FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM

K132511 · Abbott Diabetes Care, Inc. · NBW · Dec 24, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132511
• Device Name: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 24, 2013
• Decision: SESE
• Submission Type: Special
• 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 ß-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 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, autodisabling 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 ß-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 ß-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

The FreeStyle Precision Pro is a microprocessor-controlled, handheld blood glucose and beta-ketone monitoring system for professional healthcare use. It accepts fresh capillary, venous, arterial, or neonatal whole blood samples via test strips. The device uses biosensor technology to measure electrical current from the test strip, which is algorithmically processed to compute glucose or ketone concentrations. The meter features an injection-molded plastic case, a graphic LCD for displaying results and menu prompts, and a barcode scanner for lot-specific test strip calibration. It stores up to 2,500 test results, 6,000 Operator IDs, and 1,000 Quality Control tests. Data can be transmitted to management systems via docking station, cable, or WiFi. Healthcare providers use the output to monitor the effectiveness of diabetes control programs. The device benefits patients by providing rapid, quantitative diagnostic information in clinical settings.

Clinical Evidence

Bench testing only. Verification and validation activities performed to assess impact of hematocrit range extension (15-65%). Disinfection efficacy studies confirmed complete inactivation of Hepatitis B Virus (HBV) using Dispatch Hospital Cleaner Disinfectant Towels with Bleach. Robustness testing confirmed no performance degradation after 10,950 cleaning/disinfection cycles.

Technological Characteristics

Microprocessor-controlled meter; injection-molded plastic housing; graphic LCD; barcode scanner for calibration; powered by two AA batteries. Sensing principle: biosensor measuring electrical current from test strips. Connectivity: docking station, data cable, or WiFi. Software: algorithm-based processing of electrical signals.

Indications for Use

Indicated for quantitative measurement of glucose and beta-ketone in fresh capillary, venous, arterial, and neonatal whole blood in professional healthcare settings to monitor diabetes control programs. Not for diagnosis or screening of diabetes.

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

• Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System (k130094)

Submission Summary (Full Text)

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K132511

Abbott Diabetes Care. Inc.

Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System Special 510(k) Submission

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

DEC 2 4 2013

| General Information | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information | Abbott Diabetes Care, Inc.<br>1360 South Loop Road<br>Alameda, CA 94502 |
| Contact Person | Vrushali Tembe<br>Sr. Regulatory Affairs Specialist |
| Telephone | [phone] |
| Facsimile | [phone] |
| Date | August 9, 2013 |
| Device Information | |
| Proprietary Name | Freestyle Precision Pro Blood Glucose and β-Ketone<br>Monitoring System |
| Common Name | (a) System. Test, Blood Glucose, over the Counter<br>(b) Glucose Dehydrogenase, Glucose<br>(c) Nitroprusside, Ketones (Urinary, Non-quant.) |
| Classification | (a) Glucose Test System (21CFR862.1345), Class II,<br>Product Code NBW<br>(b) Glucose Test System (21CFR862.1345), Class II,<br>Product Code LFR<br>(c) Ketones (Non-quantitative) Test System (21<br>CFR862.1435), Product Code JIN<br>(d) Calculator/Data Processing Module for Clinical Use<br>(21CFR862.2100), Product Code JQP |
| Predicate Device | Freestyle Precision Pro Blood Glucose and β-Ketone<br>Monitoring System, cleared under k130094 |
| Legal Manufacturer | Abbott Diabetes Care, Inc.<br>Range Road<br>Witney<br>Oxon<br>OX29 OYL<br>UK |

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# Device Description and Technological Characteristics:

The Freestyle Precision Pro Blood Glucose and B-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 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:

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 ß-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 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, autodisabling 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 ß-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 ß-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.

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# Comparison to Predicate Device:

The Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System has the same intended use and equivalent technological characteristics to the FreeStyle Precision Pro Blood Glucose and B-Ketone Monitoring System (cleared under k130094). The system is identical to the predicate with the exception of the difference noted.

| | Predicate Device | Subject Device |
|------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Devices | Freestyle Precision Pro<br>Blood Glucose and β-Ketone<br>Monitoring System<br>(k130094) | Freestyle Precision Pro<br>Blood Glucose and β-Ketone<br>Monitoring System |
| Hematocrit | 30%-60% | 15%-65% |

# Standard/Guidance Document Referenced:

CLSI EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition.

ISO 14971:2000. Medical Devices-Application of risk management to medical devices

ISO 15197:2003. In Vitro diagnostic test systems -Requirements for blood-glucose monitoring system for self-testing in managing diabetes mellitus

#### Performance Characteristics:

The performance of the meter and test strip was studied by healthcare professionals. The studies demonstrate 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 testing demonstrate that the performance of the FreeStyle Precision Pro System over the hematocrit range of 15%-65% is acceptable for blood glucose and Bketone testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 24, 2013

ABBOTT DIABETES CARE INC. VRUSHALI TEMBE 1360 SOUTH LOOP ROAD ALAMEDA CA 94502

Re: K132511

Trade/Device Name: FreeStyle Precision Pro Blood Glucose and B-ketone Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JIN, JQP Dated: November 27, 2013 Received: November 29, 2013

Dear Ms. Tembe:

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

If your device is classified (see above) into either 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- Ms. Tembe

... .. .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...

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.htm1.

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k) Number (if known) k132511

#### Device Name

FreeStyle Precision Pro Blood Glucose and B-ketone Monitoring System

#### Indications for Use (Describe)

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 neonaal whole blood, and for the quantitative measurement of for ketone (beatly buty the in fresh capillary whole blood from the finger and venous, arterial, and neonalal whole blood when used within 30 minutes after collection Pro Blood Glucose and f-Ketone Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healtheare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with singleuse, 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 with the Freestyle Presision Pro Blood Glucose and B-Kerone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips and from venous, arerial, and neonatal whole blood. The Freestyle Pro Blood (1-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantiatively measure 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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Stavce

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

.

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