510(k) · Cleared
Recalled · Class II · 2016Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Oct 3, 2012 as substantially equivalent to K974325 (Chiron Diagnostics Corp., 1997) and 2 other predicates after a 37-day review. Its family tree reaches back 4 generations to 1990. It has been recalled once.
- Decided
- Oct 3, 2012
- Review
- 37 days
- Class
- Class II
- Product code
- DDR
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902336 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 3 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 2 generations backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- 1 generation backK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- This deviceK122599 Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −3 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −2 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −1 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| 0 (this device) | K122599 | Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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? (3)
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 |
|---|---|---|---|
| * | K974325 | Chiron Diagnostics Acs:180 MyoglobinSummary page 2…F. Predicate Device: Reagent 1. Device Name: ADVIA Centaur Myoglobin Reagent 2. Common Name: ADVIA Centaur Myoglobin Reagent 3. 510(k) Number: K974325 and k041 133 4. Manufacturer: Siemens Healthcare Diagnostics Inc. Calibrator 1. Device Name: Dimension Clinical Chemistry… | 1997 |
| * | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerSummary page 2…=== F. Predicate Device: Reagent 1. Device Name: ADVIA Centaur Myoglobin Reagent 2. Common Name: ADVIA Centaur Myoglobin Reagent 3. 510(k) Number: K974325 and k041 133 4. Manufacturer: Siemens Healthcare Diagnostics Inc. Calibrator 1. Device Name: Dimension Clinical Chemistry System Myogl… | 2004 |
| * | K984193 | Dimensions RXL Myoglobin (Myo) CalibratorSummary page 2…vice Name: Dimension Clinical Chemistry System Myoglobin Calibrator 2. Common Name: Dimension Clinical Chemistry System Myoglobin Calibrator 3. 510(k) Number: k9841 93 4. Manufacturer: Siemens Healthcare Diagnostics Inc. G. Intended Use: The ADVIA® Chemistry Myocilobin assay is for in vitro… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2016 | Class II | Z-2899-2016 | Nonconforming Material/Component | Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K974325.
How does its category compare?
All DDR devicesDDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ADVIA® Chemistry Myoglobin assay is intended for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ADVIA Chemistry Myoglobin calibrator is intended for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122599: Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122599
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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