# K012075: Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model L2KTM2 and L2KTM6

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 10, 2002 after 192 days
- Product code: LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913787 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923166: Vidas Toxoplasma Gondii Igm Asssay, Biomerieux Vitek, Inc. (1993) Summary page 1.
- K913787: Toxoplasma Igm Elisa Test System, Zeus Scientific, Inc. (1991) Summary page 1.

## Indications for use
IMMULITE® Toxoplasma IgM - For in vitro diagnostic use with the IMMULITE® Analyzers — for the presumptive qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, particularly for women of childbearing age. When performed in conjunction with a Toxoplasma IgG assay, the IMMULITE® Toxoplasma IgM can be used as an aid in the presumptive diagnosis of acute, recent or reactive Toxoplasma gondii infection. This product has not been cleared/approved by the FDA for blood/plasma donor screening. IMMULITE® 2000 Toxoplasma IgM - For in vitro diagnostic use with the MMULITE® 2000 Analyzers — for the presumptive qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, particularly for women of childbearing age. When performed in conjunction with a Toxoplasma IgG assay, the IMMULITE® 2000 Toxoplasma IgM can be used as an aid in the presumptive diagnosis of acute, recent or reactive Toxoplasma gondii infection. This product has not been cleared/approved by the FDA for blood/plasma donor screening.

Source page: https://510kreport.com/device/K012075
Methodology: https://510kreport.com/methodology