# K012300: Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Sep 17, 2001 after 59 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- 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 K991079 (1999). 1 ancestor in all.
92 later devices descend from it; 5 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991079: Accusign Bzo, Biosign Bzo, Status Bzo, Princeton BioMeditech Corp. (1999) Summary page 2.

## Most influential descendants
- K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device (2003), 86 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 BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzodiazepines in human urine at a cut-off concentration of 300 ng/mL set relative to oxazepam, a major metabolite of benzodiazepines. They are intended for healthcare professionals including professionals at point of care sites.

Source page: https://510kreport.com/device/K012300
Methodology: https://510kreport.com/methodology