# K011609: Livesure Amphetamine Screen Test

- Pathway: 510(k) (Traditional)
- Applicant: Pan Probe Biotech, Inc.
- Decided: Jun 8, 2001 after 14 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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) EMIT® II Assay: named in the summary without a submission number

## Indications for use
The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for detection of D-Amphetamine (AMP) in human urine at the at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1000 ng AMP/m. Ihese tests are intended for visual, qualitative IVD screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. These screen tests for Amphetamine, analogs and metabolites provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA. have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment chould be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K011609
Methodology: https://510kreport.com/methodology