510(k) · Cleared
ClearedTriage Cardiac Controls; Triage Cardio Profiler Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 23, 2003 as substantially equivalent to K974461 (Biosite Incorporated, 1997) and 1 other predicate after a 13-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Jan 23, 2003
- Review
- 13 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974461 (1997). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974461 Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB…Biosite Incorporated · 1997
- This deviceK030089 Triage Cardiac Controls; Triage Cardio Profiler ControlsBiosite Incorporated · 2003
- Descendant · cites it directly · 2 of its ownK040459 Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification…Biosite Incorporated · 2004
- Descendant · 2 generations on · 1 of its ownK072892 Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 2007 · Recalled
- Descendant · 3 generations on · 0 of its ownK093032 Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009
Most influential descendants
Showing 3 of 3 · See all- K040459Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification ControlsBiosite Incorporated · 2004 · cites it directly2descendants
- K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 2007 · 2 generations on1descendant
- K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974461 | Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB Control… | Biosite Incorporated | 1997 | — |
| 0 (this device) | K030089 | Triage Cardiac Controls; Triage Cardio Profiler Controls | Biosite Incorporated | 2003 | — |
| +1 | K040459 | Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls | Biosite Incorporated | 2004 | — |
| +2 | K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5 | Biosite Incorporated | 2007 | 5 |
| +3 | K093032 | Triage Total 3 Controls and Calibration Verification Set | Biosite Incorporated | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 JJY? 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 |
|---|---|---|---|
| * | K974461 | Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB Control, Triage…Summary page 1…yed and Unassayed) 21 CFR 8621660 Class I Product Code: JJY C. Predicate Devices Triage@Cardiac Controls (K974461) Triage@BNP Controls (K000230) D. Device Description and Intended Use The Triage@Cardio ProfilER / Triage' Cardiac Co… | 1997 |
| * | K000230 | Triage B-Type Natriuretic Peptide (BNP) ControlsSummary page 1…21 CFR 8621660 Class I Product Code: JJY C. Predicate Devices Triage@Cardiac Controls (K974461) Triage@BNP Controls (K000230) D. Device Description and Intended Use The Triage@Cardio ProfilER / Triage' Cardiac Controls are to be used with the… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040459 | Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls | 2004 | 2 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K040459 (Biosite Incorporated, 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Triage@Cardio ProfilER / Triage@Cardiac Controls are to be used with the Triage@Cardio ProfilER / Triage@Cardiac Panel and Triage@Meter to assist the laboratory in monitoring test performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030089: Triage Cardiac Controls; Triage Cardio Profiler Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030089
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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