# K981946: Clearview IM

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: Dec 10, 1998 after 190 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
Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis IgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.

Source page: https://510kreport.com/device/K981946
Methodology: https://510kreport.com/methodology