LXN FRUCTOSAMINE TEST SYSTEM

K962597 · Lxn Corp. · LCP · Jun 13, 1997 · Hematology

Device Facts

• Record ID: K962597
• Device Name: LXN FRUCTOSAMINE TEST SYSTEM
• Applicant: Lxn Corp.
• Product Code: LCP · Hematology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The LXN™ Fructosamine Test System is a device intended to measure fructosamine quantitatively in blood. The LXN™ Fructosamine Test System is intended for use by diabetics to monitor their blood fructosamine levels in a home use setting.

Device Story

LXN Fructosamine Test System measures fructosamine levels in blood; intended for home use by diabetic patients for monitoring. Device provides quantitative results to assist in glycemic control management. Operation involves blood sample application to test system; system processes sample to yield fructosamine concentration. Healthcare providers use output to assess patient's short-term glycemic status, aiding in diabetes management decisions. Benefits include patient empowerment through self-monitoring of blood fructosamine.

Technological Characteristics

In vitro diagnostic test system for quantitative measurement of fructosamine in blood. Designed for home use.

Indications for Use

Indicated for use by diabetic patients to quantitatively monitor blood fructosamine levels in a home setting.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Vivian T. Noetzel
Vice President
LXN Corporation
5830 Oberlin Drive, Suite 102
San Diego, California 92121

Re: K962597
LXN Fructosamine Test System
Regulatory Class: II
Product Code: LCP
Dated: June 3, 1997
Received: June 5, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

JUN 13 1997

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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/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known): K962597

Device Name: LXN Fructosamine Test System

Indications For Use:

## Indications for Use

The LXN™ Fructosamine Test System is a device intended to measure fructosamine quantitatively in blood.

## Intended Use

- The LXN™ Fructosamine Test System is intended for use by diabetics to monitor their blood fructosamine levels in a home use setting.


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Concurrence of the CDRH, Office of the Device Evaluation

Prescription Use ☐ OR Over-The-Counter

Use ☐

(Per 21 CFR 801.109)

(Optional Format 1-2-96)