# K050029: Cardiompo Test

- Pathway: 510(k) (Traditional)
- Applicant: Prognostix, Inc.
- Decided: May 10, 2005 after 124 days
- Product code: NTV (Myeloperoxidase, Immunoassay, System, Test)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000121 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030477: Diadexus Plac Test, Diadexus, Inc. (2003) Summary page 1.

## Most influential descendants
- K071474: Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,Control, Model RF425, RC425,RC426 (2008), 0 descendants of its own
- K062840: Triage Protein C Controls and Calibration Verification Controls (2007), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K050029
Methodology: https://510kreport.com/methodology