(323 days)
The Rapidpoint™Coag Enoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, ≥ 1.0 IU/ml, of the low molecular weight heparin (LMWH), Lovenox®/Clexane® (enoxaparin sodium)¹, in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX test is intended for use at either the point of care or in the central laboratory. The device does not discriminate between values of enoxaparin below 1.0 IU/ml and the absence of drug.
The test provides information on the patient's citrated arterial whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method and should be interpreted in conjunction with other clinical data available to the clinician
The RapidPoint Enoxaparin (ENOX) test is a one-step dry coagulation method performed on the RapidPoint Coag analyzer. All of the components necessary to perform the assay, with the exception of patient sample, are included in the reaction chamber of the test card.
In the ENOX test, factor X is rapidly converted to factor Xa by a specific factor X activator initiating the clotting process. Enoxaparin, from the patient's blood, complexes with antithrombin (AT), to inhibit factor Xa and lengthen the clotting time. Reported clotting times in excess of the assay cut-off indicate an enoxaparin concentration greater than or equal to 1.0 International Units per milliliter. The results generated by the ENOX test are indicative of the anticoagulant effect produced by enoxaparin in citrated arterial whole blood.
The test card formulation contains purified Factor Xa activator, calcium, phospholipid and stabilizers. Paramagnetic iron oxide particles (PIOP) are included to provide an optical detection mechanism in the presence of patient sample.
Here's a summary of the acceptance criteria and study details for the Thrombolytic Assessment System (TAS) or Rapidpoint™ Coag Enoxaparin (ENOX) Test Card.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the clinical study's results in relation to the intended use. The device is intended to detect enoxaparin levels ≥1.0 IU/mL. The study uses a clotting time cutoff of ≥ 260 seconds to indicate this.
| Acceptance Criteria (Implied) | Reported Device Performance (Clinical Study) |
|---|---|
| Detect enoxaparin ≥1.0 IU/mL (indicated by clotting time ≥ 260 seconds) | Sensitivity: 96.3% (95% CI: 89.4-99.2) |
| Discriminate enoxaparin |
§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).