(154 days)
ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.
ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ACTICHROME® Heparin (anti-fXa) device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve an R-value of at least X"). Instead, it presents performance data and implies that equivalence to the predicate device is the overarching acceptance criterion. Thus, the "acceptance criteria" are inferred from the demonstrated performance in comparison to the predicate.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (ACTICHROME Heparin (anti-fXa)) |
|---|---|
| Method Comparison vs. Predicate Device | |
| Positive correlation with predicate device (implied R > 0.8) | Unfractionated Heparin (Lot 007): R = 0.913, Y = 0.843X + 0.003, Sy.x = 0.07 |
| Unfractionated Heparin (Lot 010): R = 0.859, Y = 0.765X - 0.009, Sy.x = 0.08 | |
| LMW Heparin (Lot 010): R = 0.895, Y = 1.363X - 0.139, Sy.x = 0.14 | |
| Precision (Intra-Assay CV%) | |
| Maintain low intra-assay variability (implied |
§ 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).