Anti-Human IgG Serum

510(k) Number

K791281 ↗

FDA Product Code

DEW

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K823348 Active Cleared 28 Dec 1982

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  FDA 510(k) K002756 Active Cleared 23 Feb 2001

• Buffer, Collagen Reagent and Diluent (JBX)

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  FDA 510(k) K781710 Active Cleared 24 Oct 1978

• Anti-Human Kappa Serum

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  FDA 510(k) K791284 Active Cleared 27 Nov 1979

• Diagnostic Kits & Kit Components

  Class I

  FDA 510(k) K812434 Active Cleared 23 Sep 1981

• Aspergillus Fumigatus, Aspergillus Flavu

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  FDA 510(k) K790672 Active Cleared 31 May 1979

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• What is the Anti-Human IgG Serum used for in clinical settings?

  The Anti-Human IgG Serum is designed for immunochemical testing in laboratory settings to detect and quantify human Immunoglobulin G (IgG) in plasma or serum samples. This helps diagnose conditions linked to abnormal IgG levels, such as autoimmune disorders or immunodeficiencies, by providing a reagent for precise diagnostic analysis.

• Is this product intended for single-use or can it be reused?

  The provided data does not explicitly state whether the Anti-Human IgG Serum is single-use or reusable. However, since it is classified as a reagent for in vitro diagnostic use in controlled laboratory environments, it is typically handled under strict protocols to ensure accuracy and sterility, which often aligns with single-use practices for diagnostic reagents.

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

  The Anti-Human IgG Serum received a Traditional 510(k) clearance (K791281) from the FDA in 1979, demonstrating it was determined to be *substantially equivalent* to a legally marketed predicate device. The clearance was granted under the product code DEW (Antigen, Antiserum, Control) and falls under FDA classification 866.5510, which categorizes it as a Class II device.

• How is the Anti-Human IgG Serum supplied, and what should be considered for storage?

  The data does not specify the exact form of supply (e.g., vial size, concentration, or packaging), but as a reagent for laboratory use, it is likely supplied in sterile, pre-measured aliquots or concentrated forms. Since it is used in controlled settings, storage should follow standard laboratory protocols for reagents—typically at recommended temperatures (often refrigerated or frozen) to maintain stability and prevent degradation until use.