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 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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K132511) does not explicitly state numerical acceptance criteria for blood glucose or β-ketone measurement accuracy. It primarily focuses on demonstrating substantial equivalence to a predicate device by extending the hematocrit range. The key performance characteristic mentioned is the acceptable performance over the hematocrit range of 15%-65%.

Acceptance Criteria	Reported Device Performance (Summary)
Not explicitly stated as numerical accuracy targets (e.g., ISO 15197:2003 accuracy percentages)	The FreeStyle Precision Pro System demonstrated acceptable performance for blood glucose and β-ketone testing over the hematocrit range of 15%-65%.
Substantial Equivalence to predicate device (K130094) for intended use and technological characteristics	The device is identical to the predicate device with the exception of the extended hematocrit range.

Important Note: The document mentions ISO 15197:2003 as a referenced standard, which does specify accuracy criteria for blood glucose monitoring systems. However, these specific criteria and how the device met them are not detailed in this 510(k) summary. The summary focuses on the change from the predicate (hematocrit range) and that the performance is "acceptable."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided text. The summary mentions "laboratory testing" and that "the performance of the meter and test strip was studied by healthcare professionals," but does not give a specific number of samples or patients.
Data Provenance: Not explicitly stated. The document indicates "laboratory testing" and studies by "healthcare professionals," but does not specify the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned. The studies were conducted by "healthcare professionals," but their specific qualifications (e.g., specific medical specialty, years of experience) are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device is for quantitative blood glucose and β-ketone measurement, and the studies described focus on the analytical performance of the system itself against established methods (implied through substantial equivalence to the predicate) and across a new hematocrit range. There is no mention of human reader interpretation or AI assistance in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone Performance: Yes, this is inherently a standalone performance study. The FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System is a device designed to algorithmically process electrical current from a test strip to compute a blood glucose or β-ketone reading. The performance characteristics described are those of the device itself (meter and test strip) in measuring these analytes. There is no human interpretation component in the direct measurement of glucose/ketone levels by the device.

7. Type of Ground Truth Used

Type of Ground Truth: Implied to be a reference method or predicate device comparison. The summary states, "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." This suggests that the device's readings were compared against accepted laboratory reference methods for glucose and β-ketone, or directly against the predicate device (K130094) which itself would have been validated against reference methods.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a separate "training set" in the conventional AI sense. The "algorithm" within this device refers to the microprocessor's programmed processing of electrical currents from the biosensor, which is based on electrochemical principles, not learned from a dataset.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set in the AI sense for this device. The device's internal algorithms would be developed and calibrated based on chemical and electrical engineering principles, validated against known standards and reference methods during its design and development phases.

Summary

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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.1360 South Loop RoadAlameda, CA 94502
Contact Person	Vrushali TembeSr. Regulatory Affairs Specialist
Telephone	(510) 864 4487
Facsimile	(510) 864-4791
Date	August 9, 2013
Device Information
Proprietary Name	Freestyle Precision Pro Blood Glucose and β-KetoneMonitoring System
Common Name	(a) System. Test, Blood Glucose, over the Counter(b) Glucose Dehydrogenase, Glucose(c) Nitroprusside, Ketones (Urinary, Non-quant.)
Classification	(a) Glucose Test System (21CFR862.1345), Class II,Product Code NBW(b) Glucose Test System (21CFR862.1345), Class II,Product Code LFR(c) Ketones (Non-quantitative) Test System (21CFR862.1435), Product Code JIN(d) Calculator/Data Processing Module for Clinical Use(21CFR862.2100), Product Code JQP
Predicate Device	Freestyle Precision Pro Blood Glucose and β-KetoneMonitoring System, cleared under K130094
Legal Manufacturer	Abbott Diabetes Care, Inc.Range RoadWitneyOxonOX29 OYLUK

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Device Description and Technological Characteristics:

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.

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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 ProBlood Glucose and β-KetoneMonitoring System(K130094)	Freestyle Precision ProBlood Glucose and β-KetoneMonitoring 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 (800) 638-2041 or (301) 796-7100 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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This section applies any to requirements of the Paperwork Reduction Act of 1985.

'do not send your completed form to the pra staff email adoress below.

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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.