510(k) · Cleared
Recalled · Class II · 2024Architect Stat Myo Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher Diagnostics · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Jan 24, 2005 as substantially equivalent to K983848 (Abbott Laboratories, 1998) after a 94-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 24, 2005
- Review
- 94 days
- Class
- Class II
- Product code
- DDR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983848 (1998). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983848 Abbott Axsym MyoglobinAbbott Laboratories · 1998 · Recalled
- This deviceK042924 Architect Stat Myo ImmunoassayFisher Diagnostics · 2005
- Descendant · cites it directly · 1 of its ownK120326 AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3…Radiometer Medical Aps · 2012
- Descendant · cites it directly · 1 of its ownK112161 AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…Radiometer Medical Aps · 2012
- Descendant · 2 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 3 of 3 · See all- K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…Radiometer Medical Aps · 2012 · cites it directly1descendant
- K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…Radiometer Medical Aps · 2012 · cites it directly1descendant
- K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983848 | Abbott Axsym Myoglobin | Abbott Laboratories | 1998 | 2 |
| 0 (this device) | K042924 | Architect Stat Myo Immunoassay | Fisher Diagnostics | 2005 | — |
| +1 | K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex… | Radiometer Medical Aps | 2012 | — |
| +1 | K112161 | AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC… | Radiometer Medical Aps | 2012 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K983848 | Abbott Axsym MyoglobinSummary page 1…ing Regulation: 21 CFR 866.5680 FDA Panel: Clinical Chemistry Product Code: MVE Identification of Predicate Device: Abbott AxSYMO MYG Assay (K983848) Intended Use of the Device: ARCHITECT® STAT MYO is a Chemiluminescent Microparticle Immunoassay (CMIA) for th… | 1998 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2024 | Class II | Z-1476-2024 | Nonconforming Material/Component | The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial… |
| Mar 8, 2022 | Class II | Z-0891-2022 | Under Investigation by firm | This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K120326 (Radiometer Medical Aps, 2012) has gone furthest, with 1 descendant 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?
ARCHITECT STAT MYOGLOBIN is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Myoglobin in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT MYOGLIBIN Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of myoglobin in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042924: Architect Stat Myo Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042924
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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