510(k) · Cleared
Recalled · 2009Abbott Axsym Myoglobin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Nov 16, 1998 after a 17-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 16, 1998
- Review
- 17 days
- Class
- Class II
- Product code
- DDR
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK983848 Abbott Axsym MyoglobinAbbott Laboratories · 1998
- Descendant · cites it directly · 3 of its ownK042924 Architect Stat Myo ImmunoassayFisher Diagnostics · 2005 · Recalled
- Descendant · 2 generations on · 1 of its ownK120326 AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3…Radiometer Medical Aps · 2012
- Descendant · 2 generations on · 1 of its ownK112161 AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…Radiometer Medical Aps · 2012
- Descendant · 3 generations on · 0 of its ownK163462 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017
Most influential descendants
Showing 4 of 4 · See all- K042924Architect Stat Myo ImmunoassayFisher Diagnostics · 2005 · cites it directly3descendants
- K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…Radiometer Medical Aps · 2012 · 2 generations on1descendant
- K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…Radiometer Medical Aps · 2012 · 2 generations on1descendant
- K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983848 | Abbott Axsym Myoglobin | Abbott Laboratories | 1998 | — |
| +1 | K042924 | Architect Stat Myo Immunoassay | Fisher Diagnostics | 2005 | 2 |
| +2 | K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex… | Radiometer Medical Aps | 2012 | — |
| +2 | K112161 | AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC… | Radiometer Medical Aps | 2012 | — |
| +3 | K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | Radiometer Medical Aps | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | — | Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042924 | Architect Stat Myo Immunoassay | 2005 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2009 | Not classified | Z-1050-2009 | Employee error | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. |
| Apr 23, 2007 | Not classified | Z-1030-2007 | Other | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042924 (Fisher Diagnostics, 2005) has gone furthest, with 3 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?
AxSYM® Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System. Measurements obtained by this device aid in the rapid diagnosis of heart or 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/K983848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983848: Abbott Axsym Myoglobin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983848
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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