510(k) · Cleared
ClearedElecsys Myoglobin Stat, and Elecsys Myoglobin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Oct 16, 2009 as substantially equivalent to K983176 (Boehringer Mannheim Corp., 1998) after a 345-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Oct 16, 2009
- Review
- 345 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902154 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK902154 NA Latex Myoglobin TestBehring Diagnostics, Inc. · 1990
- 2 generations backK972513 Tinaquant Myoglobin AssayBoehringer Mannheim Corp. · 1997
- 1 generation backK983176 Elecsys Myoglobin Stat AssayBoehringer Mannheim Corp. · 1998
- This deviceK083260 Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902154 | NA Latex Myoglobin Test | Behring Diagnostics, Inc. | 1990 | — |
| −2 | K972513 | Tinaquant Myoglobin Assay | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K983176 | Elecsys Myoglobin Stat Assay | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K083260 | Elecsys Myoglobin Stat, and Elecsys Myoglobin | Roche Diagnostics | 2009 | — |
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 DDR? 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 DDR device
- #1 K231832 Access Myoglobinscore 6.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K983176 | Elecsys Myoglobin Stat AssaySummary page 2…lyzers. Predicate The Elecsys Myoglobin and Elecsys Myoglobin STAT assays are Device substantially equivalent to the Elecsys Myoglobin STAT assay (K983176). Substantial The following table compares the new Elecsys Myoglobin and Elecsys Equivalence - Myoglobin STAT assay… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DDR devicesDDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DDR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DDR
Too few DDR 510(k)s in any year since 2007 to give a median.
Recalls per year · DDR
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DDR
5in 2025
MAUDE reports naming product code DDR, 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 | 0 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 31 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083260: Elecsys Myoglobin Stat, and Elecsys Myoglobin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083260
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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