Immulite Rubella Quantitative IgG, Catalog # LKRBQ1 (100 Tests), LKRBQ5 (500 Tests)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K982078 ↗

FDA Product Code

LFX

Device Class

Class II

Regulation

21 CFR Part 866.3510

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Immulite Rubella Quantitative IgG kit used for?

  This kit uses a solid-phase chemiluminescent immunoassay to measure IgG antibodies against the rubella virus in human serum. It helps determine whether a patient has immunity to rubella, particularly important for women of childbearing age to assess susceptibility to infection during pregnancy. The results provide objective data to guide clinical decisions about vaccination or infection risk.

• How is the Immulite Rubella IgG kit supplied, and is it single-use?

  The kit is supplied as a single-use reagent kit, available in two configurations: LKRBQ1 for 100 tests and LKRBQ5 for 500 tests. Since it is designed for in vitro diagnostic use on the Immulite Automated Analyzer, each kit is intended for one-time use per its labeled capacity. No additional sterilization is required, as the kit is pre-packaged for laboratory use.

• What storage and handling requirements apply to the Immulite Rubella IgG kit?

  The kit must be stored and handled according to standard protocols for in vitro diagnostic devices. While specific storage conditions (e.g., temperature) are not detailed here, it is critical to follow the manufacturer’s instructions included with the kit to maintain reagent integrity. Improper storage could compromise assay accuracy, so adherence to recommended guidelines is essential for reliable results.

• Are there different sizes or models available for the Immulite Rubella IgG kit?

  Yes, the kit is available in two distinct sizes: LKRBQ1 for 100 tests and LKRBQ5 for 500 tests. The choice between models depends on laboratory volume and testing needs. Both versions are compatible with the Immulite Automated Analyzer and share the same assay methodology, ensuring consistency across different kit sizes.

• What regulatory pathway does the Immulite Rubella IgG kit follow?

  The kit is classified as a Class II medical device under FDA 510(k) clearance (K982078) and falls under product code LFX for microbiology applications. It was determined to be substantially equivalent to a predicate device through a traditional review process by the FDA’s Microbiology (MI) Advisory Committee. This classification reflects its use in clinical microbiology settings for diagnostic purposes.