(25 days)
Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.
The Access Ostase QC are bi-level ready-to-use defined protein-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 1 X 4 mL bottles for each level of control.
The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those acceptance criteria. It primarily focuses on the submission details, regulatory classification, and intended use of the Access Ostase QC device.
However, based on the general understanding of Quality Control Materials for in vitro diagnostics, I can infer the likely nature of such a study and the potential acceptance criteria, though the specific values are not present in the document.
Here's a breakdown of what can be extracted and what needs to be inferred for a Quality Control Material like "Access Ostase QC":
Inferred Acceptance Criteria and Reported Device Performance (as typically expected for QC materials):
| Acceptance Criteria Category | Typical Acceptance Criteria for QC Material (Inferred) | Reported Device Performance (Not found in provided text) |
|---|---|---|
| Accuracy (Trueness) | Mean measured value of the QC material falls within a pre-defined range of the target/assigned value (e.g., +/- X% of the target value for each level). | Specific mean measured values and their deviation from target values for Level 1 and Level 2 would be reported. |
| Precision (Repeatability/Within-Run) | Coefficient of Variation (CV%) for replicate measurements of the QC material is below a specified threshold (e.g., |
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.