C3 Antiserum Control

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K834604 ↗

FDA Product Code

CZW

Device Class

Class II

Regulation

21 CFR Part 866.5240

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the C3 Antiserum Control in a laboratory setting?

  The C3 Antiserum Control is designed as a reference standard for immunological testing of complement component C3. It ensures the accuracy and reliability of assays measuring C3 antigen levels in serum or plasma samples, which is critical for supporting diagnostic procedures in immunology.

• Is the C3 Antiserum Control intended for single-use or repeated use in testing?

  The C3 Antiserum Control is explicitly supplied as a sterile, liquid reagent intended for single-use only in laboratory settings. This prevents cross-contamination and maintains the integrity of the control material for accurate assay validation.

• How should the C3 Antiserum Control be stored to preserve its effectiveness?

  While specific storage instructions aren’t detailed in the data, standard laboratory protocols for immunological reagents should be followed. This typically includes refrigeration (e.g., 2–8°C) and protection from light, as with most liquid controls, to maintain stability and sterility.

• What regulatory pathway was followed for FDA clearance of this device?

  The C3 Antiserum Control received FDA 510(k) clearance under the Traditional pathway in 1984, classified as *Substantially Equivalent (SESE)* to a predicate device. It falls under FDA regulation 866.5240 and was reviewed by the Immunology (IM) Advisory Committee.

• Are there multiple sizes or models of this control available?

  The provided data does not specify varying sizes or models of the C3 Antiserum Control. It is described as a single product (product code CZW) without differentiation by volume or formulation, so it appears to be offered uniformly for standard use in C3 antigen assays.