# K042272: Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Feb 28, 2005 after 189 days
- Product code: KTN (System, Test, Infectious Mononucleosis)
- Device class: 2
- Regulation: 21 CFR 866.5640
- Recalls of this device: 8 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Genzyme OSOM® Mono Test: named in the summary without a submission number

## Recalls of this device
- Jun 22, 2016 · Class III · Z-2266-2016: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- Jun 22, 2016 · Class III · Z-2270-2016: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- Jun 22, 2016 · Class III · Z-2271-2016: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- Jun 22, 2016 · Class III · Z-2269-2016: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- Jun 22, 2016 · Class III · Z-2265-2016: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- Jun 22, 2016 · Class III · Z-2268-2016: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- Jun 22, 2016 · Class III · Z-2267-2016: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- Feb 26, 2013 · Class III · Z-1148-2013: Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.

## Indications for use
The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies specific to infectious Mononucleosis in human whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for healthcare professionals including professionals at point-of-care sites.

Source page: https://510kreport.com/device/K042272
Methodology: https://510kreport.com/methodology