# K963916: Immulite Cannabinoids

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Apr 28, 1997 after 210 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930007 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961620: Abiscreen Online for Cannabinoids - ES 50/100, Roche Diagnostic Systems, Inc. (1996) Summary page 2.
- K930007: Immulite TSH Third Generation Control, Diagnostic Products Corp. (1993) Summary page 2.

## Cited in the summary but kept off the family tree
- K951288: Axsym Cannabinoids, Abbott Laboratories (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
IMMULITE® Cannabinoids is a solid-phase. chemiluminescent enzyme immunoassay designed for use with the IMMULITE" Automated Analyzer for the semiquantitative and qualitative measurement for cannabinoids and metabolites in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for tetrahydrocannabinol (THC. cannabis. marijuana) and its metabolites

Source page: https://510kreport.com/device/K963916
Methodology: https://510kreport.com/methodology