510(k) · Cleared
ClearedTriage Profiler S.O.B. Controls and S.O.B. Calibration Verification 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 Jul 6, 2004 as substantially equivalent to K030088 (Biosite Incorporated, 2003) and 1 other predicate after a 134-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Jul 6, 2004
- Review
- 134 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974827 (1998). 6 ancestors in all, the oldest K974461 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK974827 Triage (R) Cardiac Panel Calibration Verification Controls, Triag…Biosite Incorporated · 1998
- 1 generation backK030088 Triage Cardiac Calibration Verification Controls, Triage Cardio…Biosite Incorporated · 2003
- This deviceK040459 Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification…Biosite Incorporated · 2004
- Descendant · cites it directly · 1 of its ownK072892 Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK093032 Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009
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 |
|---|---|---|---|---|---|
| −2 | K974827 | Triage (R) Cardiac Panel Calibration Verification Controls, Triag (R)… | Biosite Incorporated | 1998 | — |
| −1 | K030088 | Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler… | Biosite Incorporated | 2003 | — |
| 0 (this device) | K040459 | Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls | Biosite Incorporated | 2004 | — |
| +1 | K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5 | Biosite Incorporated | 2007 | 5 |
| +2 | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K030088 | Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration…Summary page 1…21 CFR 862:1660 Class I Product Code: JJY C. Predicate Devices Triage Cardio ProfilER Calibration Verification Controls (K030088) Triage Cardio ProfilER Controls (K030089) D. Device Description and Intended Use The Triage® Profil… | 2003 |
| * | K030089 | Triage Cardiac Controls; Triage Cardio Profiler ControlsSummary page 1…Product Code: JJY C. Predicate Devices Triage Cardio ProfilER Calibration Verification Controls (K030088) Triage Cardio ProfilER Controls (K030089) D. Device Description and Intended Use The Triage® Profiler S.O.B. (Shortness of Breath) Calibration Veri… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5 | 2007 | 1 |
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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K072892 (Biosite Incorporated, 2007) has gone furthest, with 1 descendant 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® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range.
The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040459 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040459: Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040459
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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