Elecsys Calcitonin

The Elecsys Calcitonin is an in vitro immunoassay that quantitatively measures human calcitonin in serum and plasma samples. It is used as an aid in diagnosing and treating thyroid and parathyroid gland diseases, including carcinoma and hyperparathyroidism. The assay uses electrochemiluminescence (ECLIA) technology and runs on cobas e immunoassay analyzers with an 18-minute test duration.

The updated Elecsys Calcitonin assay maintains the same sandwich principle format, quantitative test type, 18-minute application time, and 1-2000 pg/mL measuring range as the predicate. The primary change is improved biotin tolerance, increased from ≤40 ng/mL to ≤1200 ng/mL, addressing potential interference in samples from patients receiving biotin-containing supplements or medications.

Performance validation followed CLSI standards: EP05-A3 (precision), EP06-Ed2 (linearity), EP09-A3 (method comparison), EP17-A2 (analytical sensitivity limits), EP34 (dilution testing), and EP07-A3 (drug interference). Standardization is to WHO Reference Standard 89/620.

Substantial equivalence is established because the updated assay maintains identical intended use, test format, application time, and measuring range as the predicate Elecsys Calcitonin (K132828). All analytical performance specifications met predefined acceptance criteria, method comparison shows strong correlation (r=0.996), and the sole modification—enhanced biotin tolerance—represents a performance improvement with no safety or effectiveness concerns.