(22 days)
The IMMULITE® HCG Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE HCG assay on the IMMULITE 2000 systems.
The IMMULITE® Insulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Insulin assay on the IMMULITE 2000 systems.
The IMMULITE® Pyrilinks-D Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Pyrilinks-D assay on the IMMULITE 2000 systems.
The IMMULITE® Homocysteine Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Homocysteine assay on the IMMULITE 2000 systems.
The IMMULITE® Growth Hormone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Growth Hormone assay on the IMMULITE 2000 systems.
IMMULITE® 2000 HCG Calibration Verification Material: The Calibration Verification Material (CVM) contains One set of four vials each 3mL. CVM1 contains HCG-free human serum with preservatives. CVM2. CVM3 and CVM4 contain HCG added to HCG-free human serum respectively, with preservatives.
IMMULITE® 2000 Insulin Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVMI contains an equine serum matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of insulin in an equine serum matrix with preservatives.
IMMULITE® 2000 Pyrilinks-D Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM1 contains a phosphoric acid and sodium chloride matrix. CVM2, CVM3 and CVM4 contain various levels of H-Deoxypyridinoline in a phosphoric acid and sodium chloride matrix.
IMMULITE® 2000 Homocysteine Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 2mL each. CVM 1 contains a bovine protein/buffer matrix with preservatives. CVM2, CVM3 and CVM4, contain various levels of s-adenosyl-L-homocysteine in a bovine protein/buffer matrix with preservatives.
IMMULITE® 2000 Growth Hormone Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM 1 contains an equine serum matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of human growth hormone in equine serum matrix with preservatives.
The provided text describes the acceptance criteria and performance data for several Calibration Verification Materials (CVMs) for the IMMULITE 2000 system, specifically for HCG, Insulin, Pyrilinks-D, Homocysteine, and Growth Hormone assays. The information is presented in sections relating to each CVM. I will extract the requested information for each CVM separately.
IMMULITE® 2000 HCG Calibration Verification Material
1. A table of acceptance criteria and the reported device performance:
| CVM Level | Assigned Dose (mIU/mL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (mIU/mL) | Reported Performance (Guideline Range based on Target Mean & ±2SD) (mIU/mL) |
|---|---|---|---|---|
| LCGCVM1 | 0.00 | N/A |
§ 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.