Semi-Quantitative Assay for Det. of Igg and Igm

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K893897 ↗

FDA Product Code

LKJ

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Quantitative Assay for Det. of Igg Igm Anti-Dsdna

  Class II

  FDA 510(k) K893896 Active Cleared 14 Jul 1989

• Biostar* Reads* Immune Complex Assay Kit

  Class II

  FDA 510(k) K861499 Active Cleared 20 Jun 1986

• Reads RF Test Kit for IgM Rheumatoid Factor

  Class II

  FDA 510(k) K863238 Active Cleared 8 Oct 1986

• Biostar Re-a-Ds Immune Complex Assay Kit

  Class II

  FDA 510(k) K853697 Active Cleared 16 Dec 1985

• What is the Biostar IgG/IgM Semi-Quantitative Assay Kit used for?

  This assay kit is designed for the semi-quantitative detection of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies in patient samples. It supports diagnostic evaluations for autoimmune and infectious conditions by helping measure specific antibody levels, which can assist clinicians in identifying potential immune responses or infections.

• How is the Biostar IgG/IgM Semi-Quantitative Assay Kit supplied, and is it reusable?

  The kit is supplied as an in vitro diagnostic test for laboratory use and is intended for single-use only. It is not designed for reuse, and no information regarding reprocessing or sterilization for reuse is provided in the available data.

• Does the Biostar IgG/IgM Semi-Quantitative Assay Kit require any special storage conditions?

  The provided data does not specify storage conditions or shelf life for the Biostar IgG/IgM Semi-Quantitative Assay Kit. Users should refer to the manufacturer’s instructions for proper storage guidance, which may include temperature, humidity, or light exposure requirements.

• What regulatory status does the Biostar IgG/IgM Semi-Quantitative Assay Kit hold?

  The kit is regulated under the FDA’s 510(k) clearance process and holds clearance number K893897. It is classified as a Class II device under regulation number 866.5100, indicating it has been deemed substantially equivalent to a predicate device through a traditional review pathway.

• Can this assay be used outside of a laboratory setting?

  No, the Biostar IgG/IgM Semi-Quantitative Assay Kit is intended for in vitro diagnostic use in a laboratory setting only. It requires laboratory processing, which typically includes controlled environments, trained personnel, and appropriate equipment for accurate and reliable results.