510(k) · Cleared
ClearedNA Latex Myoglobin Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Jun 1, 1990 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jun 1, 1990
- Review
- 17 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK902154 NA Latex Myoglobin TestBehring Diagnostics, Inc. · 1990
- Descendant · cites it directly · 4 of its ownK972513 Tinaquant Myoglobin AssayBoehringer Mannheim Corp. · 1997
- Descendant · 2 generations on · 1 of its ownK061683 Tina-Quant Myoglobin Gen.2 Test SystemRoche Diagnostics Corp. · 2006 · Recalled
- Descendant · 2 generations on · 1 of its ownK983176 Elecsys Myoglobin Stat AssayBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 1 of its ownK973358 Myoglobin Control SetBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 1 of its ownK963292 Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K972513Tinaquant Myoglobin AssayBoehringer Mannheim Corp. · 1997 · cites it directly4descendants
- K061683Tina-Quant Myoglobin Gen.2 Test SystemRoche Diagnostics Corp. · 2006 · 2 generations on1descendant
- K983176Elecsys Myoglobin Stat AssayBoehringer Mannheim Corp. · 1998 · 2 generations on1descendant
- K973358Myoglobin Control SetBoehringer Mannheim Corp. · 1997 · cites it directly1descendant
- K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902154 | NA Latex Myoglobin Test | Behring Diagnostics, Inc. | 1990 | — |
| +1 | K972513 | Tinaquant Myoglobin Assay | Boehringer Mannheim Corp. | 1997 | — |
| +2 | K061683 | Tina-Quant Myoglobin Gen.2 Test System | Roche Diagnostics Corp. | 2006 | 1 |
| +2 | K983176 | Elecsys Myoglobin Stat Assay | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K973358 | Myoglobin Control Set | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K963292 | Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1996 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
4 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?
- Of its descendants, K972513 (Boehringer Mannheim Corp., 1997) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K902154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902154: NA Latex Myoglobin Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902154
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026