DUET GLUCOSE CONTROL MONITORING SYSTEM

K973140 · Lxn Corp. · CGA · Oct 31, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973140
• Device Name: DUET GLUCOSE CONTROL MONITORING SYSTEM
• Applicant: Lxn Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

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

Device Story

The DUET Glucose Control Monitoring System is an in vitro diagnostic device for home use by patients with diabetes. It performs quantitative, colorimetric determination of glucose and fructosamine levels from whole blood specimens. The system provides patients with a method to monitor glycemic control outside of a clinical setting. The device processes blood samples to produce numerical glucose and fructosamine concentration readings, which the patient uses to manage their diabetes care.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic system utilizing colorimetric determination for glucose and fructosamine analysis in whole blood.

Indications for Use

Indicated for individuals with diabetes for the quantitative monitoring of blood glucose and fructosamine levels in whole blood specimens in a home-use setting.

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

## OCT 31 1997

Vivianne T. Noetzel . Vice President, Quality Assurance and Regulatory Affairs LXN Corporation 5830 Oberlin Drive, Suite 102 San Diego, California 92121

Re: K973140 DUET™ Glucose Control Monitoring System Requlatory Class: II Product Code: CGA, LCP Dated: August 17, 1997 Received: August 21, 1997

Dear Ms. Noetzel:

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 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 The general controls provisions of the Act 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. ਕੇ 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 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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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#### X. Intended Use Statement

510(k) Number (if known): K962597 Device Name: DUET Glucose Control Monitoring System

Indications For Use:

### Indications for Use

The DUETTM Glucose Control Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens.

### Intended Use

ייר - שירות מעולם - בינוע - בינק

The DUET Fructosamine Test System is intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This in vitro test kit is intended for home use (over the counter).

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

| | Concurrence of the CDRH, Office of the Device Evaluation | | |
|-------------------------|-----------------------------------------------------------------------|--------------------------|----|
| Prescription Use<br>Use | OR | Over-The-Counter | ✓ |
| (Per 21 CFR 801.109) | (Division Sign-Off)<br>Division or Clinical Laborato<br>510(k) Number | (Optional Format 1-2-96) | 24 |

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