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.

Device Description

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 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 acceptance criteria and study information for the Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System, based on the provided text:

Important Note: The provided 510(k) summary is very high-level and does not contain detailed quantitative acceptance criteria or specific study results that would typically be found in a full performance study report. The document states that performance studies were conducted and the results were deemed "acceptable and comparable" to the predicate, but it does not provide the specific numerical acceptance thresholds or the exact performance metrics achieved.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (as implied or stated)	Reported Device Performance	Comments
Glucose Measurement	Substantial equivalence to current methods (including predicate device).	"Substantially equivalent to the current methods for blood glucose measurements"	No specific numerical criteria (e.g., % within +/- X mg/dL) or performance data are provided in this summary document.
Ketone Measurement	Substantial equivalence to current methods (including predicate device).	"Substantially equivalent to the current methods for blood glucose measurements"	The document mentions ketone measurement in the intended use and technological characteristics, but the performance study conclusion only explicitly refers to "blood glucose testing." It's highly likely ketone performance was also studied and found acceptable, but the summary doesn't detail it.
Intended Use	Device performs as specified for quantitative measurement of glucose and ß-ketone in fresh capillary, venous, arterial, and neonatal whole blood, for multiple-patient use in professional healthcare settings, as an aid to monitor diabetes control.	Demonstrated to be "acceptable and comparable" when used according to intended use.	The device's use for professional healthcare settings and various blood sample types aligns with the performance claims.
Technological Characteristics	Matching or superior to predicate in key aspects (e.g., enzyme, glucose range, operating conditions, data storage, power source).	Confirmed "same" or "improved" (e.g., barcode scanner, assay time) across all listed characteristics compared to the predicate in the "Comparison to Predicate Device" table.	The device meets or exceeds the specifications of the predicate device for these characteristics.

Summary of Acceptance Criteria: The primary acceptance criterion articulated in this summary is substantial equivalence to existing, legally marketed devices (specifically the Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System). This implies that the new device's performance, particularly in glucose and ketone measurement accuracy and precision, must be comparable to or better than the predicate's established performance, typically within predefined statistical limits. However, the exact numerical thresholds for "substantially equivalent" are not presented here.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The summary mentions "laboratory and clinical settings" and "healthcare professionals" without specifying the number of samples or patients involved.
- Data Provenance: The legal manufacturer is Abbott Diabetes Care Ltd. in Witney, UK. The studies were likely conducted in the UK or other regions where Abbott operates. The document does not specify a country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a new device, these would almost certainly be prospective studies specifically designed to demonstrate performance of the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For blood glucose meters, ground truth is typically established using a highly accurate laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar) rather than human experts.
Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments by multiple human readers (e.g., radiologists interpreting images) to establish a consensus ground truth. For a quantitative device like a blood glucose meter, ground truth is established by objective reference measurements.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- An MRMC study is not relevant here. This device is a standalone diagnostic instrument, not an AI-powered assistive tool for human readers in a diagnostic imaging context. There is no "human reader with AI assistance" component to evaluate.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, this device is inherently a standalone (algorithm only) device in its core function of measuring glucose and ß-ketone. The performance studies described in the summary evaluate the accuracy and precision of the meter itself when operated by healthcare professionals. While a human handles the device, the core measurement and algorithmic processing are automated, making it a standalone performance assessment of the device's analytical capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for quantitative blood tests like glucose and ß-ketone is typically established using a highly precise and accurate laboratory reference method, often an enzymatic reference method traceable to a recognized standard. The document doesn't explicitly state the reference method, but this is the standard practice for such devices.
The sample size for the training set:
- This information is not applicable and not provided. Blood glucose meters do not typically involve "training sets" in the machine learning sense. Their algorithms are based on established electrochemical principles and signal processing, calibrated during manufacturing, rather than being "trained" on a large dataset of patient samples in the way an AI algorithm would be. Calibration data is used, but it's not a "training set" in the common understanding of AI/ML.
How the ground truth for the training set was established:
- This information is not applicable. As explained above, these devices use calibration data, not a "training set" with ground truth established in the same way as for AI models. Calibration involves comparing the device's readings against known concentrations of analytes, usually using traceable reference standards, to ensure accuracy and linearity across the measurement range.

Summary

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KI30094

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.1360 South Loop RoadAlameda, CA 94502
Contact Person:	David G. LambertSenior Regulatory Affairs Specialist
Telephone No.	(510) 749-5105
Fax No.	(510) 864-4791
Date Prepared	January 25, 2013
Device Information:
Proprietary Name(s)	Freestyle Precision Pro Blood Glucose andβ-Ketone Monitoring System
Common Name	i) System, Test, Blood Glucose, Over the counterii) Glucose Dehydrogenase, Glucoseiii) Nitroprusside, Ketones (Urinary, Non-quant.)
Classification Name	i) Glucose Test System (21 CFR 862.1345,Product Code NBW)ii) Glucose Test System (21 CFR 862.1345,Product Code LFR)iii) Ketones (Nonquantitative) Test System (21CFR 862.1435, Product Code JIN)iv) Calculator/data processing module, forclinical use. (21 CFR 862.2100, Product CodeJQP)
Predicate Device	Precision Xceed Pro Blood Glucose andβ-Ketone Monitoring System, cleared underK080960
Legal Manufacturer:	Abbott Diabetes Care Ltd.Range RoadWitneyOxonOX29 0YLUK

Device Description and Technological Characteristics:

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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.

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.

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 BloodGlucose and β-KetoneMonitoring System	Freestyle Precision Pro BloodGlucose andβ-Ketone Monitoring System
Blood Glucose StripSpecifications
Test Strip Enzyme	Glucose Dehydrogenase(NAD dependent)	Same
Glucose Range	20-500 mg/dL	Same
Operating Temperature	59°-104°F	Same
Operating Humidity	10-90%	Same
Sample volume(Glucose)	0.6 µl	Same
Data storage	2,500 patient results1,000 control test results	Same
Power source	2 AA batteries	Same
Characteristic	Predicate	Proposed Device
Indications for Use	Precision Xceed Pro Blood Glucoseand β-Ketone Monitoring SystemThe Precision XCeed Pro BloodGlucose and β-Ketone MonitoringSystem is intended for in vitro (outsidethe body) diagnostic use for thequantitative measurement of glucose(D-glucose) in fresh capillary wholeblood samples. The Precision XCeedPro System is for home (lay user) orprofessional use. The system is not foruse in diagnosing diabetes mellitus, butis to be used as an aid in monitoring theeffectiveness of diabetes controlprograms.Healthcare professionals may also usethe product for the quantitativemeasurement of glucose in venous,arterial, or neonatal whole blood andketone in venous blood, provided thesample is used within 30 minutes aftercollection.	Freestyle Precision Pro Blood Glucose andβ-Ketone Monitoring SystemThe Freestyle Precision Pro Blood Glucose and β-Ketone MonitoringSystem is intended for the quantitative measurement of glucose (sugar)in fresh capillary whole blood from the finger, and from venous, arterialand 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.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. 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.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 (800) 638-2041 or (301) 796-7100 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 system should not be used for the diagnosis of or screening for diabetes.

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)

Page I of

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.