(35 days)
The IMMULITE® Albumin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Albumin assay on the IMMULITE 2000 systems
The IMMULITE® Myoglobin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Myoglobin assay on the IMMULITE 2000 systems
The Albumin Calibration Verification Material (CVM) contains one set of four vials each 2.0 mL after reconstitution. CVM1 contains bovine protein with preservatives. CVM2, CVM3 and CVM4 contain various levels of human albumin in a bovine protein matrix with preservatives. The CVMs are supplied in lyophilized form.
IMMULITE® 2000 Myoglobin Calibration Verification Material (CVM) contains one set of four vials each 2.0mL after reconstitution. CVM1 contains bovine serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of human cardiac myoglobin in bovine serum with preservatives. The CVMs are supplied in lyophilized form.
The provided documents describe the performance testing for two medical devices: the IMMULITE® 2000 Albumin Calibration Verification Material (CVM) and the IMMULITE® 2000 Myoglobin Calibration Verification Material (CVM).
IMMULITE® 2000 Albumin Calibration Verification Material (CVM)
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is reported as meeting the acceptance criteria, as stated in the stability summaries. The studies aimed to demonstrate that the CVM maintains optimal product performance within the established shelves life before and after reconstitution.
Table: Acceptance Criteria and Reported Device Performance for IMMULITE® 2000 Albumin CVM
| Test | CVM Level | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Shelf Life Stability | LHACVM1 |
§ 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.