The Complement C1 Inhibitor (Inactivator) Immunological Test System is a diagnostic assay intended for the quantitative measurement of C1 inhibitor (C1-INH) levels in human serum, often used to aid in diagnosing hereditary angioedema (HAE). This test plays a key role in assessing the deficiency or dysfunction of C1-INH, which is crucial in HAE, a rare genetic disorder that leads to episodes of severe swelling.

Intended Use of Ceruloplasmin Immunological Test System

A Complement C1 Inhibitor (Inactivator) Immunological Test System is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Intended Use

This device is an in vitro diagnostic assay designed for the quantitative measurement of human C1 inactivator (C1-INH) in human serum. This assay aids in diagnosing hereditary angioedema (HAE) by assessing C1-INH levels in conjunction with other clinical and laboratory findings.

Device Description

This device includes Sheep Antiserum for C1 Inactivator in stabilized liquid form with preservatives (0.099% sodium azide, 0.1% EACA, 0.1% EDTA, and 0.01% benzamidine), pooled human serum calibrator and controls with similar preservatives, and a reaction buffer containing 0.099% sodium azide.

The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed, a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.

• Precision (Reproducibility and Repeatability)
• Linearity
• Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
• Limit of Detection (LoD), Limit of Quantification (LoQ) and Limit of Blank (LoB)
• Analytical specificity
• Comparison Studies
• Expected Values/Reference Range
• Software verification and validation

Clinical Testing

No Guidance available  for 510k submission