510(k) · Cleared
ClearedColor-Monogen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · KTN System, Test, Infectious Mononucleosis
Cleared on Sep 27, 2001 as substantially equivalent to K861016 (Gamma Biologicals, Inc., 1986) after a 29-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Sep 27, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- KTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861016 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK861016 Gamma Slide Test for Infectious MononucleosisGamma Biologicals, Inc. · 1986
- This deviceK012901 Color-MonogenInstrumentation Laboratory CO · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861016 | Gamma Slide Test for Infectious Mononucleosis | Gamma Biologicals, Inc. | 1986 | — |
| 0 (this device) | K012901 | Color-Monogen | Instrumentation Laboratory CO | 2001 | — |
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 |
|---|---|---|---|
| * | K861016 | Gamma Slide Test for Infectious MononucleosisSummary page 1…ication name(s): 866.5640 Infectious Immunological Mononucleosis Test System Class I 82KTN System, Test, Infectious Mononucleosis Identification of predicate device(s): K861016 Sure-Vue™ Color Mono Description of the Device/Intended Use(s): Simple color-enhanced slide test for the qualitative and semiqu… | 1986 |
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.
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?
Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids 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/K012901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012901: Color-Monogen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012901
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026