CLEVER CHOICE

K120921 · Simple Diagnostics, Inc. · CGA · Aug 21, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120921
• Device Name: CLEVER CHOICE
• Applicant: Simple Diagnostics, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

System uses electrochemical biosensor technology with glucose oxidase enzyme to measure capillary blood glucose. Input: 0.7 μL capillary blood via test strip capillary action. Operation: Amperometric measurement generates current proportional to glucose concentration; result displayed in 5 seconds. Models include single-patient (Voice+ S, +S) and multiple-patient (Voice+ M, +M) versions; Voice models provide audible results. Used in home or professional settings. Output: Glucose concentration (mg/dL or mmol/L). Healthcare providers/patients use output to monitor diabetes control effectiveness. Multiple-patient models require auto-disabling lancing devices and disinfection protocols. Benefits: Rapid, quantitative glucose monitoring for diabetes management.

Clinical Evidence

Clinical performance evaluated via lay user study (N=100, including 50 visually impaired) and professional method comparison (N=100). Primary endpoints: system accuracy vs. YSI-2300 reference. Results: 99-100% of results within ±15 mg/dL for glucose <75 mg/dL and 98-100% within ±20% for glucose ≥75 mg/dL. AST performance validated across palm, forearm, upper arm, calf, and thigh. Bench testing included precision (CV 2.82-5.94%), linearity (r²=0.9995), altitude (up to 10,744 ft), and disinfection efficacy.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; amperometric detection. Dimensions: 102mm x 58mm x 22mm. Power: 3V DC (CR2032). Connectivity: USB port. Display: LCD. Sterilization: N/A (test strips/lancets). Software: Embedded firmware for glucose calculation and voice output (Voice models).

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, palm, forearm, upper arm, calf, thigh) for diabetes management. For in vitro diagnostic use. Contraindicated for neonates, diabetes diagnosis, or screening. Alternative site testing restricted to steady-state glucose conditions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AG-6951 Single and Multi Blood Glucose Monitoring System (K101307)

Submission Summary (Full Text)

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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 [phone] 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.

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.

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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:<br>AG-6951 Single and Multi Blood<br>Glucose Monitoring System<br>(K101307) | NEW DEVICES:<br>Clever Choice Voice+ S<br>Clever Choice Voice+ M<br>Clever Choice+ S<br>Clever Choice+ M<br>Single and Multi Blood Glucose<br>Monitoring Systems |
|--------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood from<br>AST(Alternative site testing) and<br>finger | Capillary whole blood from<br>AST(Alternative site testing) and<br>finger |
| Sample Application | Blood sample is placed directly to<br>the test strip after finger is lanced. | Blood sample is placed directly to<br>the test strip after finger or AST is<br>lanced. |
| Hematocrit Range | 20-60% | 20-60% |
| Operating Temperature<br>Range | 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:<br>AG-6951 Single and Multi Blood<br>Glucose Monitoring System<br>(K101307) | NEW DEVICES:<br>Clever Choice Voice+ S<br>Clever Choice Voice+ M<br>Clever Choice+ S<br>Clever Choice+ M<br>Single and Multi Blood Glucose<br>Monitoring Systems |
|----------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 500 times with time and date<br>displaying | 500 times with time and date<br>displaying |
| 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<br>(1.1mmol/L~33.3mmol/L) | 20mg/dL-600mg/dL<br>(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.<br>Voice function | USB function.<br>Voice function (or non-voce models)<br>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 [phone]. 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 [phone] or [phone] 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 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 +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 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 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 Voice+ M meters and Clever Choice +M Test Strips.

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

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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 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.

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)

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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 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 qlucose 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.

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) =======================================================================================================================================================================

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