510(k) · Cleared
ClearedModification to Abuscreen Online Cocaine Metabolite
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 Dec 11, 1998 as substantially equivalent to K933053 (Roche Diagnostic Systems, Inc., 1993) after a 51-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933053 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK933053 Abuscreen Online (R) for Cocaine Metabolite, ModifRoche Diagnostic Systems, Inc. · 1993
- This deviceK983697 Modification to Abuscreen Online Cocaine MetaboliteRoche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK023281 Online Dat II Cocaine IIRoche Diagnostics Corp. · 2002
- Descendant · 2 generations on · 0 of its ownK062929 Quest Diagnostics Urine Cocaine Metabolite EiaQuest Diagnostics, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933053 | Abuscreen Online (R) for Cocaine Metabolite, Modif | Roche Diagnostic Systems, Inc. | 1993 | — |
| 0 (this device) | K983697 | Modification to Abuscreen Online Cocaine Metabolite | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K023281 | Online Dat II Cocaine II | Roche Diagnostics Corp. | 2002 | — |
| +2 | K062929 | Quest Diagnostics Urine Cocaine Metabolite Eia | Quest Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K933053 | Abuscreen Online (R) for Cocaine Metabolite, ModifSummary page 2…. claims equivalence. Table 2 Product Name Predicate Product 510(k) Number and Date Name Predicate Cleared Abuscreen ONLINE for Cocaine |Abuscreen ONLINE for Cocaine |K933053 8/30/93 Metabolite 028 Roche Diagnostic Systems, Inc. Abuscreen ONLINE® Cocaine Metabolite Somerville. New Jerse… | 1993 |
| † | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023281 | Online Dat II Cocaine II | 2002 | 1 |
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.
- Of its descendants, K023281 (Roche Diagnostics Corp., 2002) has gone furthest, with 1 descendant 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?
Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse.
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/K983697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983697: Modification to Abuscreen Online Cocaine Metabolite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983697
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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