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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
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

§ 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).