510(k) · Cleared
ClearedImmunalysis Cocaine Elisa for Hair
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 Aug 4, 2005 after a 154-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 4, 2005
- Review
- 154 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 Kit for Hair test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine in head hair samples using a cutoff of 500 pg/mg (0.5 ng/mg) of hair for the purpose of identifying chronic cocaine use. This process has not been evaluated for use with hair specimens other than head. This in vitro diagnostic device is intended for clinical laboratory use only. The Immunalysis Cocaine ELISA Kit…
Read the full statement (132 words)
The Immunalysis Cocaine ELISA Kit for Hair test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine in head hair samples using a cutoff of 500 pg/mg (0.5 ng/mg) of hair for the purpose of identifying chronic cocaine use. This process has not been evaluated for use with hair specimens other than head. This in vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Cocaine ELISA Kit for Hair test system provides only a preliminary analytical test result. For confirmation of the results, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in electron impact mode and using deuterated internal standards. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050465: Immunalysis Cocaine Elisa for Hair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050465
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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