510(k) · Cleared
ClearedImmunalysis Cocaine/Cocaine Metabolite Elisa for Oral Fluids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunalysis Corporation · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Nov 18, 2005 after a 157-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 18, 2005
- Review
- 157 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 Immunalysis Cocaine ELISA test system utilizes an Enzyme Linked hnmunoassay (ELISA) for the qualitative detection of cocaine and cocaine metabolites at a cutoff of 20 ng/mL in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISALTM ORAL FLUID COLLECTION DEVICE ONLY. This in-vitro diagnostic device is intended for clinical laboratory use only. The Immunalysis Cocaine/Cocaine metabolite ELISA Kit provides only a preliminary analytical test result. A more…
Read the full statement (112 words)
The Immunalysis Cocaine ELISA test system utilizes an Enzyme Linked hnmunoassay (ELISA) for the qualitative detection of cocaine and cocaine metabolites at a cutoff of 20 ng/mL in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISALTM ORAL FLUID COLLECTION DEVICE ONLY. This in-vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Cocaine/Cocaine metabolite ELISA Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method. Clinical and Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051578: Immunalysis Cocaine/Cocaine Metabolite Elisa for Oral Fluids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051578
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026