510(k) · Cleared
ClearedDimension Extended Range Cyclosporine Calibrator, Catalog # DC108
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DLJ Calibrators, Drug Specific
Cleared on Sep 12, 2005 as substantially equivalent to K011112 (Dade Behring, Inc., 2001) after a 48-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Sep 12, 2005
- Review
- 48 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011112 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK011112 Cyclosporine CalibratorDade Behring, Inc. · 2001
- This deviceK052015 Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108Dade Behring, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK053108 Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108Dade Behring, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK061503 Dimension Cyclosporine Extended Range Calibrator (DC108A)Dade Behring, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK082030 Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K053108Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108Dade Behring, Inc. · 2006 · cites it directly2descendants
- K061503Dimension Cyclosporine Extended Range Calibrator (DC108A)Dade Behring, Inc. · 2006 · cites it directly1descendant
- K082030Dimension Vista Csae Calibrator, Model KC440Siemens Healthcare Diagnostics, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011112 | Cyclosporine Calibrator | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K052015 | Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108 | Dade Behring, Inc. | 2005 | — |
| +1 | K053108 | Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108 | Dade Behring, Inc. | 2006 | — |
| +1 | K061503 | Dimension Cyclosporine Extended Range Calibrator (DC108A) | Dade Behring, Inc. | 2006 | — |
| +2 | K082030 | Dimension Vista Csae Calibrator, Model KC440 | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 DLJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K011112 | Cyclosporine Calibrator | 2001 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DLJ devicesDLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DLJ
Too few DLJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLJ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLJ
3in 2025
MAUDE reports naming product code DLJ, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CSAE Calibrator is an in vitro diagnostic product intended to be used to calibrate the Cyctosporine Extended Range (CSAE) method for the Dimension® clinical chemistry system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052015: Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052015
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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