# K011673: Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Jul 31, 2001 after 62 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
Longest line of descent: 1 generation back to K945610 (1995). 1 ancestor in all.
93 later devices descend from it; 4 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945610: Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp, Princeton BioMeditech Corp. (1995) Summary page 2.

## Most influential descendants
- K020313: Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test Device (2002), 88 descendants of its own
- K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card (2003), 83 descendants of its own
- 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

## Indications for use
The ACON AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of amphetamine in human urine at a cut-off concentration of 1,000 ng/mL. These tests are for professional and point of care use.

Source page: https://510kreport.com/device/K011673
Methodology: https://510kreport.com/methodology