TOUCH TEAR IGE MICROASSAY KIT

• K Number: K991316
• Device Name: TOUCH TEAR IGE MICROASSAY KIT
• Manufacturer: TOUCH SCIENTIFIC, INC.
• Date Cleared: 1999-08-09 ( 112 days)
• Product Code: DGC
• Regulation Number: 866.5510
• Type: Traditional
• Panel: Immunology
• Reference & Predicate Devices: N/A
• Predicate For: K083184

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 Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Touch Tear IgE Microassay Kit." It establishes substantial equivalence to a predicate device and provides regulatory information. However, it does not contain the detailed study information, acceptance criteria, or performance data that would be used to describe the acceptance criteria and the study that proves the device meets them, as requested in your prompt.

The document states: "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 (...) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This indicates that the device was cleared based on demonstrating equivalence, not necessarily on a novel clinical study with specific acceptance criteria that are detailed in this letter.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not present any performance data or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is an in vitro diagnostic kit, not an AI algorithm.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Conclusion: The provided document is a regulatory clearance letter and does not contain the technical study details, acceptance criteria, or performance data required to answer your prompt. To get this information, you would need to refer to the actual 510(k) submission documentation, which is generally more extensive and includes the study reports.

Summary

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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 ✓

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).