The FreeStyle™ Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

Device Description

The FreeStyle™ Lite Blood Glucose Monitoring System (BGMS) utilizes coulometric biosensor technology found in the FreeStyle Lite test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Lite 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 document describes a 510(k) premarket notification for the FreeStyle™ Lite Blood Glucose Monitoring System. It states that the device was studied in a laboratory and the results demonstrated substantial equivalence to a predicate device (FreeStyle Freedom™ Blood Glucose Monitoring System, K051839). However, it lacks detailed quantitative acceptance criteria and specific study results.

Here's an attempt to answer your questions based on the available information, noting where details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific reported device performance values. It generally claims the device is "acceptable and comparable" and achieved "substantial equivalence" to the predicate device.

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

The document states that the performance was "studied in the laboratory." It does not provide information on the sample size used for the test set (number of blood samples, number of participants), data provenance (country of origin), or whether the study was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for blood glucose measurements is typically established by laboratory reference methods, not subjective adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC study is not relevant for a blood glucose monitoring system, which provides a quantitative measurement rather than requiring interpretation by multiple readers. The document does not describe such a study.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

A blood glucose monitoring system inherently performs as a "standalone" device in the sense that the algorithm processes the blood sample and displays a glucose value without human intervention in the measurement process itself. The document describes laboratory testing of the system, which represents its standalone performance.

7. The Type of Ground Truth Used

While not explicitly stated, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer or equivalent). This method provides highly accurate and precise glucose measurements for comparison. The document mentions "laboratory testing," which implies comparison against such a reference.

8. The Sample Size for the Training Set

The document does not provide information about a training set size. For a biosensor of this type, the "training" (calibration) is often built into the manufacturing process of the test strips and meter, rather than requiring a separate "training set" like in machine learning models. If any internal calibration or validation involved a dataset, it is not disclosed here.

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

As no training set is described in the context of machine learning, this question is not directly applicable. If there were internal calibration processes, the ground truth for those would typically be established using highly accurate laboratory reference methods.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other. The text is in a bold, sans-serif font.

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

t (510) 749-5400 f (510) 864-4791

LO70850

APR 1 0 2007

510(k) Summary

Per 21 CFR §807.92

Date Prepared:	March 27, 2007
Company	Abbott Laboratories
Division	Abbott Diabetes Care Inc.
Street Address	1360 South Loop Road
City, State Zip	Alameda, CA 94502
Telephone No.	510-749-5400
Fax No.	510-864-4791
Contact Person:	Dhruma ShahTel No. 510-749-6475Fax No. 510-864-4791dhruma.shah@abbott.com
Proprietary Name:	FreeStyle™ Lite Blood Glucose Monitoring System
Common Name:	Blood Glucose Testing System, GlucoseDehydrogenase
Classification Name:	Glucose Test System (21 CFR §862.1345, Productcode NBW, LFR)
Predicate Device:	FreeStyle Freedom™ Blood Glucose MonitoringSystem (K051839)

Description of the Device:

Intended Use of the Device:

The FreeStyle Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

The FreeStyle Lite Blood Glucose Monitoring System is intended for use in the

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Image /page/1/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of two parts: a stylized letter 'A' on the left and the text 'Abbott Diabetes Care' on the right. The text is in a bold, sans-serif font, with 'Abbott' on the top line and 'Diabetes Care' on the bottom line.

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

t (510) 749-5400 f (510) 864-4791

quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

	Predicate Device(K051839)	Subject (modified)Device
Enzyme	PQQ dependent glucosedehydrogenase	Same
Reagent Form	Test Strip	Same
Analyte	D-Glucose	Same
Detection Method	Electrochemical-(Coulometric)	Same
RecommendedSample	Venous or capillary wholeblood	Same
Calibration	Manual calibration code entry	No manual calibration codeentry required
Minimum SampleSize	0.3 microliter (300 nanoliter)	Same
Measurement Range	20-500 mg/dL	Same
Measurement Time	5 seconds (average)	Same
Hematocrit Range	15% to 65%	Same
Humidity Range	5% to 90%	Same
OperatingTemperature Range	40°-104° F	Same
Monitor Memory	250 test results	400 test results
Day averages	14-day average	7-, 14- & 30-day averages
Date/Time	Yes	Same
Communication	Serial Port	Same
Power Source	3V Coin Cell Battery	Same

Comparison to Predicate Device:

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Image /page/2/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of the Abbott "A" symbol on the left, followed by the text "Abbott" on the top line and "Diabetes Care" on the bottom line. The text is in a sans-serif font and is black.

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

t (510) 749-5400 f (510) 864-4791

Assessment of Non-Clinical Performance Data:

The performance of the FreeStyle Lite Blood Glucose Monitoring System was studied in The results obtained during these studies demonstrated that the the laboratory. FreeStyle Lite Blood Glucose Monitoring System is substantially equivalent to the predicate device.

Conclusion:

Results of laboratory testing demonstrated that the performance of the FreeStyle™ Lite Blood Glucose Monitoring System is acceptable and comparable in terms of safety and effectiveness to the performance of the predicate device for blood glucose testing when used according to its intended use.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 0 2007

Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502-7000 ATTN: Dhruma Shah

Re: K070850

Trade/Device Name: FreeStyle™ Lite Blood Glucose Monitoring System Regulation Number: 21 CFR $862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 28, 2007 Received: March 29, 2007

Dear Ms. Shah:

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 comply 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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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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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 Statement

510(k) Number : (if known)

K070850

FreeStyle™ Lite Blood Glucose Monitoring System Device Name:

Indications for Use:

The FreeStyle™ Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 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)

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe

SIQ(2) K070850

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.