510(k) · Cleared
ClearedTriage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication 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 17, 2003 as substantially equivalent to K974827 (Biosite Incorporated, 1998) and 1 other predicate after a 7-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Jan 17, 2003
- Review
- 7 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974827 (1998). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974827 Triage (R) Cardiac Panel Calibration Verification Controls, Triag…Biosite Incorporated · 1998
- This deviceK030088 Triage Cardiac Calibration Verification Controls, Triage Cardio…Biosite 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 | K974827 | Triage (R) Cardiac Panel Calibration Verification Controls, Triag (R)… | Biosite Incorporated | 1998 | — |
| 0 (this device) | K030088 | Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler… | 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 |
|---|---|---|---|
| * | K974827 | Triage (R) Cardiac Panel Calibration Verification Controls, Triag (R) Myoglobin…Summary page 1…21 CFR 862:1660 Class I Product Code: JJY C. Predicate Devices Triage@Cardiac Calibration Verification Controls (K974827) Triage@BNP Calibration Verification Controls (KO00231) D. Device Description and Intended Use The Triage@ Cardio P… | 1998 |
| * | K000231 | Triage BNP Calibration Verification Controls | 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 Calibration Verification Controls are to be used with the Triage@Cardio ProfilER / Triage@Cardiac Panel and Triage@Meter to verify the calibration of the Triage@Cardio ProfilER / Triage@Cardiac Panel throughout the measurable range.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030088: Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030088
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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