The FreeStyle Connect Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

Device Description

The FreeStyle Connect monitor utilizes coulometric biosensor technology found in the FreeStyle Connect test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Connect BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.

AI/ML Overview

The provided text describes a 510(k) summary for the FreeStyle Connect™ Blood Glucose Monitoring System. The information is limited to establishing substantial equivalence to a predicate device and does not detail specific acceptance criteria or an in-depth study proving the device meets said criteria with specific performance metrics beyond a statement of "acceptability and comparability."

Therefore, based only on the provided text, I can infer the following:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. It broadly states: "The results obtained during these studies demonstrated that the FreeStyle Connect BGMS is substantially equivalent to the predicate devices." and "Results of laboratory testing demonstrated that the performance of the FreeStyle Connect BGMS is acceptable and comparable to the performance of the predicate devices for blood glucose testing when used according to its intended use."

Without specific numerical cutoffs for accuracy, precision, or other performance characteristics, a table cannot be fully constructed.

2. Sample sized used for the test set and the data provenance:

The document mentions "laboratory testing" and "performance studies" but does not specify the sample size used for the test set, nor does it provide the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide any information regarding experts used to establish ground truth or their qualifications. Blood glucose monitoring systems typically use a reference method for ground truth, such as a laboratory analyzer, rather than expert consensus on images.

4. Adjudication method for the test set:

The document does not mention any adjudication method for the test set. Given the nature of a blood glucose monitoring system, adjudication in the sense of reconciling reviewer disagreements on, for example, image interpretation, would not be applicable.

5. 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:

This question is not applicable to a blood glucose monitoring system. MRMC studies and AI assistance for human readers are relevant to imaging diagnostics or other fields where human interpretation is a primary component of diagnosis, not for automated quantitative measurements from a device like a blood glucose meter. The FreeStyle Connect BGMS is an in vitro diagnostic device that provides a quantitative measurement of glucose.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The FreeStyle Connect Blood Glucose Monitoring System is inherently a standalone device in its core function. It measures glucose electrochemically based on biosensor technology. Its performance, as described, would be "algorithm only without human-in-the-loop performance" in terms of generating the glucose value. The "performance studies" mentioned would reflect this standalone performance.

7. The type of ground truth used:

While not explicitly stated, for a blood glucose monitoring system, the ground truth for performance studies is typically established by a reference laboratory method or a highly accurate laboratory analyzer (e.g., YSI analyzer) that provides a validated glucose concentration. The document states it measures "glucose concentration in whole blood samples," implying comparison against a gold standard for blood glucose measurement. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

The document does not specify any sample size for a training set. For a device utilizing biosensor technology and electrochemical measurement as described, "training set" in the context of machine learning is not directly applicable in the same way as it would be for an AI-powered image analysis system. The development would involve calibration and validation based on chemical and electrical principles rather than iterative training on large datasets in the AI sense.

9. How the ground truth for the training set was established:

As above, the concept of a "training set" in the AI sense is unlikely to apply directly to this device. If there were any development data (akin to training), the ground truth would similarly be established using reference laboratory methods/analyzers for glucose concentration.

Summary

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K05/802

Image /page/0/Picture/1 description: The image shows the word "ABBOTT" with a stylized "a" to the left of the word. The word is written in a simple, sans-serif font. The stylized "a" is a geometric shape that resembles a lowercase "a" but is made up of straight lines and sharp angles.

AUG 9 - 2005

Abbott Laboratories Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502

Telephone 510-749-5400 Facsimile 510-239-2799 www.abbott.com

510(k) Summary

Per 21 CFR §807.92

Company	Abbott Laboratories / TheraSense Inc.
Division	Abbott Diabetes Care
Street Address	1360 South Loop Road
City, State Zip	Alameda, CA 94502
Phone	510-749-5400
Contact Person:	Kimberley Kline510-749-5478kimberley.kline@abbott.com
Proprietary Name:	FreeStyle Connect™ Blood Glucose MonitoringSystem
Common Name:	Blood Glucose Meter and Reagent Test Strips
Classification Number:	21 CFR §862.1345
Predicate Device:	Precision PCx Blood Glucose Monitor andFreeStyle 600 Blood Glucose Test Strips
Date Prepared:	June 30, 2005

Description of the Device:

Intended Use of the Device:

The FreeStyle Connect Blood Glucose Monitoring System is intended for invitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

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Image /page/1/Picture/0 description: The image shows the word "ABBOTT" in a bold, sans-serif font. To the left of the word is a stylized "a" symbol, also in bold. The text and symbol are black against a white background.

	Predicate Devices	Subject (modified)Device
Company	Abbott Laboratories	Same
Division	Abbott Diabetes Care	Same
510(k) Reference	K022941 and K050500	Current Submission
Proprietary Name:	Precision PCx Point of Care Monitorand FreeStyle 600 Blood Glucose TestStrips	Same
Common Name:	Blood Glucose Monitor and ReagentTest Strips	Same
Classification Number:	21 CFR §862.1345	Same
Intended Use	Quantitative measurement of bloodglucose concentrations	Same
Single Use?	Yes, test strips are single use	Same
Sterilized?	No	Same

Comparison to Predicate Device:

Performance Studies:

The performance of the FreeStyle Connect BGMS was studied in the laboratory. The results obtained during these studies demonstrated that the FreeStyle Connect BGMS is substantially equivalent to the predicate devices.

Conclusion:

Results of laboratory testing demonstrated that the performance of the FreeStyle Connect BGMS is acceptable and comparable to the performance of the predicate devices for blood glucose testing when used according to its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of an abstract human figure with three flowing lines representing the body. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the top and left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kimberly Kline Senior Regulatory Associate Abbott Laboratories Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502

AUG 9 - 2005

Re: K051802

Trade/Device Name: FreeStyle Connect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 29, 2005 Received: August 1, 2005

Dear Ms. Kline:

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 either class II (Special Controls) or class III (PMA), 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 cormply 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Satz

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

FreeStyle Connect™ Blood Glucose Monitoring System Device Name:

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter × Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051802

f Page 1 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.