# K991516: Micro-Strip for Marijuana Metabolites

- Pathway: 510(k) (Traditional)
- Applicant: Microdiagnostics, Inc.
- Decided: Aug 5, 1999 after 97 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
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 MICRO-STRIP FOR MARIJUANA METABOLITES is an immunoassay that qualitatively detects the major Marijuana metabolites (tetrahydrocannabinoids/THC) in urine at the SAMHSA cutoff level of 50 ng/ml. The MICRO-STRIP FOR MARIJUANA METABOLITES is Intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics and law enforcement agencies only.

Source page: https://510kreport.com/device/K991516
Methodology: https://510kreport.com/methodology