GO GLUCOSE MONITORING SYSTEM

K991754 · Lxn Corp. · CGA · Sep 8, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991754
• Device Name: GO GLUCOSE MONITORING SYSTEM
• Applicant: Lxn Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The GO Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose in whole blood specimens. The GO Glucose Monitoring System is intended for use by people with diabetes to monitor their blood glucose levels in a home use setting. This in vitro test kit is indicated for home use (over the counter).

Device Story

GO Glucose Monitoring System; in vitro diagnostic test kit for quantitative, colorimetric determination of glucose in whole blood. Designed for home use by patients with diabetes to monitor blood glucose levels. System utilizes colorimetric chemistry to measure glucose concentration; provides numerical blood glucose output to user. Enables patient self-management of diabetes through regular monitoring.

Technological Characteristics

In vitro diagnostic test kit; colorimetric glucose determination; whole blood specimen analysis; home-use form factor.

Indications for Use

Indicated for individuals with diabetes for monitoring blood glucose levels in a home setting using whole blood specimens.

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 8 1999

Ms. Neda Rashti Director of Clinicals and Regulatory Affairs LXN Corporation 6325 Lusk Boulevard San Diego, California 92121

- Re: K991754
Trade Name: GO Glucose Monitoring System Regulatory Class: II Product Code: CGA Dated: August 2, 1999 Received: August 4, 1999

Dear Ms. Rashti:

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 (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 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 [phone].

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 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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Attachment 1

## INTENDED USE STATEMENT

K991754 510(k) Number:

Device Name: GO Glucose Monitoring System

The GO Glucose Monitoring System is intended for the Intended Use: quantitative, colorimetric determination of glucose in whole blood specimens.

- The GO Glucose Monitoring System is intended for use by people Indication for Use: with diabetes to monitor their blood glucose levels in a home use setting. This in vitro test kit is indicated for home use (over the counter).
Scam Cogn

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vision of Clinical Laboratory Devices
K 991754
ROKE Number.

(PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of the CDRH, Office of the Device Evaluation

Prescription Use ﺮﺍﻧﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ

(Per 21 CFR 801.109)