Immulite 2000 Tobramycin, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests)

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests)

510(k) Number

K012312 ↗

FDA Product Code

KLB

Device Class

Class II

Regulation

21 CFR Part 862.3900

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the Immulite 2000 Tobramycin assay used for?

  The Immulite 2000 Tobramycin assay is a solid-phase, chemiluminescent competitive immunoassay designed for the quantitative measurement of tobramycin levels in patient serum or plasma. It supports clinical toxicology assessments by enabling precise detection of tobramycin concentrations, helping clinicians monitor drug levels and manage potential toxicity risks.

• How is the Immulite 2000 Tobramycin assay supplied, and what are the kit sizes?

  The assay is supplied as single-use reagent kits exclusively for use with the Immulite 2000 Automated Analyzer. Two configurations are available: the L2KTC2 kit contains 2002 tests, while the L2KTC6 kit contains 600 tests. Each kit is intended for one-time use to ensure reagent integrity and accuracy.

• Is the Immulite 2000 Tobramycin assay sterile, and how should it be stored?

  The Immulite 2000 Tobramycin assay is supplied as a single-use reagent kit, which implies it is intended for sterile use per standard immunoassay practices. Storage must adhere strictly to the manufacturer’s guidelines to preserve reagent integrity. Improper storage conditions, such as exposure to extreme temperatures or light, may compromise assay performance and should be avoided.

• Can the Immulite 2000 Tobramycin assay be reused, and what are its compatibility considerations?

  The Immulite 2000 Tobramycin assay is designed for single-use only, as indicated by its kit configuration. It is not compatible with MRI environments, and reuse is not supported by the manufacturer. The assay operates exclusively with the Immulite 2000 Automated Analyzer, ensuring compatibility and optimal performance.

• What regulatory pathway does the Immulite 2000 Tobramycin assay follow?

  The Immulite 2000 Tobramycin assay was granted a Substantially Equivalent (SESE) determination via a 510(k) clearance (K012312) by the FDA in 2001. It falls under the classification of radioimmunoassays for tobramycin and is regulated under FDA code 862.3900. The device was reviewed by the Clinical Toxicology Advisory Committee.