(16 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is intended for "in vitro diagnostic use" and functions as an "aid to monitor the effectiveness of diabetes control," which are characteristics of a diagnostic device.
No
The device description explicitly lists hardware components: Test Strips, Compact Blood Glucose Meter, Control Solution, and lancing device/lancets. This indicates it is a hardware-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The FastTake® Compact Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use)..."
This statement directly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
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.
Product codes
CGA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by diabetics at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
| Glucose level | N | mean mg/dL | SD mg/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 |
Accuracy of Professional users compared to YSI using capillary whole blood on 125 people with diabetes at three clinical centers: n = 238, y = 1.04x - 9.2, r = 0.988, Sy·x = 13.5, Range = 44 to 425 mg/dL
Accuracy of Lay users compared to YSI using capillary whole blood on 125 people with diabetes at three clinical centers: n = 119, y = 1.03x - 5.2, r = 0.982, Sy·x = 16.69, Range = 46 to 425 mg/dL
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
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:
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:
| Glucose
level | N | mean
mg/dL | SD
mg/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 users
compared to YSI using capillary
whole blood on 125 people with
diabetes at three clinical centers | n = 238
$y = 1.04x - 9.2$
r = 0.988
Sy·x = 13.5
Range = 44 to 425 mg/dL |
|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Accuracy of Lay users compared
to YSI using capillary whole
blood on 125 people with diabetes
at three clinical centers | n = 119
$y = 1.03x - 5.2$
r = 0.982
Sy·x = 16.69
Range = 46 to 425 mg/dL |
2
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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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
4
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:
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.
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