510(k) · Cleared
ClearedDimension Vista System Ecstasy Calibrator, Model KC520
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 14, 2006 as substantially equivalent to K043028 (Dade Behring, Inc., 2005) after a 45-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Sep 14, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010496 (2001). 5 ancestors in all, the oldest K983159 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK010496 Cedia Dau Amphetamines/Ecstasy AssayMicrogenics Corp. · 2001
- 2 generations backK012110 Dri Ecstasy Enzyme ImmunoassayMicrogenics Corp. · 2001
- 1 generation backK043028 Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005
- This deviceK062182 Dimension Vista System Ecstasy Calibrator, Model KC520Dade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010496 | Cedia Dau Amphetamines/Ecstasy Assay | Microgenics Corp. | 2001 | — |
| −2 | K012110 | Dri Ecstasy Enzyme Immunoassay | Microgenics Corp. | 2001 | — |
| −1 | K043028 | Emit II Plus Ecstasy Assay | Dade Behring, Inc. | 2005 | — |
| 0 (this device) | K062182 | Dimension Vista System Ecstasy Calibrator, Model KC520 | Dade Behring, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K043028 | Emit II Plus Ecstasy AssaySummary page 2…nsion VistaTM System. I. Substantial Equivalence Information: 1. Predicate Device: SYVA® EMIT® II Plus Ecstasy Calibrators/Controls cleared under K043028. 2. Comparison with Predicate: New Device Predicate Device… | 2005 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K043028.
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 EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062182: Dimension Vista System Ecstasy Calibrator, Model KC520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062182
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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