510(k) · Cleared
ClearedOnline Dat II Cocaine II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Dec 6, 2002 as substantially equivalent to K983697 (Roche Diagnostic Systems, Inc., 1998) after a 66-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Dec 6, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933053 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK933053 Abuscreen Online (R) for Cocaine Metabolite, ModifRoche Diagnostic Systems, Inc. · 1993
- 1 generation backK983697 Modification to Abuscreen Online Cocaine MetaboliteRoche Diagnostic Systems, Inc. · 1998
- This deviceK023281 Online Dat II Cocaine IIRoche Diagnostics Corp. · 2002
- Descendant · cites it directly · 0 of its ownK062929 Quest Diagnostics Urine Cocaine Metabolite EiaQuest Diagnostics, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062929Quest Diagnostics Urine Cocaine Metabolite EiaQuest Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933053 | Abuscreen Online (R) for Cocaine Metabolite, Modif | Roche Diagnostic Systems, Inc. | 1993 | — |
| −1 | K983697 | Modification to Abuscreen Online Cocaine Metabolite | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K023281 | Online Dat II Cocaine II | Roche Diagnostics Corp. | 2002 | — |
| +1 | K062929 | Quest Diagnostics Urine Cocaine Metabolite Eia | Quest Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 DIO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K983697 | Modification to Abuscreen Online Cocaine MetaboliteSummary page 2…ocaine and cocaine metabolites 3) Predicate We claim substantial equivalence to the currently marketed Abuscreen device OnLine Cocaine Metabolite assay (K983697). Continued on next page… | 1998 |
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 |
|---|---|---|---|
| K062929 | Quest Diagnostics Urine Cocaine Metabolite Eia | 2006 | 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062929 (Quest Diagnostics, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cocaine II is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K023281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023281: Online Dat II Cocaine II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023281
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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