# K053035: Acro Biotech LLC Rapid Benzoylecgonine Urine Test; Catalog# MET001000

- Pathway: 510(k) (Traditional)
- Applicant: Acro Biotech, LLC
- Decided: May 5, 2006 after 190 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in human urine at a cutoff of 300 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Source page: https://510kreport.com/device/K053035
Methodology: https://510kreport.com/methodology