# K033299: Acon Mamp One Step Methamphetamine Test Strip and Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Dec 12, 2003 after 59 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
82 later devices descend from it; 2 cite it directly.
0 of 83 devices 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) FDA-cleared Methamphetamine test with 500 ng/mL Methamphetamine cutoff: named in the summary without a submission number

## Most influential descendants
- K061718: Innovacon Spectrum II Test Card (2006), 80 descendants of its own
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (2018), 13 descendants of its own
- K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (2014), 13 descendants of its own

## Indications for use
The ACON® mAMP 500 One Step Methamphetamine Test Strip and Test Device are rapid immunochromatographic assays for the qualitative detection of methamphetamine, a central nervous stimulating drug, in urine. Measurements obtained by these devices are used in the diagnosis and treatment of methamphetamine use or overdose. This assay provides only a preliminary result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.

Source page: https://510kreport.com/device/K033299
Methodology: https://510kreport.com/methodology