510(k) · Cleared
ClearedDimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'S K6455, and KC604
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on Apr 12, 2011 as substantially equivalent to K020828 (Bayer Corp., 2002) and 2 other predicates after a 432-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Apr 12, 2011
- Review
- 432 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K981985 (1998). 10 ancestors in all, the oldest P820060 (1983). No later device cites it as a predicate yet.
- Root · 4 generations backK981985 Access Cea Reagents on the Access Immunoassay Analyzer Model 33200…Beckman Coulter, Inc. · 1998 · Recalled
- 3 generations backK991707 Modification to Access Cea Reagents for Use on the Access…Beckman · 1999
- 2 generations backK031270 Access Cea Reagents for Use on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2003 · Recalled
- 1 generation backK071603 Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
- This deviceK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981985 | Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205… | Beckman Coulter, Inc. | 1998 | 1 |
| −3 | K991707 | Modification to Access Cea Reagents for Use on the Access Immunoassay… | Beckman | 1999 | — |
| −2 | K031270 | Access Cea Reagents for Use on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2003 | 1 |
| −1 | K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) | Dade Behring, Inc. | 2008 | — |
| 0 (this device) | K100321 | Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6… | Siemens Healthcare Diagnostics | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LTK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LTK device
- #1 K240479 Access OV Monitorscore 7.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020828 | CA 125 Assay for the Advia Centaur SystemSummary page 2…em. 1. Substantial Equivalence Information: The LOCI CA 125111M method is substantially equivalent to other CA125 test systems such as the ADVIA Centaur CA12511 assay (k020828). The LOCI 6 calibrator is substantially equivalent to other calibrators such as the LOCI 5 calibrator (1<071597 and k071603). Th… | 2002 |
| * | K071597 | Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R)…Summary page 2…edicate device used to demonstrate substantial equivalence to the Dimension Vista®D LOCI 6 Calibrator is the Dimension Vista®D LOCI 5 Calibrator previously cleared under k071597 and k071603. G. Device Description: The LOCI CA 12511"'M method is a homogeneous, sandwich chemiluminescent immunoassay based o… | 2008 |
| * | K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Summary page 2…ce used to demonstrate substantial equivalence to the Dimension Vista®D LOCI 6 Calibrator is the Dimension Vista®D LOCI 5 Calibrator previously cleared under k071597 and k071603. G. Device Description: The LOCI CA 12511"'M method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® tech… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 5 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K020828.
How does its category compare?
All LTK devicesLTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LTK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LTK
Too few LTK 510(k)s in any year since 2007 to give a median.
Recalls per year · LTK
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTK
4in 2025
MAUDE reports naming product code LTK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 4 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 2 | — | 0 | 31 |
| 2010 | 0 | — | 3 | 12 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 33 |
| 2013 | 0 | — | 1 | 14 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 2 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (167 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100321 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100321: Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'S K6455, and KC604.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100321
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026