510(k) · Cleared
ClearedCardiompo Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prognostix, Inc. · NTV Myeloperoxidase, Immunoassay, System, Test
Cleared on May 10, 2005 as substantially equivalent to K030477 (Diadexus, Inc., 2003) after a 124-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- May 10, 2005
- Review
- 124 days
- Class
- Class II
- Product code
- NTV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000121 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000121 Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array…Beckman Coulter, Inc. · 2000
- 2 generations backK013128 N Latex LP (a)Dade Behring, Inc. · 2002
- 1 generation backK030477 Diadexus Plac TestDiadexus, Inc. · 2003 · Recalled
- This deviceK050029 Cardiompo TestPrognostix, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK071474 Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge…Siemens Healthcare Diagnostics · 2008
- Descendant · cites it directly · 0 of its ownK062840 Triage Protein C Controls and Calibration Verification ControlsBiosite Incorporated · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000121 | Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System… | Beckman Coulter, Inc. | 2000 | — |
| −2 | K013128 | N Latex LP (a) | Dade Behring, Inc. | 2002 | — |
| −1 | K030477 | Diadexus Plac Test | Diadexus, Inc. | 2003 | 2 |
| 0 (this device) | K050029 | Cardiompo Test | Prognostix, Inc. | 2005 | — |
| +1 | K071474 | Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge… | Siemens Healthcare Diagnostics | 2008 | — |
| +1 | K062840 | Triage Protein C Controls and Calibration Verification Controls | Biosite Incorporated | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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 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 |
|---|---|---|---|
| * | K030477 | Diadexus Plac TestSummary page 1…CardioM PGTm Test Common Name: Myeloperoxidase Test Identificationof Legally Marketed Device diaDexus PLAC Tm Test 51 0(k) number K030477 diaDexus, Inc. 343 Oyster Point Blvd. South San Francisco, CA 94080 Intended Use The CardioMPO Test is an enzyme immunoassay inte… | 2003 |
What descends from it? (2)
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)
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 5 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K071474 (Siemens Healthcare Diagnostics, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030477.
How does its category compare?
All NTV devicesNTV Myeloperoxidase, Immunoassay, System, Test: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CardioMPO™ Test is comprised of the CardioMPO Reagent Kit, the CardioMPO Calibrator Kit, and the CardioMPO Control Kit. The CardioMPO Reagent Kit is an enzyme immunoassay intended for the quantitative determination of myeloperoxidase in human plasma, to 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…
Read the full statement (131 words)
The CardioMPO™ Test is comprised of the CardioMPO Reagent Kit, the CardioMPO Calibrator Kit, and the CardioMPO Control Kit.
The CardioMPO Reagent Kit is an enzyme immunoassay intended for the quantitative determination of myeloperoxidase in human plasma, to 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 PrognostiX CardioMPO Calibrator Kit is intended for use with the CardioMPO Reagent Kit to establish a calibration curve that is used to determine MPO concentration.
The PrognostiX CardioMPO Control Kit is intended for use with the CardioMPO Reagent Kit as an assayed quality control sample to monitor and evaluate the precision and accuracy of the CardioMPO Test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050029: Cardiompo Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050029
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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