510(k) · Cleared
ClearedQuest Diagnostics Urine Cocaine Metabolite Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Diagnostics, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Dec 18, 2006 as substantially equivalent to K023281 (Roche Diagnostics Corp., 2002) after an 81-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Dec 18, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933053 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK933053 Abuscreen Online (R) for Cocaine Metabolite, ModifRoche Diagnostic Systems, Inc. · 1993
- 2 generations backK983697 Modification to Abuscreen Online Cocaine MetaboliteRoche Diagnostic Systems, Inc. · 1998
- 1 generation backK023281 Online Dat II Cocaine IIRoche Diagnostics Corp. · 2002
- This deviceK062929 Quest Diagnostics Urine Cocaine Metabolite EiaQuest Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933053 | Abuscreen Online (R) for Cocaine Metabolite, Modif | Roche Diagnostic Systems, Inc. | 1993 | — |
| −2 | K983697 | Modification to Abuscreen Online Cocaine Metabolite | Roche Diagnostic Systems, Inc. | 1998 | — |
| −1 | K023281 | Online Dat II Cocaine II | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K062929 | Quest Diagnostics Urine Cocaine Metabolite Eia | Quest Diagnostics, Inc. | 2006 | — |
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 3.1 · 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? (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 |
|---|---|---|---|
| * | K023281 | Online Dat II Cocaine IISummary page 1…fication Number: 862.3250 Substantially Equivalent Device: Product: DAT 11 Cocaine II Manufactured by: Roche Diagnostics Cooperation 510(k) Number: K023281 Product Description: Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay… | 2002 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a 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 Quest Diagnostics Urine Cocaine Metabolite EIA is intended for the qualitative detection of benzovlecqonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers. It is a screen test with cutoffs of 300 np/ml and 150 nq/mI of benzovlecqonine per ml of urine. This test is intended for laboratory use only. For in vitro diagnostic use. The Quest Diagnostics Urine Cocaine Metabolite EIA provides only a preliminary…
Read the full statement (192 words)
The Quest Diagnostics Urine Cocaine Metabolite EIA is intended for the qualitative detection of benzovlecqonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers. It is a screen test with cutoffs of 300 np/ml and 150 nq/mI of benzovlecqonine per ml of urine. This test is intended for laboratory use only. For in vitro diagnostic use.
The Quest Diagnostics Urine Cocaine Metabolite EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
The Quest Diagnostics Urine Cocaine Metabolite EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Urine Cocaine Metabolite EIA to establish points of reference that are used in the determination of values in the measurement of benzoVlecqonine in urine.
The Quest Diagnostics Urine Cocaine Metabolite EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for benzoylecgonine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062929: Quest Diagnostics Urine Cocaine Metabolite Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062929
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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