(77 days)
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No
The document describes a simple data transfer accessory and makes no mention of AI, ML, or any related concepts.
No
The device is described as an "accessory" that provides a "communication link" for "data transfer" between a blood glucose meter and a personal computer. It does not directly perform any therapeutic action.
No
The device is an adapter for data transfer from a blood glucose meter to a computer; it does not perform any diagnostic function itself. The diagnostic function is performed by the blood glucose meter.
No
The device is described as an "Adapter" and mentions "hardware verification and validation tests," indicating it is a physical component, not solely software.
Based on the provided text, the Lifescan FastTake® Adapter is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- Intended Use: Its intended use is solely for data transfer between a blood glucose meter and a personal computer. It does not perform any diagnostic testing or analysis of biological samples.
- Device Description: It is described as an accessory that provides a communication link. It doesn't interact directly with blood or perform any chemical or biological reactions.
- Classification: It is classified as a calculator/data processing module for clinical use (21 CFR § 862.2100). This classification falls under general clinical devices, not specifically IVDs.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, performing diagnostic tests, or providing diagnostic information.
While it is an accessory to a blood glucose meter (which is an IVD), the adapter itself is a data transfer device and not an IVD.
N/A
Intended Use / Indications for Use
The FastTake" Adapter is an accessory to the FastTake Blood Glucose Meter. lt provides a communication link between the FastTake Meter and the ONE TOUCH® cable, neither of which is included with the Adapter. The FastTake Adapter is intended to be used for data transfer between a FastTake Meter and a personal computer.
The Lifescan FastTake® Adapter is an accessory to the Lifescan FastTake® Blood Glucose Meter. It provides a communication link between the FastTake® Meter and the Lifescan ONE TOUCH® Interface cable, neither of which is included. The FastTake Adapter is intended to be used for data transfer between a FastTake® Meter and a personal computer.
Product codes
JQP
Device Description
The FastTake Adapter is a Class I accessory device classified as a calculator/data processing module for clinical use (21 CFR § 862.2100). As it can also be used in the home by a layperson, it is not exempt from premarket notification (21 CFR § 862.9(a)). The FastTake" Adapter is an accessory to the FastTake Blood Glucose Meter. lt provides a communication link between the FastTake Meter and the ONE TOUCH® cable, neither of which is included with the Adapter. The FastTake Adapter is intended to be used for data transfer between a FastTake Meter and a personal computer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
As it can also be used in the home by a layperson.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software and hardware verification and validation tests demonstrate that the FastTake Adapter provides reliable communication between a PC and the FastTake Blood Glucose Meter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2100 Calculator/data processing module for clinical use.
(a)
Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
1983468
DEC 17 1998
Section 5 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Betty J. Lane Director of Quality and Regulatory Affairs Selfcare, Inc. 200 Prospect Street Waltham, MA 02453-3457 USA Phone: (781) 647-3900 Fax: (781) 647-3939
Contact Person:
Betty Lane Phone (781) 647-3900 x144
Summary Prepared:
September 30, 1998
Name of the device:
FastTake® Adapter
Classification name(s):
The FastTake Adapter is a Class I accessory device classified as a calculator/data processing module for clinical use (21 CFR § 862.2100). As it can also be used in the home by a layperson, it is not exempt from premarket notification (21 CFR § 862.9(a)).
Classification of predicate device(s):
The FastTake Adapter is not materially different from the predicate device, the Precision Link™ Communications Box, a component of the Precision Link™ Blood Glucose Data Management System. The predicate device is manufactured by Medisense, Inc and was cleared for use in the United States by K952279. The Precision Link™ System, which is classified as a data management system, is comprised of five separate components: data management software, communications box, an AC power adapter, communications cable, and an RS-232 cable. It is the Precision Link™ Communications Box that the FastTake Adapter is analogous to. Whereas K952279 covered all components of the Precision Link™ Data Management System, this premarket notification covers only the communication link component (i.e. the FastTake Adapter).
Description of the device/intended use(s):
The FastTake" Adapter is an accessory to the FastTake Blood Glucose Meter. lt provides a communication link between the FastTake Meter and the ONE TOUCH® cable, neither of which is included with the Adapter. The FastTake Adapter is intended to be used for data transfer between a FastTake Meter and a personal computer.
1
Statement of How the Technological Characteristics of the Device Compare to the Predicate device:
The technological characteristics are the same as both devices are micoprocessor controlled communication devices, thus have the same safety and effectiveness. They have the same intended use, i.e. communication between a PC and a glucose meter.
Summary of Performance Data:
Software and hardware verification and validation tests demonstrate that the FastTake Adapter provides reliable communication between a PC and the FastTake Blood Glucose Meter.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting hair or movement.
DEC 17 1998
Ms. Betty J. Lane Director of Quality and Requlatory Affairs Selfcare, Inc. 200 Prospect Street Waltham, Massachusetts 02453-3457
Re : K983468 FastTake® Adapter Trade Name: Requlatory Class: I Product Code: JQP Dated: September 30, 1998 Received: October 1, 1998
Dear Ms. Lane:
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 Requlations, 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 Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 Butman
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
Indications for Use Statement
510(k) Number (if known): K983468
Lifescan FastTake® Adapter Device Name:
Indications for Use:
The Lifescan FastTake® Adapter is an accessory to the Lifescan FastTake® Blood Glucose Meter. It provides a communication link between the FastTake® Meter and the Lifescan ONE TOUCH® Interface cable, neither of which is included. The FastTake Adapter is intended to be used for data transfer between a FastTake® Meter and a personal computer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983468
Prescription Use (Per 21 CFR 801.019) OR
Over-The-Counter Use ✓
51.0(k) Notification FastTake Adapter