# K121122: Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid Control

- Pathway: 510(k) (Traditional)
- Applicant: Biochemical Diagnostic, Inc.
- Decided: Jul 3, 2012 after 81 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K153474: Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series (2016), 0 descendants of its own

## Indications for use
The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K121122
Methodology: https://510kreport.com/methodology