# K100344: Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 18, 2011 after 437 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- 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: 3 generations back to K963926 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012357: CA 15-3 Assay for the Advia Centaur System, Bayer Diagnostics Corp. (2002) Summary page 1.
- K072612: Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647, Beckman Coulter, Inc. (2007) Summary page 1.

## Most influential descendants
- K122398: Rapidpoint 500 System Measurement Cartridge with Calibrators (2012), 0 descendants of its own

## Recalls of this device
- Jul 18, 2022 · Class II · Z-1648-2022: Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.

## Indications for use
The LOCI CA 15-3 method is an in vitro diagnostic test for the quantitative measurement of CA 15-3 in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. When used in conjunction with other clinical and diagnostic procedures, serial testing with the LOCI CA 15-3 assay may be used as an aid in the management of previously treated stage II and III breast cancer patients and for monitoring response to therapy in metastatic breast cancer patients. The LOCI 7 CAL is an in vitro diagnostic product for the calibration of Cancer Antigen 15-3 (CA 15-3) and Cancer Antigen 19-9 (CA 19-9) methods on the Dimension Vista® system.

Source page: https://510kreport.com/device/K100344
Methodology: https://510kreport.com/methodology