510(k) · Cleared
ClearedOSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SEKISUI Diagnostics, LLC · KTN System, Test, Infectious Mononucleosis
Cleared on Jun 22, 2018 as substantially equivalent to K972231 (Wyntek Diagnostics, Inc., 1997) after a 21-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jun 22, 2018
- Review
- 21 days
- Class
- Class II
- Product code
- KTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972231 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972231 Osom Mono Test 143Wyntek Diagnostics, Inc. · 1997
- This deviceK181436 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono…SEKISUI Diagnostics, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972231 | Osom Mono Test 143 | Wyntek Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health… | SEKISUI Diagnostics, LLC | 2018 | — |
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 |
|---|---|---|---|
| * | K972231 | Osom Mono Test 143Summary page 4…se antibodies aid in the diagnosis of infectious mononucleosis IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICES [807.92(A)(3)] Sekisui Diagnostics OSOM Mono Test, K972231 DESCRIPTION OF DEVICE [807.92 (A)(4)] The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine eryt… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K972231.
How does its category compare?
All KTN devicesKTN System, Test, Infectious Mononucleosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181436: OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181436
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026