510(k) · Cleared
ClearedDimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and KC516
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DIF Drug Mixture Control Materials
Cleared on Aug 21, 2006 as substantially equivalent to K950138 (E.I. Dupont DE Nemours & Co., Inc., 1995) after a 21-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 21, 2006
- Review
- 21 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950138 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950138 Drugs of Abuse ControlsE.I. Dupont DE Nemours & Co., Inc. · 1995
- This deviceK062191 Dimension Vista System Drugs of Abuse Positive and Negative…Dade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950138 | Drugs of Abuse Controls | E.I. Dupont DE Nemours & Co., Inc. | 1995 | — |
| 0 (this device) | K062191 | Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models… | Dade Behring, Inc. | 2006 | — |
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 DIF? 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 |
|---|---|---|---|
| * | K950138 | Drugs of Abuse ControlsSummary page 3…ositive Control (DC43A) and the Dimension® Drugs of Abuse Negative Control (DC44A), both products cleared under K950138. The following table summarizes product similarities and differences: _________… | 1995 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, 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 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dimension VistaTM System Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista TM System. The Dimension VistaTM System Drugs of Abuse Negative Control is an in vitro diagnostic…
Read the full statement (95 words)
The Dimension VistaTM System Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista TM System.
The Dimension VistaTM System Drugs of Abuse Negative Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METIL), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062191: Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and KC516.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062191
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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