510(k) · Cleared
ClearedTinaquant Myoglobin 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 Jul 28, 1997 as substantially equivalent to K902154 (Behring Diagnostics, Inc., 1990) after a 21-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.
- Decided
- Jul 28, 1997
- Review
- 21 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902154 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902154 NA Latex Myoglobin TestBehring Diagnostics, Inc. · 1990
- This deviceK972513 Tinaquant Myoglobin AssayBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 1 of its ownK061683 Tina-Quant Myoglobin Gen.2 Test SystemRoche Diagnostics Corp. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK983176 Elecsys Myoglobin Stat AssayBoehringer Mannheim Corp. · 1998
- Descendant · 2 generations on · 0 of its ownK123785 Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013
- Descendant · 2 generations on · 0 of its ownK083260 Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics · 2009
Most influential descendants
Showing 4 of 4 · See all- K061683Tina-Quant Myoglobin Gen.2 Test SystemRoche Diagnostics Corp. · 2006 · cites it directly1descendant
- K983176Elecsys Myoglobin Stat AssayBoehringer Mannheim Corp. · 1998 · cites it directly1descendant
- K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013 · 2 generations on0descendants
- K083260Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902154 | NA Latex Myoglobin Test | Behring Diagnostics, Inc. | 1990 | — |
| 0 (this device) | K972513 | Tinaquant Myoglobin Assay | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K061683 | Tina-Quant Myoglobin Gen.2 Test System | Roche Diagnostics Corp. | 2006 | 1 |
| +1 | K983176 | Elecsys Myoglobin Stat Assay | Boehringer Mannheim Corp. | 1998 | — |
| +2 | K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control Set | Diazyme Laboratories | 2013 | — |
| +2 | K083260 | Elecsys Myoglobin Stat, and Elecsys Myoglobin | Roche Diagnostics | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K902154 | NA Latex Myoglobin TestSummary page 3…ther products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring N Latex Myoglobin Assay (K902154). The following table compares the Tina-quant® Myoglobin with the predicate device, Behring Nephlometer Myoglobin Assay. Specifi… | 1990 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
The Tina-quant® Myoglobin Assay is an immunoturbidometric assay for the quantitative determination of Myoglobin in serum and plasma using automated clinical chemistry analyzers. 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/K972513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972513: Tinaquant Myoglobin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972513
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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