# K050593: Acon Bar II One Step Barbiturates Test Strip & Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: May 6, 2005 after 59 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K052197: First Sign Drug of Abuse Urine Screening Test (2006), 0 descendants of its own

## Indications for use
The ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of Barbiturates levels in urine at a designated cutoff concentration of 300 ng/mL (Secobarbital). They are intended for healthcare professionals including professionals at point-of-care sites. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K050593
Methodology: https://510kreport.com/methodology