# K051626: Immunalysis Opiates Elisa for Oral Fluids

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Oct 13, 2005 after 115 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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 Opiates ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Opiates in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISAL TM ORAL FLUID COLLECTION DEVICE ONLY using a cutoff of 40 ng/mL of Morphine. This in vitro diagnostic device is intended for clinical laboratory use only. The Immunalysis Opiates ELISA Kit for Oral Fluids 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/K051626
Methodology: https://510kreport.com/methodology