The TheraSense FreeStyle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh whole capillary blood. The FreeStyle System is intended for use outside the body (in vitro diagnostic use) by health care professionals and people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and it is not intended for use on neonates or with arterial blood samples.

The TheraSense Inc. FreeStyle™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh whole capillary blood. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The FreeStyle "" System is intended for use outside the body (in vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates (newborns) or arterial blood.

The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger or arm.

Device Description

The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet and a Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.

When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (beeps) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liquid crystal display (LCD).

AI/ML Overview

The provided document focuses on the FreeStyle™ Blood Glucose Monitoring System by TheraSense Inc. and details the submission for 510(k) clearance, claiming substantial equivalence to predicate devices. It describes the device's function and intended use, along with a summary of performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria (e.g., specific accuracy percentages, bias limits, or precision requirements) for the FreeStyle system. Instead, it refers to fulfilling general performance requirements and clinical acceptable accuracy based on a recognized method.

However, the reported device performance indicates it met these implicit criteria.

Acceptance Criteria (Implicit)	Reported Device Performance
Performance requirements outlined in FDA draft guidance "Review Criteria for Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology."	"Performance testing of the FreeStyle Blood Glucose Monitoring System demonstrated that the system meets the performance requirements for its intended use." "The results demonstrate that the FreeStyle Blood Glucose Monitoring System satisfies all performance requirements."
Clinical acceptable accuracy (likely referring to the Clarke Error Grid Analysis)	"When the blood glucose results were analyzed by the Clarke Error Grid Analysis, the System produced results within the range of clinical acceptable accuracy."
Equivalence to predicate device (FastTake)	"The data also demonstrate that the FreeStyle performs equivalently to the predicate device, FastTake."
Performance equivalence between lay user and trained technicians	"The data also demonstrate that the system performs equivalently in the hands of the lay user and a trained technician."
Correlation with laboratory reference method	"The clinical data demonstrate that the performance of FreeStyle correlates well with the laboratory method."

Note: The specific numerical targets for "clinical acceptable accuracy" or "performance requirements" are not detailed in this submission summary. These would typically be found in the full study report or the FDA guidance referenced.

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

Sample Size for Test Set: The document states "A multi-center controlled clinical study was conducted," but it does not specify the sample size (number of patients or samples) used for this clinical study.
Data Provenance: The study was a "multi-center controlled clinical study," implying prospective data collection across multiple sites. The document does not specify the country of origin of the data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The ground truth for the clinical study was established by a "standard laboratory test for measuring blood glucose."

Number of Experts: The document does not specify the number of experts (e.g., laboratory technicians, clinical chemists) involved in performing or interpreting the laboratory reference method.
Qualifications of Experts: The document implicitly suggests the reference method was performed by "experienced technicians" or qualified laboratory personnel, as it refers to a "standard laboratory test," but does not explicitly state their qualifications (e.g., "clinical pathologist with 15 years of experience").

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. The clinical study directly compared FreeStyle and the predicate device results to a "standard laboratory test" for ground truth.

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 is not applicable to this device. The FreeStyle Blood Glucose Monitoring System is an in vitro diagnostic device for quantitative glucose measurement, not an AI-assisted diagnostic imaging device requiring human reader interpretation or MRMC studies. The "human readers" in this context are lay users and trained technicians operating the device, and the comparison is between their use of the FreeStyle system versus a laboratory method and a predicate device.

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

This is not applicable in the AI sense. The FreeStyle system is a standalone device in that it provides a direct glucose reading from a blood sample without human interpretation of complex images or data beyond reading the displayed number. The performance study evaluated the device's accuracy in producing this reading, both in the hands of lay users and trained technicians, implying testing of the device as a standalone system.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was a "standard laboratory test for measuring blood glucose." This is a gold standard reference method for blood glucose concentration.

8. The Sample Size for the Training Set

The document does not mention a separate training set or its sample size. This is common for traditional medical devices where performance is typically established through analytical and clinical validation studies, rather than machine learning models that require distinct training and test sets.

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

Since a separate "training set" in the machine learning sense is not indicated or discussed, the method for establishing its ground truth is not applicable to this document. The ground truth for the overall performance evaluation was established by a "standard laboratory test for measuring blood glucose."

Summary

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TheraSense Inc.

K992684

JAN 1 4 2000

Image /page/0/Picture/4 description: The image shows the logo for TheraSense. The logo features a stylized human figure with outstretched arms, forming the letter 'S'. To the right of the figure is the word "THERASENSE" in bold, sans-serif font. Below the company name is the tagline "The Technology of Caring" in a smaller, italicized font.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is Not Assigned

1. Device Name

Classification Name:	Glucose Test System (§ 862.1345)
Common/Usual Name:	Blood Glucose Meter and Reagent Test Strips
Proprietary Names:	FreeStyle™ Blood Glucose Monitoring System

Legally Marketed Devices to which 2. Substantial Equivalence is Claimed:

Predicate Device	510(k) number
FastTake	K970707
Accu-Chek Advantage with Comfort Curve TestStrips	K930979 K980731 K982002
AtLast	K982076

3. Device Description

The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..

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TheraSense Inc.

Booklet and a Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.

4. Intended Use of the Device

5. Principle of Operation

The user obtains a blood sample using a conventional lancing technique on the finger or arm. The user inserts a test strip into the meter, which turns the meter on. When the strip is touched to the blood drop, the sample chamber on the strip fills by capillary action in approximately 2 seconds. The blood sample volume required is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger or other areas of the body such as the arm. Test results are displayed in about 15 seconds. The time required to display test results varies depending on the blood glucose concentration (approximately 15 to 45

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..

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seconds).

The glucose in the blood sample reacts with the glucose dehydrogenase enzyme to yield gluconolactone, and produces a small electrical current. This current is measured by the FreeStyle meter and displayed as a glucose level.

6. Summary of Data Demonstrating Substantial Equivalence

Performance testing of the FreeStyle Blood Glucose Monitoring System demonstrated that the system meets the performance requirements for its intended use. Laboratory testing was conducted in accordance with FDA draft guidance "Review Criteria for Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. The results demonstrate that the FreeStyle Blood Glucose Monitoring System satisfies all performance requirements.

A multi-center controlled clinical study was conducted to demonstrate accuracy and precision of the FreeStyle System when used by lay users with diabetes mellitus and by experienced technicians. Blood glucose results obtained with FreeStyle and with the predicate device, FastTake were compared to a standard laboratory test for measuring blood glucose.

The clinical data demonstrate that the performance of FreeStyle correlates well with the laboratory method. When the blood glucose results were analyzed by the Clarke Error Grid Analysis, the System produced results within the range of clinical acceptable accuracy. The data also demonstrate that the FreeStyle performs equivalently to the predicate device, FastTake. The data also demonstrate that the system performs equivalently in the hands of the lay user and a trained technician.

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7. Conclusions Drawn from Nonclinical and Clinical Tests

Laboratory and clinical studies demonstrate that the TheraSense FreeStyle Blood Glucose Monitoring System is equivalent to the FastTake Blood Glucose Monitoring System and is safe and effective for its intended use.

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..

000368

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2000

Eva A. Conner, Ph.D. Vice President, Ouality Assurance/Regulatory Affairs Therasense. Inc. 1360 South Loop Road Alameda, California 94502

Re: K992684

Trade Name: FreeStyle™ Blood Glucose Monitoring System Regulatory Class: II Product Code: LFR Dated: November 8, 1999 Received: November 9, 1999

Dear Dr. Connor:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: K992684

Device Name: FreeStyle™ Blood Glucose Monitoring System

Indications for Use:

The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger or arm.

Cospes
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992684

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Uses

unter Uses

(Per 21 CFR 801.109)

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.