Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model L2KTM2 and L2KTM6

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

510(k) Number

K012075 ↗

FDA Product Code

LGD

Models / Variants

LKTM1

LKTM2

Immulite 2000 Toxoplasma Igm

Model L2KTM2

L2KTM6

Device Class

Class II

Regulation

21 CFR Part 866.3780

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Immulite Toxoplasma IgM test kit used for?

  The Immulite Toxoplasma IgM test kit is an Enzyme Linked Immunoabsorbent Assay designed to detect IgM antibodies to Toxoplasma gondii in human serum, aiding in the identification of recent or acute infection.

• Which immunoassay systems is the Immulite Toxoplasma IgM kit compatible with?

  The device is supplied as a diagnostic test kit for use with the Immulite and Immulite 2000 immunoassay systems, requiring these platforms to perform the antibody detection assay.

• Is the Immulite Toxoplasma IgM test kit supplied sterile or non-sterile, and is it for single use?

  The test kit components are not described as sterile in the provided data, and as a reagent-based immunoassay kit, it is intended for single-use testing runs; reagents are consumed during the assay and not meant for reuse.

• What models or references are included in the Immulite Toxoplasma IgM test kit?

  The kit includes model numbers LKTM1 and LKTM2 for the Immulite system, and L2KTM2 and L2KTM6 for the Immulite 2000 system, distinguishing the specific configurations for each platform.

• How should the Immulite Toxoplasma IgM test kit be stored based on the provided information?

  While specific storage conditions are not detailed in the device data, diagnostic test kits of this type typically require refrigerated storage (2–8°C) to maintain reagent stability until the expiration date, as is standard for immunoassay reagents.