510(k) · Cleared
ClearedAbuscreen Online (R) for Cocaine Metabolite, Modif
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Aug 30, 1993 after a 96-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 30, 1993
- Review
- 96 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK933053 Abuscreen Online (R) for Cocaine Metabolite, ModifRoche Diagnostic Systems, Inc. · 1993
- Descendant · cites it directly · 2 of its ownK983697 Modification to Abuscreen Online Cocaine MetaboliteRoche Diagnostic Systems, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK023281 Online Dat II Cocaine IIRoche Diagnostics Corp. · 2002
- Descendant · 3 generations on · 0 of its ownK062929 Quest Diagnostics Urine Cocaine Metabolite EiaQuest Diagnostics, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K983697Modification to Abuscreen Online Cocaine MetaboliteRoche Diagnostic Systems, Inc. · 1998 · cites it directly2descendants
- K023281Online Dat II Cocaine IIRoche Diagnostics Corp. · 2002 · 2 generations on1descendant
- K062929Quest Diagnostics Urine Cocaine Metabolite EiaQuest Diagnostics, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K023281 | Online Dat II Cocaine II | Roche Diagnostics Corp. | 2002 | — |
| +3 | K062929 | Quest Diagnostics Urine Cocaine Metabolite Eia | Quest Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 3.1 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983697 | Modification to Abuscreen Online Cocaine Metabolite | 1998 | 2 |
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?
- Of its descendants, K983697 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K933053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933053: Abuscreen Online (R) for Cocaine Metabolite, Modif.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933053
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026