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, focusing on the acceptance criteria and study data for the FastTake® Compact Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating equivalence to a predicate device, rather than explicit pre-defined "acceptance criteria" for performance. However, based on the Summary of Performance Data provided, we can infer the key performance metrics evaluated and their reported results. The predicate device's performance would serve as the implicit acceptance benchmark.

Performance Metric	Implied Acceptance Criteria (relative to predicate)	Reported Device Performance (Modified FastTake®)
Precision	Demonstrates equivalent or better precision at various glucose levels.	Glucose Level 1 (62 mg/dL): SD=1.1 mg/dL, CV=1.7%Glucose Level 2 (87 mg/dL): SD=3.5 mg/dL, CV=4.0%Glucose Level 3 (152 mg/dL): SD=3.2 mg/dL, CV=2.1%Glucose Level 4 (220 mg/dL): SD=6.3 mg/dL, CV=2.9%Glucose Level 5 (378 mg/dL): SD=9.1 mg/dL, CV=2.4%(Compared to unmodified FastTake®, indicating equivalence)
Accuracy (Professional Users vs. YSI)	Equivalent accuracy as measured against a reference method (YSI)	n = 238$y = 1.04x - 9.2$r = 0.988Sy·x = 13.5Range = 44 to 425 mg/dL
Accuracy (Lay Users vs. YSI)	Equivalent accuracy as measured against a reference method (YSI)	n = 119$y = 1.03x - 5.2$r = 0.982Sy·x = 16.69Range = 46 to 425 mg/dL

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

Precision Study (Laboratory Study):
- Sample Size: 20 samples (n=20) for each of the 5 glucose levels.
- Data Provenance: The document states "A laboratory study," implying an in-house or controlled laboratory setting. It does not specify the country of origin or whether it's retrospective or prospective, but such laboratory studies are typically prospective.
Accuracy Study (Clinical Centers):
- Professional Users: n = 238.
- Lay Users: n = 119.
- Data Provenance: "clinical centers" (plural, suggesting multiple sites). The context implies these are prospective clinical studies. The country of origin is not explicitly stated, but the submission is to the US FDA, making it highly probable the studies were conducted in the US or under US regulatory standards. The participants were "people with diabetes."

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

This type of device (blood glucose monitor) does not typically rely on human expert interpretation for ground truth. The gold standard for glucose measurement is usually a highly accurate laboratory reference method.

Ground Truth Method: The text explicitly states "Accuracy of Professional users compared to YSI" and "Accuracy of Lay users compared to YSI." YSI (Yellow Springs Instruments) is a well-known brand for laboratory-grade glucose analyzers, serving as the reference method or "ground truth" in these studies.
Number/Qualifications of Experts: Not applicable, as the ground truth was established by laboratory instrumentation (YSI), not human experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used when human experts are establishing ground truth, especially for subjective assessments (e.g., image interpretation). Since the ground truth was instrumental (YSI), no human adjudication method was needed or performed.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is relevant for diagnostic imaging AI devices where human interpretation is a primary component. For a blood glucose monitor, the focus is on the device's direct measurement capability, both by professional and lay users, against a laboratory reference.

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

Yes, implicitly. The performance data presented (precision and accuracy) represents the device's performance. While "lay users" and "professional users" are involved in operating the device, the metrics themselves ($y=mx+b$, r-value, S_yx, SD, CV%) are a standalone reflection of the device's measurement precision and accuracy compared to a reference standard (YSI). There isn't a separate "algorithm" being evaluated beyond the functioning of the glucose meter and test strips.

7. The Type of Ground Truth Used

The ground truth used was an objective laboratory reference method, specifically a YSI glucose analyzer. This is considered a highly accurate and precise instrumental measurement, often serving as the gold standard for glucose concentration.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device development or performance evaluation. Blood glucose monitoring systems typically do not involve machine learning algorithms that require separate training sets in the way AI/ML medical devices do. The performance data presented is from verification and validation studies on the final product.

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

Not applicable, as there is no mention or indication of a training set as understood in AI/ML development. The ground truth for the performance studies was established by a laboratory reference instrument (YSI).

Summary

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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 (781) 647-3939 Fax:

Contact Person:

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

Summary Prepared:

October 22, 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 is being modified to change the blood application method from top-fill to top-edge fill.

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 K990939. Both the modified and unmodified FastTake® Blood Glucose Monitoring Systems were developed and are controlled Selfcare, Inc. in Waltham, MA and its subsidiaries. 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 K990939.

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:

Laboratory and clinical studies demonstrate that the modified FastTake® Blood Glucose Test Strips provides equivalent performance to the unmodified FastTake® Blood Glucose Test Strips.

Precision: A laboratory study of 20 samples (n=20), using modified FastTake Blood Glucose Test Strips to test whole blood samples at 5 different glucose levels (Glucose Level), showed the following performance:

Glucoselevel	N	meanmg/dL	SDmg/dL	CV%
1	20	62	1.1	1.7
2	20	87	3.5	4.0
3	20	152	3.2	2.1
4	20	220	6.3	2.9
5	20	378	9.1	2.4

Precision

Accuracy

Accuracy of Professional userscompared to YSI using capillarywhole blood on 125 people withdiabetes at three clinical centers	n = 238$y = 1.04x - 9.2$r = 0.988Sy·x = 13.5Range = 44 to 425 mg/dL
Accuracy of Lay users comparedto YSI using capillary wholeblood on 125 people with diabetesat three clinical centers	n = 119$y = 1.03x - 5.2$r = 0.982Sy·x = 16.69Range = 46 to 425 mg/dL

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 2 1999

Ms. Carol Adiletto, M.S. Director of Clinical Affairs Selfcare, Inc. 200 Prospect Street Waltham, Massachusetts 02154-3457

Re: K993632

Trade Name: FastTake® Compact Blood Glucose Monitoring System Regulatory Class: II Product Code: CGA Dated: October 26, 1999 Received: October 27, 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 (OS) 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/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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Section 4 Labeling and "Indications for Use" Statement

4.1 ODE INDICATIONS STATEMENT

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

FastTake® Compact Blood Glucose Monitoring System Device Name:

Indications for Use:

Sean Cooper

ASE 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 {

Section 4

510(k) Notification FastTake® Modification

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.