510(k) · Cleared
ClearedElecsys Myoglobin Stat Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Sep 24, 1998 as substantially equivalent to K972513 (Boehringer Mannheim Corp., 1997) after a 14-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Sep 24, 1998
- Review
- 14 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902154 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902154 NA Latex Myoglobin TestBehring Diagnostics, Inc. · 1990
- 1 generation backK972513 Tinaquant Myoglobin AssayBoehringer Mannheim Corp. · 1997
- This deviceK983176 Elecsys Myoglobin Stat AssayBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 0 of its ownK083260 Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics · 2009
Most influential descendants
Showing 1 of 1 · See all- K083260Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902154 | NA Latex Myoglobin Test | Behring Diagnostics, Inc. | 1990 | — |
| −1 | K972513 | Tinaquant Myoglobin Assay | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K983176 | Elecsys Myoglobin Stat Assay | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K083260 | Elecsys Myoglobin Stat, and Elecsys Myoglobin | Roche Diagnostics | 2009 | — |
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 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 |
|---|---|---|---|
| * | K972513 | Tinaquant Myoglobin AssaySummary page 3…to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Tina-quant® Myoglobin Assay (K972513). The following table compares the Elecsys® Myoglobin with the predicate device, Tina-quant® Myoglobin Assay. Specific data on t… | 1997 |
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 |
|---|---|---|---|
| K083260 | Elecsys Myoglobin Stat, and Elecsys Myoglobin | 2009 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083260 (Roche Diagnostics, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K972513.
How does its category compare?
All DDR devicesDDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For the in vitro-quantitative determination of myoglobin in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim immunoassay analyzers.
A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983176 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983176: Elecsys Myoglobin Stat Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983176
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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