# K030215: Biorapid Mononucleosis

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 24, 2003 after 34 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 K972231 (1997). 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)
- K972231: Osom Mono Test 143, Wyntek Diagnostics, Inc. (1997)

## Indications for use
biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis.

Source page: https://510kreport.com/device/K030215
Methodology: https://510kreport.com/methodology