# K051578: Immunalysis Cocaine/Cocaine Metabolite Elisa for Oral Fluids

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Nov 18, 2005 after 157 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K051578
Methodology: https://510kreport.com/methodology