510(k) · Cleared
ClearedAccess Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Feb 20, 2009 as substantially equivalent to K021229 (Beckman Coulter, Inc., 2002) after a 364-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 20, 2009
- Review
- 364 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000196 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK000196 Access Myoglobin on the Access Immunoassay Analyzer, Models 33310…Beckman Coulter, Inc. · 2000
- 1 generation backK021229 Myoglobin and Myoglobin Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2002 · Recalled
- This deviceK080481 Access Immunoassay Systems Myoglobin and Access Immunoassay Systems…Beckman Coulter, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000196 | Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315… | Beckman Coulter, Inc. | 2000 | — |
| −1 | K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2002 | 1 |
| 0 (this device) | K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin… | Beckman Coulter, Inc. | 2009 | — |
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 |
|---|---|---|---|
| * | K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…Summary page 1…: Myoglobin Enzyme Immunoassay Product classification: Class 11 Product code: DDR; JIS Predicate device: Acce ss Myoglobin Assay -. k021229 Device description: The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyze… | 2002 |
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 9 years and passes through 1 company; a new generation was cleared every 6.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K021229.
How does its category compare?
All DDR devicesDDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080481 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080481: Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080481
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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