# K213510: Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MA

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products, Ltd.
- Decided: Sep 8, 2023 after 675 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)
- K981297: Immulite OM-MA, Models Lkopz, LKOP1, LKOP5, Diagnostic Products Corp. (1998) Summary page 4.
- K983391: Immulite 2000 OM-MA Model L2KOP2, Diagnostic Products Corp. (1998) Summary page 4.

## Indications for use
For in vitro diagnostic use with the IMMULITE® and IMMULITE® 1000 Analyzers — for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelian 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. For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelian 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.

Source page: https://510kreport.com/device/K213510
Methodology: https://510kreport.com/methodology