PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM

K040628 · Abbott Laboratories · NBW · Mar 25, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040628
• Device Name: PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The revised Precision Link Diabetes Management System is a data management tool intended to collect and report information to assist with diabetes management.

Device Story

Precision Link Diabetes Management Software; data management tool for diabetes care. Inputs: blood glucose data from MediSense sensors via direct PC communication. Transformation: software processes, collects, and reports glucose data to assist clinical management. Used in clinical or home settings by patients or healthcare providers. Output: reports and data summaries for diabetes management decision-making. Modifications include OS updates, sensor compatibility, and improved PC connectivity.

Clinical Evidence

No clinical data. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of software modifications.

Technological Characteristics

Software-based data management system. Connectivity: PC-based interface for MediSense blood glucose sensors. Risk management per ISO 14971-1:1998(E).

Indications for Use

Indicated for people with diabetes and healthcare professionals to upload, view, analyze, and print blood glucose and blood ketone results from MediSense Products meters. Requires basic understanding of personal computers. Suitable for home and professional use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Precision Link® Blood Glucose Data Management System (K952279)

Submission Summary (Full Text)

{0}------------------------------------------------

MAR 2 5 2004

Image /page/0/Picture/2 description: The image shows the word "Medisense" in a bold, sans-serif font. A curved line extends from the top of the "M" to the top of the "e", creating a semi-circular shape above the word. A small asterisk symbol is located to the right of the "e".

K040628

# 510(k) Summary

(as required by 21 CFR 807.92)

- Submitted by: Graham A. L. Baillie Senior Requlatory Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730
- Device Name: Precision Link® Diabetes Data Management System
- Common Name: Data Management System (Accessory to Blood Glucose Testing System)
- Classification: Glucose Test System Class II per 21 CFR 862.1345
- Product Code: NBW
- Predicate Device: Precision Link® Blood Glucose Data Management System, K952279
- The Precision Link Diabetes Data Management System is a blood Description: glucose data management software system designed to operate on a Windows/Intel/IBM compatible platform.

Data is transferred from the glucose meter via a serial cable to a PC, then processed and presented in various user selected graphical formats. Precision Link is available for home and professional use.

- Intended Use: The Precision Link systems are intended to collect and report information to assist with diabetes management.
### Comparison to

- Predicate Device: The Precision Link Diabetes Data Management System uses the same fundamental scientific technology and has the same intended use as the predicate Precision Link Blood Glucose Data Management System, K952279.

{1}------------------------------------------------

| Performance<br>Studies: | System hardware and software verification testing confirms that the<br>modified Precision Link Diabetes Data Management System is<br>equivalent to the currently marketed Precision Link Blood Glucose<br>Data Management System. The changes have been verified and do<br>not adversely affect safety or effectiveness. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | System verification testing confirms that Precision Link will perform<br>as intended when used in accordance with device labeling. |
| Conclusion: | Test results demonstrate that the performance of the Precision Link<br>Diabetes Data Management System, when used according to the<br>intended use stated above, is acceptable and substantially<br>equivalent to the performance and safety characteristics of the<br>previously mentioned predicate device. |

:

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# MAR 2 5 2004

Mr. Graham A. L. Baillie Senior Regulatory Affairs Specialist Abbott Laboratories MediSense Products 4-A Crosby Drive Bedford, MA 01730

k040628 Re:

Ko40026
Trade/Device Name: Precision Link® Diabetes Data Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 9, 2004 Received: March 10, 2004

Dear Mr. Baillie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

#### Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the . Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Jean M. Cooper, US, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications For Use

510(k) Number:

K840428

Device Precision Link® Diabetes Data Management System Name:

#### Indications

The MediSense Precision Link® Diabetes Data Management System lets For Use: you view and analyze results of a MediSense Products meter. It enables the users to upload blood glucose and blood ketone results from a MediSense Products meter, view the information, and print the information using various report formats. Precision Link is designed for use by people with diabetes and/or healthcare professionals that have a basic understanding of personal computers

Prescription Use (per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter-Use × (21CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K040628