# K972457: Monocol/Lex-IM Test

- Pathway: 510(k) (Traditional)
- Applicant: Immunostics Inc.,
- Decided: Dec 1, 1997 after 153 days
- Product code: KTN (System, Test, Infectious Mononucleosis)
- Device class: 2
- Regulation: 21 CFR 866.5640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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”.

Source page: https://510kreport.com/device/K972457
Methodology: https://510kreport.com/methodology