(75 days)
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.
Acceptance Criteria and Study for HemosIL Calibration Plasma
This device, HemosIL Calibration Plasma, is a calibrator for coagulation assays. The performance data presented focuses on its precision in various coagulation analytes. Due to the nature of a calibrator, the acceptance criteria are implicitly tied to the precision requirements for each analyte as demonstrated by the predicate devices or established laboratory practice for calibration quality.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. However, typical acceptance criteria for calibrators revolve around established precision limits (e.g., %CV) that ensure the calibrator is stable and reliable for its intended use. The reported "Within Run %CV" values would be compared against these unstated, but generally understood, acceptable precision ranges for each analyte.
| Analyte | Reagent | Reported Mean | Reported Within Run %CV | Implicit Acceptance Criteria (Example) |
|---|---|---|---|---|
| APTT (Seconds) | HemosIL APTT-SP | 30.5 | 1.15 | e.g., |
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.