(162 days)
ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.
ACTICHROME® Heparin (anti-fIIa) Product No. 820
The provided text describes a 510(k) summary for the ACTICHROME® Heparin (anti-fIIa) assay. It focuses on demonstrating substantial equivalence to a predicate device, primarily through method comparison and precision studies.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for demonstrating substantial equivalence. Instead, it relies on a strong "positive correlation" with the predicate device and acceptable precision (CV%).
| Performance Metric | Acceptance Criteria (Implied/General) | Reported Device Performance (ACTICHROME Heparin (anti-fIIa)) |
|---|---|---|
| Method Comparison | Strong positive correlation (e.g., R-value > 0.9) and regression equation demonstrating agreement with predicate. | Lot 010 (N=88): R = 0.967, Y = 0.845X + 0.027 |
| Lot 010 (N=32): R = 0.917, Y = 0.764X + 0.032 | ||
| Sy.x (ng/ml) = 0.03 (N=88), 0.05 (N=32) | ||
| Intra-Assay Precision (CV%) | Low variability (e.g., typically |
§ 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).