510(k) · Cleared
ClearedDimension Tacr Calibrator, Model DC107
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 May 18, 2006 as substantially equivalent to P970007 (Abbott Laboratories, 1997) after an 83-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- May 18, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P970007 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backP970007 Imx Tacrolimus II AssayAbbott Laboratories · 1997 · Recalled
- This deviceK060503 Dimension Tacr Calibrator, Model DC107Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK150168 Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension…Siemens Healthcare Diagnostics · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC…Siemens Healthcare Diagnostics · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P970007 | Imx Tacrolimus II Assay | Abbott Laboratories | 1997 | 2 |
| 0 (this device) | K060503 | Dimension Tacr Calibrator, Model DC107 | Dade Behring, Inc. | 2006 | — |
| +1 | K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus… | Siemens Healthcare Diagnostics | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | P970007 | Imx Tacrolimus II AssaySummary page 1…Device Name I Classification Dimension®M TACR Calibrator /Class 1] 3. Identification of the Predicate Device Abbott IMx® Tacrolimus II Calibrators, P970007 (Note: Tacrolimus test systems have been reclassified into Class II since the predicate was approved.) 4. Dev… | 1997 |
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 |
|---|---|---|---|
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC… | 2015 | 0 |
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 Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to
calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060503: Dimension Tacr Calibrator, Model DC107.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060503
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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