510(k) · Cleared
ClearedDiazyme Myoglobin; Assay, Calibrator Set, Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Jun 7, 2013 as substantially equivalent to K061683 (Roche Diagnostics Corp., 2006) and 1 other predicate after a 179-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jun 7, 2013
- Review
- 179 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K902154 (1990). 4 ancestors in all. 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 backK061683 Tina-Quant Myoglobin Gen.2 Test SystemRoche Diagnostics Corp. · 2006 · Recalled
- This deviceK123785 Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013
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 | K061683 | Tina-Quant Myoglobin Gen.2 Test System | Roche Diagnostics Corp. | 2006 | 1 |
| 0 (this device) | K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control Set | Diazyme Laboratories | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K061683 | Tina-Quant Myoglobin Gen.2 Test SystemSummary page 2…10k 21CFR 866.5680 Class 11 Predicate Device: Roche Tina-Quafit Myoglobin Gen. 2 Test System and C.f.a.s. (Calibrators for automated systems) Myoglobin (K061683) Myoglobin Control Set (K973358) Manufacturing Address _ Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 USA Establishme… | 2006 |
| * | K973358 | Myoglobin Control SetSummary page 2…== Page 2 === Predicate Device: Roche Tina-Quafit Myoglobin Gen. 2 Test System and C.f.a.s. (Calibrators for automated systems) Myoglobin (K061683) Myoglobin Control Set (K973358) Manufacturing Address _ Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 USA Establishment Registration 2032900 DESCRIP… | 1997 |
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 23 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All DDR devicesDDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.
The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
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/K123785 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123785: Diazyme Myoglobin; Assay, Calibrator Set, Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123785
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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