# K981297: Immulite OM-MA, Models Lkopz, LKOP1, LKOP5

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Sep 18, 1998 after 163 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P85009: Centocor CA 125 II RIA. Number could not be read Summary page 1.

## Most influential descendants
- K983391: Immulite 2000 OM-MA Model L2KOP2 (1998), 2 descendants of its own
- K213510: Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MA (2023), 0 descendants of its own
- K072794: Immulite 2500 OM-MA, Model L5KOP (2007), 0 descendants of its own

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1682-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 

## Indications for use
IMMULITE OM-MA is a chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of CA 125 antigen in serum. It is intended strictly for in vitro diagnostic use 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.

Source page: https://510kreport.com/device/K981297
Methodology: https://510kreport.com/methodology