# K012077: Immulite Rubella Igm,LKRM1, LKRM2, Immulite 2000 Rubella Igm, Model L2KRM2, L2KRM6

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 10, 2002 after 192 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K885300 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885300: Captia (R) Rubella-M, Mercia Diagnostics, Ltd. (1989) Summary page 1.

## Recalls of this device
- Aug 24, 2016 · Class II · Z-0081-2017: Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the I
- Aug 24, 2016 · Class II · Z-0082-2017: Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the I

## Indications for use
IMMULITE® Rubella IgM — For in vitro diagnostic use with the IMMULITE Analyzer - for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma (EDTA or heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age. IMMULITE 2000%® Rubella IgM — For in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma (EDTA or heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.

Source page: https://510kreport.com/device/K012077
Methodology: https://510kreport.com/methodology