(107 days)
ACL AcuStar: Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
HemosIL AcuStar D-Dimer: Fully automated chemiluminescent immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL AcuStar as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)].
HemosIL AcuStar D-Dimer Controls: For the quality control of D-Dimer assay performed on the ACL AcuStar.
ACL AcuStar: The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in blood samples by: Subjecting the blood sample to reagents that cause a reaction with an antigen or antibody in the sample. Placing the cuvettes in a controlled environment to allow the reactants to bind into a complex. Separating out the complex from unused reactants. Treating this complex with a chemical that produces light in proportion to the analyte concentration. Measuring the light output to determine the amount of antibodies or antigens that were in the sample.
HemosIL AcuStar D-Dimer: The HemosIL AcuStar D-Dimer assay is a two-step immunoassay to quantify D-Dimer in human citrated plasma using magnetic particles as solid phase and a chemiluminescent detection system. In the first step, sample, anti-D-Dimer antibody coated magnetic particles, and assay buffer are combined, and the fibrin soluble derivatives containing the D-Dimer domain present in the sample bind to the anti-D-Dimer antibody coated magnetic particles. After magnetic separation and washing, an anti-XDP antibody labeled with isoluminol is added and incubated in a second step. After a new magnetic separation and washing, two triggers are added and the resulting chemiluminescent reaction is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the D-Dimer concentration in the sample. The ACL AcuStar D-Dimer assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined lot dependent, and is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator plastic tube barcodes.
HemosIL AcuStar D-Dimer Controls: The Low, High, and Very High D-Dimer Controls are prepared by means of a dedicated process and contain different concentrations of partially purified D-Dimer obtained by digestion of Factor XIIIa cross-linked human fibrin with human plasmin.
Here's a breakdown of the acceptance criteria and the study details for the ACL™ AcuStar™ HemosIL™ AcuStar™ D-Dimer, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|---|
| Precision | Coefficient of Variation (CV%) for D-Dimer Controls and Calibrator 1 | The document does not explicitly state numerical acceptance criteria for precision (e.g., CV% |
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.