510(k) · Cleared
ClearedTriage Profiler S.O.B. Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Jun 25, 2004 as substantially equivalent to K973126 (Biosite Incorporated, 1997) and 2 other predicates after a 127-day review. Its family tree reaches back 3 generations to 1986. 1 of the 8 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 25, 2004
- Review
- 127 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K862156 (1986). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 2 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 1 generation backK022976 Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr &…Dade Behring, Inc. · 2003 · Recalled
- This deviceK040437 Triage Profiler S.O.B. PanelBiosite Incorporated · 2004
- Descendant · cites it directly · 0 of its ownK042723 Trigage Profiler S.O.B. Panel, Model 97300Biosite Incorporated · 2004
- Descendant · cites it directly · 0 of its ownK042890 Triage D-Dimer Test, Model 98100Biosite Incorporated · 2004 · Recalled (Class I)
Class I recalls in this family
- K042890 Triage D-Dimer Test, Model 98100cites it directly · 2004
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 |
|---|---|---|---|---|---|
| −3 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −2 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −1 | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D | Dade Behring, Inc. | 2003 | 1 |
| 0 (this device) | K040437 | Triage Profiler S.O.B. Panel | Biosite Incorporated | 2004 | — |
| +1 | K042723 | Trigage Profiler S.O.B. Panel, Model 97300 | Biosite Incorporated | 2004 | — |
| +1 | K042890 | Triage D-Dimer Test, Model 98100 | Biosite Incorporated | 2004 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 1 |
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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DAP device
- #1 K253985 INNOVANCE® D-Dimer 2.0 (SMN 10873803)score 13.0 · 5 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K973126 | Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage…Summary page 2…Fibrinogen/Fibrin Degradation Products Assay (864.7320) Product Code GHH C. Predicate Devices Triage® Cardiac Panel (K973126) Triage® BNP Test (K021317) Dade Behring Stratus CS DDMR TestPak (K022976) D. Device Description and Intended Use… | 1997 |
| * | K021317 | Triage B-Type Natriuretic Peptide (BNP) TestSummary page 2…adation Products Assay (864.7320) Product Code GHH C. Predicate Devices Triage® Cardiac Panel (K973126) Triage® BNP Test (K021317) Dade Behring Stratus CS DDMR TestPak (K022976) D. Device Description and Intended Use The Triage® Profiler S.O.B.… | 2002 |
| * | K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-DSummary page 2…Product Code GHH C. Predicate Devices Triage® Cardiac Panel (K973126) Triage® BNP Test (K021317) Dade Behring Stratus CS DDMR TestPak (K022976) D. Device Description and Intended Use The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence i… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K042890Triage D-Dimer Test, Model 98100Biosite Incorporated · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K042723 (Biosite Incorporated, 2004) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K973126.
How does its category compare?
All DAP devicesDAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DAP
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DAP
127in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DAP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DAP
2in 2025
MAUDE reports naming product code DAP, 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 | 2 | — | 0 | 4 |
| 2008 | 3 | 127 | 0 | 10 |
| 2009 | 1 | — | 0 | 13 |
| 2010 | 2 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 1 | — | 1 | 38 |
| 2016 | 2 | — | 0 | 20 |
| 2017 | 1 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 7 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment…
Read the full statement (109 words)
The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040437 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040437: Triage Profiler S.O.B. Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040437
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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