510(k) · Cleared
Recalled · Class II · 2020Triage Total Controls 5, Triage Total Calibration Verification 5
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 Dec 7, 2007 as substantially equivalent to K040459 (Biosite Incorporated, 2004) after a 58-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Dec 7, 2007
- Review
- 58 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 3 generations to K974827 (1998). 7 ancestors in all, the oldest K974461 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK974827 Triage (R) Cardiac Panel Calibration Verification Controls, Triag…Biosite Incorporated · 1998
- 2 generations backK030088 Triage Cardiac Calibration Verification Controls, Triage Cardio…Biosite Incorporated · 2003
- 1 generation backK040459 Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification…Biosite Incorporated · 2004
- This deviceK072892 Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 2007
- Descendant · cites it directly · 0 of its ownK093032 Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009
Most influential descendants
Showing 1 of 1 · See all- K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974827 | Triage (R) Cardiac Panel Calibration Verification Controls, Triag (R)… | Biosite Incorporated | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5 | Biosite Incorporated | 2007 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K040459 | Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification ControlsSummary page 1…Quality Control Material (Assayed and Unassayed) Product Code: JJY 3. Predicate Devices K040459 - Triage® Profiler S.OB. (Shortness of Breath) Controls and the Triage® Profiler S.O.B. Calibration Verification Controls… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093032 | Triage Total 3 Controls and Calibration Verification Set | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2020 | Class II | Z-3054-2020 | Process control | Product was shipped with refrigeration (ice) instead of frozen (dry ice). |
| Oct 12, 2016 | Class II | Z-0588-2017 | Employee error | Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card. |
| Feb 6, 2009 | Not classified | Z-1790-2010 | Other | Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field. |
| Feb 6, 2009 | Not classified | Z-1789-2010 | Other | Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field. |
| Feb 6, 2009 | Not classified | Z-1788-2010 | Other | Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K093032 (Biosite Incorporated, 2009) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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 Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B. TM Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance.
The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B. TM Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072892: Triage Total Controls 5, Triage Total Calibration Verification 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072892
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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