# K013778: Peace of Mind Home Drug Test

- Pathway: 510(k) (Traditional)
- Applicant: Advantage Diagnostics Corp.
- Decided: Feb 7, 2002 after 86 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. The FDA summary names its predicate without a number.
- (no number) Phamatec QuickScreen™ At Home Test: named in the summary without a submission number
- (no number) Drug Stop Test: named in the summary without a submission number

## Indications for use
The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations: THC 50ng/mL . PCP 25ng/mL Opiates 2000ng/mL Cocaine 300ng/mL Methamphetamine 1000ng/mL The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.

Source page: https://510kreport.com/device/K013778
Methodology: https://510kreport.com/methodology