510(k) · Cleared
ClearedDimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,Control, Model RF425, RC425,RC426
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · NTV Myeloperoxidase, Immunoassay, System, Test
Cleared on Dec 10, 2008 as substantially equivalent to K050029 (Prognostix, Inc., 2005) after a 561-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 10, 2008
- Review
- 561 days
- Class
- Class II
- Product code
- NTV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000121 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK000121 Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array…Beckman Coulter, Inc. · 2000
- 3 generations backK013128 N Latex LP (a)Dade Behring, Inc. · 2002
- 2 generations backK030477 Diadexus Plac TestDiadexus, Inc. · 2003 · Recalled
- 1 generation backK050029 Cardiompo TestPrognostix, Inc. · 2005
- This deviceK071474 Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge…Siemens Healthcare Diagnostics · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000121 | Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System… | Beckman Coulter, Inc. | 2000 | — |
| −3 | K013128 | N Latex LP (a) | Dade Behring, Inc. | 2002 | — |
| −2 | K030477 | Diadexus Plac Test | Diadexus, Inc. | 2003 | 2 |
| −1 | K050029 | Cardiompo Test | Prognostix, Inc. | 2005 | — |
| 0 (this device) | K071474 | Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge… | Siemens Healthcare Diagnostics | 2008 | — |
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 NTV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K050029 | Cardiompo TestSummary page 1…munoassay, System, Test (866.5600) FDA Guidance Documents: None applicable Predicate Device(s): PrognostiX CardioMPOrm Enzyme Immunoassay (K050029) Device Description(s): The MPO method is a one-step enzyme immunoassay based on the "sandwich" principle. The sample is… | 2005 |
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 8 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K050029.
How does its category compare?
All NTV devicesNTV Myeloperoxidase, Immunoassay, System, Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NTV
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NTV
Too few NTV 510(k)s in any year since 2007 to give a median.
Recalls per year · NTV
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NTV
No MAUDE report names NTV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for…
Read the full statement (136 words)
The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death.
The MPO Calibrator is an in vitro diagnostic product intended to be used to calibrate the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module.
The myeloperoxidase control is an in vitro diagnostic product intended for use as an assayed quality control product to monitor the performance of the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071474: Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,Control, Model RF425, RC425,RC426.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071474
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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