510(k) · Cleared
ClearedPreciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DKB Calibrators, Drug Mixture
Cleared on May 30, 2006 as substantially equivalent to K031775 (Roche Diagnostics Corp., 2003) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 30, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951595 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995 · Recalled
- 1 generation backK031775 Preciset Dat Plus I CalibratorsRoche Diagnostics Corp. · 2003
- This deviceK060645 Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative…Roche Diagnostics Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951595 | Roche Cobas Integra Analyzer, Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1995 | 7 |
| −1 | K031775 | Preciset Dat Plus I Calibrators | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K060645 | Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus… | Roche Diagnostics Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 DKB? 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? (2)
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 |
|---|---|---|---|
| * | K031775 | Preciset Dat Plus I CalibratorsSummary page 1…Predicate We claim substantial equivalence to the currently marketed Roche calibrators: devices Preciset DAT Plus I calibrators, cleared in 5 10(k) K03 1775 and Preciset DAT Plus II and Cfas DAT Qualitative Plus cleared in 510(k) K033306.… | 2003 |
| * | K033306 | Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsSummary page 1…Preciset DAT Plus I calibrators, cleared in 5 10(k) K03 1775 and Preciset DAT Plus II and Cfas DAT Qualitative Plus cleared in 510(k) K033306. Continued on next page… | 2003 |
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 11 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K031775.
How does its category compare?
All DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DKB
Too few DKB 510(k)s in any year since 2007 to give a median.
Recalls per year · DKB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKB
1in 2017
MAUDE reports naming product code DKB, 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 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 2 | 1 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060645: Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060645
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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