# K972231: Osom Mono Test 143

- Pathway: 510(k) (Traditional)
- Applicant: Wyntek Diagnostics, Inc.
- Decided: Aug 26, 1997 after 71 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MonoSpot Latex Test: named in the summary without a submission number
- (no number) CARDS OS Mono Test: named in the summary without a submission number

## Most influential descendants
- K181436: OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test (2018), 0 descendants of its own
- K030215: Biorapid Mononucleosis (2003), 0 descendants of its own

## Indications for use
The OSOM™ Mono Test is intended for the qualitative detection of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.

Source page: https://510kreport.com/device/K972231
Methodology: https://510kreport.com/methodology