510(k) · Cleared
ClearedChiron Diagnostics Acs:180 Myoglobin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Diagnostics Corp. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Dec 8, 1997 after a 20-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Dec 8, 1997
- Review
- 20 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK974325 Chiron Diagnostics Acs:180 MyoglobinChiron Diagnostics Corp. · 1997
- Descendant · cites it directly · 0 of its ownK122599 Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK991277 Modification to Immulite Myoglobin, Model LKMY1, LKMY5Diagnostic Products Corp. · 1999
- Descendant · cites it directly · 0 of its ownK983970 Immulite Myoglobin, Model LKMY1 and LKMY5Diagnostic Products Corp. · 1998
Most influential descendants
Showing 3 of 3 · See all- K122599Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012 · cites it directly0descendants
- K991277Modification to Immulite Myoglobin, Model LKMY1, LKMY5Diagnostic Products Corp. · 1999 · cites it directly0descendants
- K983970Immulite Myoglobin, Model LKMY1 and LKMY5Diagnostic Products Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974325 | Chiron Diagnostics Acs:180 Myoglobin | Chiron Diagnostics Corp. | 1997 | — |
| +1 | K122599 | Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator | Siemens Healthcare Diagnostics, Inc. | 2012 | 1 |
| +1 | K991277 | Modification to Immulite Myoglobin, Model LKMY1, LKMY5 | Diagnostic Products Corp. | 1999 | — |
| +1 | K983970 | Immulite Myoglobin, Model LKMY1 and LKMY5 | Diagnostic Products Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | — | Stratus Myoglobin Fluorometric Enzyme Immunoassay Named without a submission number |
What descends from it? (3)
3 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, K122599 (Siemens Healthcare Diagnostics, Inc., 2012) has gone furthest, with 0 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 | — |
What is it indicated for?
The Chiron Diagnostics ACS:180 Myoglobin Assay is used for the quantitative determination of Myoglobin in serum or plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS Automated Chemiluminescence Systems.
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/K974325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974325: Chiron Diagnostics Acs:180 Myoglobin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974325
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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