The FastTake® Compact Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The FastTake® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

Device Description

The FastTake® system includes four main components:

· FastTake® Test Strips
FastTake® Compact Blood Glucose Meter .
· FastTake® Control Solution
· Penlet II or Penlet Plus lancing device and FinePoint lancets.

AI/ML Overview

Here's an analysis of the provided text regarding the FastTake® Compact Blood Glucose Monitoring System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Visual confirmation of sufficient blood sample on test strip	Patients detected under-filled and correctly filled strips with 99% accuracy.
Ability of intended users (diabetic patients) to utilize the new feature independently	Demonstrated ability of individual patients to test independently.
Equivalence in performance to the unmodified predicate device	Verification and validation tests demonstrate that the modified system has equivalent performance to the unmodified FastTake Compact Blood Glucose Monitoring System.

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

Sample Size: 19 diabetic patients.
Data Provenance: The study was a "consumer-use study," implying real-world or simulated home use. The location/country of origin is not explicitly stated, but Selfcare, Inc. is located in Waltham, MA, USA, suggesting a US-based study. It was a prospective study as it evaluated users interactively with the device feature.

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

This information is not provided in the given text. The study focused on consumer perception and ability to detect correct filling, implying the "ground truth" for the confirmation window's effectiveness was based on the physical state of the strip (correctly filled vs. under-filled), which would likely be objectively observable or determined by the study administrators rather than expert consensus on a diagnosis.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the "ground truth" likely related to objective observation of the test strip filling, a formal adjudication method like 2+1 or 3+1 might not have been necessary for this specific performance metric.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study was a consumer-use study to evaluate the usability and effectiveness of a visual confirmation window, not a comparison of human reader performance with and without AI assistance for diagnosis.

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

This device, a blood glucose monitoring system, is a diagnostic device that requires human interaction (applying blood to the strip). There is no mention of a standalone algorithm-only performance study independent of human use for the FastTake® Compact Blood Glucose Monitoring System as described. The "confirmation window" is a visual aid for the user, not an automated algorithm to interpret results.

7. The Type of Ground Truth Used

The ground truth for the consumer-use study regarding the confirmation window was based on the adequacy of sample filling (i.e., whether the strip was correctly filled or under-filled). This is an objective characteristic of the test strip's physical state rather than a medical diagnosis.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is not an AI/ML-based system requiring a training set in the typical sense. The "FastTake® strips with the new confirmation window feature" were evaluated, implying a design change rather than a learned model.

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

This information is not applicable as there is no training set for an AI/ML model for this device.

Summary

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K 990935

Section 10 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

Carol A. Adiletto Director of Clinical Affairs Selfcare, Inc. 200 Prospect Street Waltham, MA 02453-3457 USA Phone: (781) 647-3900 Fax: (781) 647-3939

Contact Person:

Carol A. Adiletto Phone (781) 647-3900 x124

Summary Prepared:

March 19, 1999

Name of the device:

FastTake® Compact Blood Glucose Monitoring System

Classification name(s):

The FastTake® Compact Blood Glucose Monitoring System is classified as a Class II device (21 CFR § 862.2100). It is for home use.

Classification of predicate device(s):

The FastTake® test strip of the FastTake® Compact Blood Glucose Monitoring System is being modified to provide a visual confirmation window to provide the user with a way of ensuring that sufficient blood has been applied to the test strip.

The FastTake® Compact Blood Glucose Monitoring System which is not materially different from the predicate device, FastTake® Compact Blood Glucose Monitoring System, was cleared for use in the United States as the Elect II Blood Glucose Monitoring System by K970707. Both the modified and unmodified FastTake® Blood Glucose Monitoring Systems were developed and are controlled Selfcare, Inc. in Waltham, MA. LifeScan, Inc. of Milpitas, CA distributes the FastTake® Compact Blood Glucose Monitoring System.

Description of the device

The FastTake® system includes four main components:

· FastTake® Test Strips
FastTake® Compact Blood Glucose Meter .
· FastTake® Control Solution
· Penlet II or Penlet Plus lancing device and FinePoint lancets.

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Intended use(s):

The Intended Use of the FastTake® Compact Blood Glucose Monitoring System is the same as the device that was cleared by K970707.

The FastTake Compact Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The FastTake® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

Statement of How the Technological Characteristics of the Device Compare to the Predicate device:

The technological characteristics of the modified FastTake® Compact Blood Glucose Monitoring System are the same as the legally marketed predicate device (unmodified FastTake® Compact Blood Glucose Monitoring System).

Summary of Performance Data:

Verification and validation tests demonstrate that modified FastTake® Compact Blood Glucose Monitoring System has equivalent performance to the unmodified FastTake Compact Blood Glucose Monitoring System.

The FastTake® strips with the new confirmation window feature were evaluated in a consumer-use study by 19 diabetic patients who ranged in age from 3 to 54.

The results of this study indicate that typical intended users (i.e. people with diabetes) can use the new FastTake® strips' confirmation window to view sample filling adequacy. The data showed that the patients detected under-filled and correctly filled strips with 99% accuracy. The ability of individual patients to test independently was also demonstrated.

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Public Health Service

Image /page/2/Picture/2 description: The image shows a black and white logo. The logo consists of a stylized depiction of an eagle's head and neck. The eagle's head is facing to the right, and its neck is curved. The logo is simple and modern, and it is likely used to represent a government agency or organization.

APR 2 0 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Carol A. Adiletto Director of Clinical Affairs Selfcare, Inc. 200 Prospect Street Waltham, MA 02453-3457

Re: K990939

Trade Name: FastTake® Compact Blood Monitoring System Requlatory Class: II Product Code: CGA Dated: March 19, 1999 Received: March 22, 1999

Dear Ms. Adiletto:

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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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/dsmamain.html".

Sincerely yours,

Steven Sutman

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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Section 4 Labeling and "Indications for Use" Statement

4.1 ODE INDICATIONS STATEMENT

Indications for Use Statement

510(k) Number (if known): _ K 990939

FastTake® Compact Blood Glucose Monitoring System Device Name:

Indications for Use:

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K990939

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.019) OR

Over-The-Counter Use

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.