510(k) · Cleared
ClearedCocaine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Mar 13, 2002 as substantially equivalent to K902579 (Syva Co., 1990) after a 188-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Mar 13, 2002
- Review
- 188 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902579 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902579 Emit (R) II Cocaine Metabolite AssaySyva Co. · 1990
- This deviceK013004 CocaineAbbott Laboratories · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902579 | Emit (R) II Cocaine Metabolite Assay | Syva Co. | 1990 | — |
| 0 (this device) | K013004 | Cocaine | Abbott Laboratories | 2002 | — |
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 |
|---|---|---|---|
| * | K902579 | Emit (R) II Cocaine Metabolite AssaySummary page 2…imen can be measured in terms of enzyme activity. Substantial Equivalence: The Cocaine assay is substantially equivalent to the Emit® Tl Cocaine assay (K902579) on the SYva®- 30R Analyzer. ’ Both assays yicld similar Perforinance Characteristics. Similarities: « Both assays are in vitr… | 1990 |
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 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?
The Cocaine assay is used for the qualitative analysis of benzolecgonine (cocaine metabolite) in human urine with a cutoff of 300 ng/mL for use in clini¢al laboratories. Measurements obtained by this device arc used in the diagnosis and treatment of cocaine use or overdose. The Cocaine assay is calibrated with Benzoylccgonine and will detect cocaine and the major metabolites. The Cocaine assay provides only a preliminary analytical test result. A more…
Read the full statement (117 words)
The Cocaine assay is used for the qualitative analysis of benzolecgonine (cocaine metabolite) in
human urine with a cutoff of 300 ng/mL for use in clini¢al laboratories. Measurements obtained
by this device arc used in the diagnosis and treatment of cocaine use or overdose.
The Cocaine assay is calibrated with Benzoylccgonine and will detect cocaine and the major
metabolites.
The Cocaine assay provides only a preliminary analytical test result. A more specific alternate
chemical method must be used in order to obtain a confirtned analytical result. Gas
chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical
consideration and professional judgment should be applied to any drug of abuse test resulr,
particularly when preliminary positive results are used.
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/K013004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013004: Cocaine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013004
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026