500 times with time and datedisplaying	500 times with time and datedisplaying
Test Start	Automatic	Automatic
Test Time	5 second	5 second
Power Source	DC 3V (CR2032)	DC 3V (CR2032)
Battery Life	Approx. 500 normal tests	Approx. 500 normal tests
Measurement Range	20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/L)	20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/L)
Qualified Test Strip	AGS-1100 Test Strip	Clever Choice Test Strip
Sample Volume	Minimum 0.7 micro liter	Minimum 0.7 micro liter
Other function	USB function.Voice function	USB function.Voice function (or non-voce models)Eject the used test strip

8.0 Performance summary

Clever Choice Voice+ S, Clever Choice Voice+ M, Clever Choice+ S, and the Clever Choice+ M Single and Multi blood glucose monitoring systems conform to the following standards:

ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.

Non-clinical test and clinical testing was done according to the above standard.

9.0 Comparison to the predict device and the conclusion

Clever Choice Voice+ S (Single) is similar to the predicate device AG-6951 Single, the two devices are both for single person use, they use the same test strip, and can test the blood glucose at the alternative site. The hematocrit range, the altitude, the memory capability, the battery life and the use function are all the same. Only the appearance is different, and Clever Choice Voice+ S (Single) adds a function of ejecting the used test strip. The Clever Choice S omits the voice function.

Clever Choice Voice+ M (Multi) is similar to the predicate device AG-6951 Multi, the two devices are both for multi person use, they use the same test strip, and can test the blood glucose at the alternative site. The hematocrit range, the altitude, the memory capability, the battery life and the use function are all the same. Only the appearance is different, and Clever Choice Voice+ M Multi adds a function of ejecting the used test strip.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness. The Clever Choice M omits the voice function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Simple Diagnostics c/o Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, FL 34114

AUG 2 1 2012

Re: K120921

Trade/Device Name: Clever Choice Voice+ S Blood Glucose Monitoring System Clever Choice + S Blood Glucose Monitoring System Clever Choice Voice+ M Blood Glucose Monitoring System Clever Choice + M Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: August 10, 2012 Received: August 17, 2012

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, representing health, services, and people. The text "HEALTH SERVICES - USA" is arranged in a circular pattern around the top of the logo, while "DEPARTMENT OF HEA" is on the left side.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at Nitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 prease note the regulation official "Mibreally postmarket surveillance, please contact CDRH 's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Sul valiations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

You may obtain other general information on your responsibilities under the Act from the Tou may of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely vours.

signature

Counney H. Lias, Ph.D. Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K120921

Device Name: Clever Choice Voice+ S Blood Glucose Monitoring System

Indications For Use:

The Clever Choice Voice+ S 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 Clever Choice Voice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice Voice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ S meters and Clever Choice +S Test Strips.

Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use √· (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Suite cl

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety K120921 510(k)

Page 1 of 4

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510(k) Number (if known): K120921

Device Name: Clever Choice Voice+ M Blood Glucose Monitoring System

Indications For Use:

The Clever Choice Voice+ M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).

The Clever Choice +M Blood Glucose Test Strips are for use with the Clever Choice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

Only auto-disabling, single use lancing devices may be used with this device.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or ·

Over the Counter Use √ (21 CFR Part 801 Subpart C)

(Please Do Not WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Vite C Division Sign-Off Office of In Vitro Diagnostic Device . Evaluation and Safety 510(k) k 1 2 = 9 2 l

Page 2 of 4

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510(k) Number (if known): K120921

Device Name: Clever Choice+ S Blood Glucose Monitoring System

Indications For Use:

The Clever Choice+ S 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 Clever Choice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

Prescription Use (21 CFR Part 801 Subpart D)

Over the Counter Use And/Or (21 CFR Part 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, ,Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Auto (=============================================================================================================================================================================

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 5120921 510(k)

Page 3 of 4

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510(k) Number (if known): K120921

Device Name: Clever Choice+ M Blood Glucose Monitoring System

Indications For Use:

The Clever Choice Blood +M Glucose Test Strips are for use with the Clever Choice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

Only auto-disabling, single use lancing devices may be used with this device.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Olutel C

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety Kizogz 510(k) =======================================================================================================================================================================

Page 4 of 4

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.