TOUCH TEAR IGE MICROASSAY KIT

K991316 · Touch Scientific, Inc. · DGC · Aug 9, 1999 · Immunology

Device Facts

• Record ID: K991316
• Device Name: TOUCH TEAR IGE MICROASSAY KIT
• Applicant: Touch Scientific, Inc.
• Product Code: DGC · Immunology
• Decision Date: Aug 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The TOUCH TEAR IGE MICROASSAY KIT™ is an in vitro diagnostic device which is used for the quantitative determination of Immunoglobulin E (IgE) concentration in human tears. This can be used as an aid in the diagnosis of ocular Type 1 allergic conjunctivitis or the allergic component of ocular inflammatory responses.

Device Story

In vitro diagnostic kit for quantitative measurement of IgE concentration in human tear samples. Used by clinical laboratory professionals to assist in diagnosing ocular Type 1 allergic conjunctivitis or allergic components of ocular inflammatory responses. Provides quantitative IgE levels to healthcare providers to support clinical assessment of allergic eye conditions.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic microassay kit for quantitative IgE determination. Specific materials, sensing principles, and software details are not described in the provided text.

Indications for Use

Indicated for quantitative determination of IgE in human tears to aid in diagnosis of ocular Type 1 allergic conjunctivitis or allergic component of ocular inflammatory responses.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Submission Summary (Full Text)

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AUG - 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Alan J. Touch Touch Scientific, Inc. 3209 Gresham Lake Road Suite 112 Raleigh, North Carolina 27615

Re: K991316 Trade Name: Touch Tear IgE Microassay Kit Regulatory Class: II Product Code: DGC Dated: July 20, 1999 Received: July 26, 1999

Dear Dr. Touch:

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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: K991316

Device Name: Touch Tree IgE MICROALsay Kit

Indications For Use: The TOUCH TEAR IGE MICROASSAY KIT™ is an *in vitro* diagnostic
device which is used for the quantitative determination of
Immunoglobulin E (IgE) concentration in human tears. This can be
used as an aid in the diagnosis of ocular Type 1 allergic conjunctivitis

or the allergic component of ocular inflammatory responses.

Rita E. Maker

(Division Sign-Off) Division of Clinical Laboratory Dev 510(k) Number

Prescription Use *✓*