510(k) · Cleared
ClearedOsom Mono Test 143
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wyntek Diagnostics, Inc. · KTN System, Test, Infectious Mononucleosis
Cleared on Aug 26, 1997 after a 71-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Aug 26, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- KTN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK972231 Osom Mono Test 143Wyntek Diagnostics, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK181436 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono…SEKISUI Diagnostics, LLC · 2018
- Descendant · cites it directly · 0 of its ownK030215 Biorapid MononucleosisInstrumentation Laboratory CO · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972231 | Osom Mono Test 143 | Wyntek Diagnostics, Inc. | 1997 | — |
| +1 | K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health… | SEKISUI Diagnostics, LLC | 2018 | — |
| +1 | K030215 | Biorapid Mononucleosis | Instrumentation Laboratory CO | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2018 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | — | MonoSpot Latex Test Named without a submission number | |
| * | — | CARDS OS Mono Test Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K181436 (SEKISUI Diagnostics, LLC, 2018) has gone furthest, with 0 descendants of its own.
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972231: Osom Mono Test 143.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972231
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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