510(k) · Cleared
ClearedTriage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB Control, Triage Myoglobin Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · JJT Enzyme Controls (Assayed And Unassayed)
Cleared on Dec 10, 1997 after a 15-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 10, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- JJT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK974461 Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB…Biosite Incorporated · 1997
- Descendant · cites it directly · 3 of its ownK030089 Triage Cardiac Controls; Triage Cardio Profiler ControlsBiosite Incorporated · 2003
- Descendant · 2 generations on · 2 of its ownK040459 Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification…Biosite Incorporated · 2004
- Descendant · 3 generations on · 1 of its ownK072892 Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 2007 · Recalled
- Descendant · 4 generations on · 0 of its ownK093032 Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009
Most influential descendants
Showing 4 of 4 · See all- K030089Triage Cardiac Controls; Triage Cardio Profiler ControlsBiosite Incorporated · 2003 · cites it directly3descendants
- K040459Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification ControlsBiosite Incorporated · 2004 · 2 generations on2descendants
- K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 2007 · 3 generations on1descendant
- K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974461 | Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB Control… | Biosite Incorporated | 1997 | — |
| +1 | K030089 | Triage Cardiac Controls; Triage Cardio Profiler Controls | Biosite Incorporated | 2003 | — |
| +2 | K040459 | Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls | Biosite Incorporated | 2004 | — |
| +3 | K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5 | Biosite Incorporated | 2007 | 5 |
| +4 | K093032 | Triage Total 3 Controls and Calibration Verification Set | Biosite Incorporated | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJT? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030089 | Triage Cardiac Controls; Triage Cardio Profiler Controls | 2003 | 3 |
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, K030089 (Biosite Incorporated, 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JJT devicesJJT Enzyme Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJT
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · JJT
Too few JJT 510(k)s in any year since 2007 to give a median.
Recalls per year · JJT
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJT
1in 2011
MAUDE reports naming product code JJT, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K974461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974461: Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB Control, Triage Myoglobin Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974461
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026