# K991465: Drug Stop

- Pathway: 510(k) (Traditional)
- Applicant: Texas Immunology, Inc.
- Decided: Dec 10, 1999 after 227 days
- Product code: MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter)
- Device class: U
- 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
DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), MOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust). ) DrugStop is the first step in a tvo step testing proceas. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample MUST be sent to our reference lab for confirmation at no additional cost to the customer. Howme drug tests are not as accurate as lab tests and any PRELIMINARY results MUST BE CONFIRMED before any action is taken against the person being tested.

Source page: https://510kreport.com/device/K991465
Methodology: https://510kreport.com/methodology