FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM

K130094 · Abbott Diabetes Care · NBW · Jun 27, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130094
• Device Name: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous, arterial, and neonatal whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and β-Ketone 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. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes. The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and β-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, and from venous, arterial, and neonatal whole blood. The Freestyle Precision Pro Blood β-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and β-Ketone Meter to quantitatively measure β-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial, and neonatal whole blood. Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional), a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.

Device Story

Microprocessor-controlled meter; uses electrochemical biosensor test strips to measure glucose or β-ketone. Input: capillary, venous, arterial, or neonatal whole blood applied to test strip. Operation: Glucose dehydrogenase (NAD) or hydroxybutyrate dehydrogenase catalyzes reaction; electrochemical mediator (1,10-phenanthroline quinone) transfers electrons to electrode; meter measures resulting current. Output: quantitative glucose/ketone concentration displayed on screen. Used in professional healthcare settings; operated by clinicians. Features 1D/2D barcode scanner for patient/strip identification. Data transmitted to management systems via docking station, cable, or WiFi. Benefits: rapid point-of-care monitoring of diabetes control; aids clinical decision-making regarding glycemic management.

Clinical Evidence

Laboratory and clinical performance studies conducted by healthcare professionals. Results demonstrate that the meter and test strips provide blood glucose measurements substantially equivalent to the predicate device. No specific numerical sensitivity/specificity metrics provided in summary.

Technological Characteristics

Microprocessor-controlled; injection-molded plastic housing; custom graphic LCD. Sensing: electrochemical biosensor (glucose dehydrogenase). Power: 2 AA batteries. Connectivity: WiFi, docking station, or data cable. Calibration: barcode scanning. Disinfection: Dispatch wipes.

Indications for Use

Indicated for quantitative measurement of glucose and β-ketone in fresh capillary, venous, arterial, and neonatal whole blood in professional healthcare settings to monitor diabetes control programs. Contraindicated for diabetes screening or diagnosis; not for patients in shock, dehydrated, hyperosmolar, or critically ill.

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

• Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System (k080960)

Submission Summary (Full Text)

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KI30094

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#### 510(K) SUMMARY As Required By 21 CFR 807.92

JUN 2 7 2013

According to the requirements of 21 CFR 807.92, the following information provides detail for a determination.

| General Information | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information | Abbot Diabetes Care Inc.<br>1360 South Loop Road<br>Alameda, CA 94502 |
| Contact Person: | David G. Lambert<br>Senior Regulatory Affairs Specialist |
| Telephone No. | [phone] |
| Fax No. | [phone] |
| Date Prepared | January 25, 2013 |
| Device Information: | |
| Proprietary Name(s) | Freestyle Precision Pro Blood Glucose and<br>β-Ketone Monitoring System |
| Common Name | i) System, Test, Blood Glucose, Over the counter<br>ii) Glucose Dehydrogenase, Glucose<br>iii) Nitroprusside, Ketones (Urinary, Non-quant.) |
| Classification Name | i) Glucose Test System (21 CFR 862.1345,<br>Product Code NBW)<br>ii) Glucose Test System (21 CFR 862.1345,<br>Product Code LFR)<br>iii) Ketones (Nonquantitative) Test System (21<br>CFR 862.1435, Product Code JIN)<br>iv) Calculator/data processing module, for<br>clinical use. (21 CFR 862.2100, Product Code<br>JQP) |
| Predicate Device | Precision Xceed Pro Blood Glucose and<br>β-Ketone Monitoring System, cleared under<br>K080960 |
| Legal Manufacturer: | Abbott Diabetes Care Ltd.<br>Range Road<br>Witney<br>Oxon<br>OX29 0YL<br>UK |

### Device Description and Technological Characteristics:

The Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System is a microprocessor-controlled devices that algorithmically process electrical current from a (biosensor) test strip to compute a diabetic patient's blood glucose reading. The meter is fabricated from standard electronic components housed in an injection molded plastic case that

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offers easy test strip alignment and insertion, and a custom graphic liquid crystal display (LCD). The LCD will display menu prompts, icons, results, and data. The meter also includes a function key for turning the unit on/off and to select functions.

The meter requires 2 user replaceable standard AA cell batteries. The Freestyle Precision Pro meter is calibrated by scanning the lot specific bar code on the test strip foil label. An assay cannot be performed until the barcode information has been recorded.

The meter automatically stores the last 2,500 test results, which may be a combination of blood glucose or glucose control results. These results can be recalled and displayed again. Additionally, the meters can store up to 6,000 Operator IDs or 1,000 Quality Control tests.

#### Intended Use: Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System

The Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of ß ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger and venous whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and ß-Ketone 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. This system should only be used with single-use, auto-disabling lancing devices.

The system should not be used for the diagnosis of or screening for diabetes.

The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Freestyle Precision Pro Blood B-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure ß-ketone in fresh capillary whole blood samples drawn from the fingertips.

Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional), a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.

#### Comparison to Predicate Device:

The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System has equivalent technological characteristics to the Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System (cleared under K080960). The test strip has the same intended use as the predicate test strip.

The similarities between the Freestyle Precision Pro and Freestyle Xceed Pro Blood Glucose and B-Ketone Monitoring Systems are highlighted below:

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| | Predicate | Proposed Device |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Precision Xceed Pro Blood<br>Glucose and β-Ketone<br>Monitoring System | Freestyle Precision Pro Blood<br>Glucose and<br>β-Ketone Monitoring System |
| Blood Glucose Strip<br>Specifications | | |
| Test Strip Enzyme | Glucose Dehydrogenase<br>(NAD dependent) | Same |
| Glucose Range | 20-500 mg/dL | Same |
| Operating Temperature | 59°-104°F | Same |
| Operating Humidity | 10-90% | Same |
| Sample volume<br>(Glucose) | 0.6 µl | Same |
| Data storage | 2,500 patient results<br>1,000 control test results | Same |
| Power source | 2 AA batteries | Same |
| Characteristic | Predicate | Proposed Device |
| Indications for Use | Precision Xceed Pro Blood Glucose<br>and β-Ketone Monitoring System<br>The Precision XCeed Pro Blood<br>Glucose and β-Ketone Monitoring<br>System is intended for in vitro (outside<br>the body) diagnostic use for the<br>quantitative measurement of glucose<br>(D-glucose) in fresh capillary whole<br>blood samples. The Precision XCeed<br>Pro System is for home (lay user) or<br>professional use. The system is not for<br>use in diagnosing diabetes mellitus, but<br>is to be used as an aid in monitoring the<br>effectiveness of diabetes control<br>programs.<br><br>Healthcare professionals may also use<br>the product for the quantitative<br>measurement of glucose in venous,<br>arterial, or neonatal whole blood and<br>ketone in venous blood, provided the<br>sample is used within 30 minutes after<br>collection. | Freestyle Precision Pro Blood Glucose and<br>β-Ketone Monitoring System<br>The Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring<br>System is intended for the quantitative measurement of glucose (sugar)<br>in fresh capillary whole blood from the finger, and from venous, arterial<br>and neonatal whole blood, and for the quantitative measurement of β - ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger and venous whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and β-Ketone 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. This system should only be used with single-use, auto-disabling lancing devices.<br><br>The system should not be used for the diagnosis of or screening for diabetes.<br><br>The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and β-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Freestyle Precision Pro Blood β-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and β-Ketone Meter to quantitatively measure β-ketone in fresh capillary whole blood samples drawn from the fingertips.<br><br>Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional), a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured. |
| | Predicate | Proposed Device |
| | Precision Xceed Pro Blood | Freestyle Precision Pro Blood |
| Characteristic | Glucose and B-Ketone | Glucose and |
| | Monitoring System | ß-Ketone Monitoring System |
| Cleaning/Disinfection | Cleaning with cloth dampened | Disinfection with Dispatch wipes |
| | with water or mild detergent | |
| Barcode scanner | laser | ! D/2D camera |
| Blood glucose assay | 20 sec | 5 sec |
| time | | |

The differences between the Freestyle Precision Pro and Freestyle Xceed Pro Blood Glucose and ß-Ketone Monitoring Systems are highlighted below:

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#### Performance Studies:

The performance of the meter and test strip were studied in the laboratory and in clinical settings by healthcare professionals. The studies demonstrated that healthcare professionals can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements, which include the predicate device listed above.

#### Conclusion:

Results of laboratory and clinical testing demonstrate that the performance of the meter and test strip, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G699 Silver Spring, MD 20993-0002

June 27, 2013

Abbott Diabetes Care Inc. C/O David Lambert 1360 South Loop Road ALAMEDA CA 94502

Rc: K130094

Trade/Device Name: Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JQP, JIN Dated: May 24, 2013 Reccived: May 28, 2013

#### Dear Mr. Lambert:

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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Lambert

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Division of Small 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 yours,

# Carol C. Benson -S for

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K130094

Device Name: Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System

Indications for Use:

The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of B-ketone (beta-hydroxybutvrate) in fresh capillary whole blood from the finger and venous, arterial and neonatal whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and B-Ketone 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. This system should only be used with single-use, auto-disabling lancing devices.

The system should not be used for the diagnosis of or screening for diabetes.

The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial and neonatal whole blood. The Freestyle Precision Pro Blood B-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure B-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial and neonatal whole blood.

Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional), a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.

Over the Counter Use Prescription Use X And/Or X (21 CFR Part 801 Subpart D) (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 Diagnostics and Radiological Health (OIR) Denise Johnson-lyles -S 2013.06.26 09:40:30 -04'00' Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

k130094 510(k)

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