# K983391: Immulite 2000 OM-MA Model L2KOP2

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Oct 15, 1998 after 20 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
Longest line of descent: 1 generation back to K981297 (1998). 1 ancestor in all.
2 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)
- K981297: Immulite OM-MA, Models Lkopz, LKOP1, LKOP5, Diagnostic Products Corp. (1998) Summary page 1.

## Most influential descendants
- 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-1683-2018: 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® 2000 OM-MA is a solid-phase, chemiluminescent enzyme immunometric assay for use with the IMMULITE® 2000 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/K983391
Methodology: https://510kreport.com/methodology