(86 days)
Elecsys Calcitonin Immunoassay:
The Calcitonin Immunoasay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings.
Elecsys Calcitonin CalSet:
Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Elecsys and cobas e immunoassay analyzers.
Elecsys Calcitonin CalCheck 5:
The Elecsys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the calcitonin assay range established by the Elecsys and cobas e immunoassay analvzers.
Elecsys PreciControl Varia:
The Elecsys PreciControl Varia is used for quality control of the Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
The Calcitonin Assay employs monoclonal antibodies specifically directed against hCT. The antibodies labeled with a ruthenium complex and biotin, respectively consist of mouse-specific components.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
The Elecsys Calcitonin CalSet is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The Elecsys Calcitonin CalCheck 5 is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The PreciControl Varia is a multi-composite lyophilized 3 level control set which has been previously cleared (K111506), with added calcitonin analyte.
This document describes the specifications and comparative characteristics of the Elecsys Calcitonin Immunoassay and its associated calibrators and quality controls against predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance (Elecsys Calcitonin Immunoassay vs. Predicate Device)
| Feature | Predicate Device: Immulite 1000 Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay (New Device) |
|---|---|---|
| Intended Use | To measure calcitonin levels in serum for diagnosis and treatment of thyroid and parathyroid gland diseases. | Quantitative determination of human calcitonin in serum and plasma for diagnosis and treatment of thyroid and parathyroid gland diseases (including carcinoma and hyperparathyroidism) in conjunction with other clinical and laboratory findings. |
| Assay Protocol | Solid-phase, enzyme-labeled, two-site chemiluminescent immunometric assay; 2 x 30 minutes incubation, 60 minutes total duration. | Murine monoclonal antibodies (ruthenium complex and biotin labeled) directed against hCT. Streptavidin coated microparticles as solid phase. Sandwich principle. 18 minutes total duration. |
| Detection Protocol | Chemiluminescent Immunometric assay | Electrochemiluminescent Immunoassay |
| Instrument Platform | Immulite 1000 | cobas e 411 |
| Sample Volume | 75 µL | 50 µL |
| Sample Type | Human serum or heparinized plasma | Human serum and plasma treated with K2-EDTA, K3-EDTA, lithium heparin, and lithium heparin plasma gel separation tubes. |
| Calibrator | Siemens Calcitonin Adjustors (LCLL, LCLH) | Elecsys Calcitonin CalSet |
| Calibration Interval | Recommended: 4 weeks | Once per reagent lot (fresh reagent, |
§ 862.1140 Calcitonin test system.
(a)
Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).(b)
Classification. Class II.