510(k) · Cleared
Recalled · Class III · 2016Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · KTN System, Test, Infectious Mononucleosis
Cleared on Feb 28, 2005 after a 189-day review. The FDA summary names its predicate without a number. It has been recalled 8 times.
- Decided
- Feb 28, 2005
- Review
- 189 days
- Class
- Class II
- Product code
- KTN
- Recalls
- 8
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Genzyme OSOM® Mono Test Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2016 | Class III | Z-2266-2016 | Unknown/Undetermined by firm | 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 | Unknown/Undetermined by firm | 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 | Unknown/Undetermined by firm | 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 | Unknown/Undetermined by firm | 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 | Unknown/Undetermined by firm | 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 | Unknown/Undetermined by firm | 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 | Unknown/Undetermined by firm | 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 | Material/Component Contamination | Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KTN devicesKTN System, Test, Infectious Mononucleosis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTN
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KTN
Too few KTN 510(k)s in any year since 2007 to give a median.
Recalls per year · KTN
No recall names KTN since 2007.
Adverse event reports per year · KTN
1in 2024
MAUDE reports naming product code KTN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042272: Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042272
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026