# K012901: Color-Monogen

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 27, 2001 after 29 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
Longest line of descent: 1 generation back to K861016 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861016: Gamma Slide Test for Infectious Mononucleosis, Gamma Biologicals, Inc. (1986) Summary page 1.

## Indications for use
Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids in the diagnosis of infectious mononucleosis.

Source page: https://510kreport.com/device/K012901
Methodology: https://510kreport.com/methodology