# K072794: Immulite 2500 OM-MA, Model L5KOP

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions Diagnostics
- Decided: Nov 5, 2007 after 35 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981297 (1998). 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)
- K983391: Immulite 2000 OM-MA Model L2KOP2, Diagnostic Products Corp. (1998) Summary page 2.

## Indications for use
Immulite 2500 OM-MA For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of CA125 antigen in human serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures Immulite Tumor Marker Controls TMC is an assayed, serum-based, tri-level control containing analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro use as an aid in monitoring the day-to-day performance of assays for these constituents.

Source page: https://510kreport.com/device/K072794
Methodology: https://510kreport.com/methodology