# K100321: Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'S K6455, and KC604

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 12, 2011 after 432 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: 4 generations back to K981985 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020828: CA 125 Assay for the Advia Centaur System, Bayer Corp. (2002) Summary page 2.
- K071597: Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model KC600, Dade Behring, Inc. (2008) Summary page 2.
- K071603: Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea), Dade Behring, Inc. (2008) Summary page 2.

## Indications for use
The LOCI CA 125 JITM method is an in vitro diagnostic test for the quantitative measurement of CA 125 antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 125 are used as an aid in monitoring disease progress or response to therapy or for the recurrent or residual disease for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is recommended that the LOCI CA 125 11method be used in conjunction with signs and symptoms of a clinical evaluation by a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system. The LOCI 6 CAL is an in vitro diagnostic product for the calibration of Alpha-Fetoprotein (AEP), Carcinoembryonic Antigen (CEA), and CA 125 (CAllS) methods on the Dimension Vista® System.

Source page: https://510kreport.com/device/K100321
Methodology: https://510kreport.com/methodology