510(k) · Cleared
ClearedDimension Csae Cyclosporine Extended Range Calibrator, Model 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 Feb 16, 2006 as substantially equivalent to K052015 (Dade Behring, Inc., 2005) after a 104-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Feb 16, 2006
- Review
- 104 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011112 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011112 Cyclosporine CalibratorDade Behring, Inc. · 2001
- 1 generation backK052015 Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108Dade Behring, Inc. · 2005
- This deviceK053108 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011112 | Cyclosporine Calibrator | Dade Behring, Inc. | 2001 | — |
| −1 | K052015 | Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108 | Dade Behring, Inc. | 2005 | — |
| 0 (this device) | 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 | 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 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 |
|---|---|---|---|
| * | K052015 | Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108Summary page 1…E Cyclosporine Extended Range Calibrator / Class II 3. Identification of the Predicate Device Dimension® CSAE Cyclosporine Extended Range Calibrator, K052015 4. Device Description The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061503 | Dimension Cyclosporine Extended Range Calibrator (DC108A) | 2006 | 1 |
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 5 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061503 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K052015.
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 Cyclosporine A, Extended Range (CSAE) method for the Dimension® clinical chemistry system or the Syva® Emit® 2000 Cyclosporine Specific Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053108: Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053108
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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