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K Number
K972457
Device Name
MONOCOL/LEX-IM TEST
Manufacturer
IMMUNOSTICS, INC.
Date Cleared
1997-12-01

(153 days)

Product Code
KTN
Regulation Number
866.5640
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MONOCOL/LEX-IM TEST is a rapid color enhanced latex slide agglutination test for the qualitative and semiquantitative detection of heterophile antibodies in serum or plasma associated with infectious mononucleosis and is to be used as an aid in the diagnosis of infectious mononucleosis. This test is "For Professional Use Only".

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the MONOCOL/LEX-IM Test. While it grants market clearance, it does not contain the acceptance criteria or detailed study information required to answer your request.

Specifically, the letter 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 (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on substantial equivalence to a predicate device, not necessarily on a de novo study proving it met specific performance criteria detailed in this document. The letter itself is a regulatory approval, not a scientific report of the validation study.

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

  1. A table of acceptance criteria and the reported device performance: This information is not present in the clearance letter.
  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 their qualifications: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for imaging AI devices, and the MONOCOL/LEX-IM Test is a latex slide agglutination test.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a diagnostic test, not an AI algorithm.
  7. The type of ground truth used: Not mentioned.
  8. The sample size for the training set: Not applicable, as this is a chemistry/immunology test, not an AI model.
  9. How the ground truth for the training set was established: Not applicable.

To obtain this information, you would need to access the full 510(k) submission document for K972457, which often contains the clinical and analytical validation studies performed by the manufacturer. The clearance letter only confirms that the FDA reviewed these materials and found the device substantially equivalent.

§ 866.5640 Infectious mononucleosis immunological test system.

(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).