510(k) · Cleared
Recalled · Class II · 2022Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Apr 18, 2011 as substantially equivalent to K012357 (Bayer Diagnostics Corp., 2002) and 1 other predicate after a 437-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 18, 2011
- Review
- 437 days
- Class
- Class II
- Product code
- MOI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963926 (1997). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK963926 Axsym CA 15-3Abbott Laboratories · 1997 · Recalled
- 2 generations backK033036 BR Monitor and BR Monitor Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2004 · Recalled
- 1 generation backK072612 Access Immunoassay Systems BR Monitor, and Calibrators, Model (S)…Beckman Coulter, Inc. · 2007 · Recalled
- This deviceK100344 Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics · 2011
- Descendant · cites it directly · 0 of its ownK122398 Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122398Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963926 | Axsym CA 15-3 | Abbott Laboratories | 1997 | 4 |
| −2 | K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2004 | 1 |
| −1 | K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and… | Beckman Coulter, Inc. | 2007 | 1 |
| 0 (this device) | K100344 | Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7… | Siemens Healthcare Diagnostics | 2011 | — |
| +1 | K122398 | Rapidpoint 500 System Measurement Cartridge with Calibrators | Siemens Healthcare Diagnostics, Inc. | 2012 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 MOI? 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 MOI device
- #1 K240403 Access BR Monitorscore 7.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K012357 | CA 15-3 Assay for the Advia Centaur SystemSummary page 1…device used to demonstrate substantial equivalence to the [OCI CA 15-3 Flex® Reagent Cartridge isthe CA 15-3 Assay for the AD VIA Centaur System previously cleared under K01 2357. The predicate device used to demonstrate substantial equivalence to the Dimension Vista® [OCI 7 Calibrator is the Calibrator fo… | 2002 |
| * | K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647Summary page 1…device used to demonstrate substantial equivalence to the Dimension Vista® [OCI 7 Calibrator is the Calibrator for the Access® BR Monitor Assay previously cleared under K072612. G. Device Description: The LOCI CA 15-3 (CA 15-3) method is a homogeneous, sandwich chemiluminescont immunoassa… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122398 | Rapidpoint 500 System Measurement Cartridge with Calibrators | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2022 | Class II | Z-1648-2022 | Under Investigation by firm | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K122398 (Siemens Healthcare Diagnostics, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012357.
How does its category compare?
All MOI devicesMOI System, Test, Immunological, Antigen, Tumor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MOI
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MOI
Too few MOI 510(k)s in any year since 2007 to give a median.
Recalls per year · MOI
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOI
6in 2025
MAUDE reports naming product code MOI, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 22 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100344: Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100344
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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