# K032903: Acon Coc-150 One Step Cocaine Test Strip & Acon Coc-150 One Step Cocaine Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Feb 17, 2004 after 153 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
81 later devices descend from it; 1 cites it directly.
0 of 82 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 cocaine test with 150 ng/mL benzoylecgonine 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 COC-150 One Step Cocaine Test Strip and ACON COC-150 One Step Cocaine Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzoylecgonine levels in urine at a designated cutoff concentration of 150 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

Source page: https://510kreport.com/device/K032903
Methodology: https://510kreport.com/methodology