IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
Device Facts
| Record ID | K141444 |
|---|---|
| Device Name | IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product Code | JJX · Clinical Chemistry |
| Decision Date | Jul 9, 2014 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K141444 · Jul 9, 2014 | IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL | Siemens Healthcare Diagnostics, Inc. | Patient serum samples | Patient serum samples were used to validate the value assignment of the CVMs and to perform quality control by calculating the recovery of these samples. | Value assignment; Quality control; Patient serum samples |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Validation of calibrator/CVM value assignments using patient serum samples | Patient serum samples; Sample Size: 25 (Cortisol), 14 (Folic Acid), 21 (Vitamin B12) | Not applicable for this study | Recovery of patient samples using assigned CVM values |
Indications for Use
The IMMULITE® Cortisol Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Cortisol assay on the IMMULITE 2000 systems. The IMMULITE® Folic Acid Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Folic Acid assay on the IMMULITE 2000 systems. The IMMULITE® Vitamin B12 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of the IMMULITE Vitamin B12 assay on the IMMULITE 2000 systems.
Device Story
The IMMULITE 2000 Calibration Verification Materials (CVM) are multi-level, assayed quality control materials used to verify the calibration of specific assays on the IMMULITE 2000 system. The CVMs are provided as liquid (Cortisol) or lyophilized (Folic Acid, Vitamin B12) human serum or albumin-based matrices containing the respective analytes. The device is used in clinical laboratory settings by trained personnel. The healthcare provider runs the CVMs on the IMMULITE 2000 system; the instrument processes the samples and generates dose values based on the reference calibrator curve. The provider compares these recovered values against established target ranges to verify that the assay calibration remains accurate. This verification process ensures the reliability of patient sample testing, allowing for accurate clinical decision-making regarding patient diagnosis and monitoring.
Clinical Evidence
Bench testing only. Stability studies validated real-time shelf life and open-vial stability. Value assignment was validated using commercially available controls and patient serum samples. Acceptance criteria were based on guideline ranges (±2SD) and specific dose recovery limits for each analyte level.
Technological Characteristics
Multi-level (4 levels) calibration verification materials. Matrices: human serum (Cortisol) or human albumin (Folic Acid, Vitamin B12) with preservatives. Form: liquid or lyophilized. Storage: -20°C. Connectivity: used on IMMULITE 2000 systems. Stability: validated per CEN 13640.
Indications for Use
Indicated for in vitro diagnostic use to verify calibration of IMMULITE 2000 Cortisol, Folic Acid, and Vitamin B12 assays on IMMULITE 2000 systems. For prescription use only.
Regulatory Classification
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.
