FASTTAKE ADAPTER, MODEL # P/N 020-072-01

K983468 · Selfcare, Inc. · JQP · Dec 17, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983468
• Device Name: FASTTAKE ADAPTER, MODEL # P/N 020-072-01
• Applicant: Selfcare, Inc.
• Product Code: JQP · Clinical Chemistry
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2100
• Device Class: Class 1

Intended 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.

Device Story

FastTake Adapter acts as communication bridge between FastTake Blood Glucose Meter and personal computer; requires external ONE TOUCH interface cable. Device facilitates data transfer from meter to PC for management of glucose readings. Used in home or clinical settings by patients or healthcare providers. Operates as microprocessor-controlled communication module. Enables digital record-keeping and analysis of blood glucose data on external computer systems.

Clinical Evidence

Bench testing only. Software and hardware verification and validation tests were performed to demonstrate reliable communication between the PC and the FastTake Blood Glucose Meter.

Technological Characteristics

Microprocessor-controlled communication device. Functions as a data processing module/accessory. Connectivity via interface cable to glucose meter and PC. Class I device.

Indications for Use

Indicated for use as an accessory to the FastTake Blood Glucose Meter to facilitate data transfer between the meter and a personal computer. Intended for use by patients or clinicians in home or clinical settings.

Regulatory Classification

Identification

A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.

Predicate Devices

• Precision Link™ Communications Box (K952279)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone]

#### Contact Person:

Betty Lane Phone [phone] 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.

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#### 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.

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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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#### Page 2

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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## 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.

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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