(561 days)
MPO Flex® reagent cartridge: 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.
MPO Calibrator: 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.
MPO Control: 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.
The MPO method is a one-step enzyme immunoassay based on the "sandwich" principle. The sample is incubated with chromium dioxide particles coated with monoclonal antibodies specific for MPO, and conjugate reagent (13-galactosidase labeled monoclonal antibodies specific for MPO). A particle/MPO/conjugate sandwich forms during the incubation period. Unbound conjugate is removed by magnetic separation and washing. The sandwich bound fl-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-D-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The concentration of MPO present in the patient sample is directly proportional to the rate of color change due to formation of CPR measured at 577 nm.
The provided text describes the Siemens Healthcare Diagnostics Dimension MPO Flex® reagent cartridge and its associated calibrator and control. The information focuses on demonstrating substantial equivalence to a predicate device, the PrognostiX CardioMPO™ Enzyme Immunoassay. The study does not involve an AI device, therefore, some of the requested information such as MRMC study, and number of experts to establish ground truth is not applicable.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria (from predicate device) and Reported Device Performance:
| Feature | Predicate Device (PrognostiX MPO) Acceptance Criteria (as reported) | Dimension® MPO Flex® (Reported Performance) |
|---|---|---|
| Intended Use | Quantitative determination of myeloperoxidase in human plasma to evaluate patients at risk for major adverse cardiac events (MACE). | Quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system, for evaluating patients at risk for MACE. |
| Assay Type | Sandwich enzyme immunoassay | Sandwich enzyme immunoassay |
| Reportable Range | 13 to 5000 pmol/L | 20 to 5000 pmol/L |
| Hook Effect | No high dose effect up to 800,000 pmol/L | No high dose effect up to 800,000 pmol/L |
| Odds Ratio (Clinical) | Increases from 1.0 to a max. of 3.3 across 4 quartiles | Increases from 1.0 to a max. of 4.29 across 4 quartiles (30 days MACE) |
| Expected Values | ≤ 539 pmol/L (presumably a reference range) | 20 - 633 pmol/L (presumably a reference range) |
| Analytical Specificity |
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).