# K132688: Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZ

- Pathway: 510(k) (Traditional)
- Applicant: Biochemical Diagnostics, Inc.
- Decided: Dec 16, 2013 after 110 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
Longest line of descent: 3 generations back to K924446 (1992). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103227: Oratect Oral Fluid Drug Screen Devices, Branan Medical Corporation (2012) Summary page 2.

## Most influential descendants
- K133047: Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls, Rapidease Oral Flu (2014), 0 descendants of its own

## Indications for use
The Salivabuse® liquid oral fluid controls are intended for in vitro diagnostic use only as quality controls to monitor the precision of laboratory oral fluid toxicology testing procedures for the analytes listed in the package insert. The Salivabuse® controls are available as multi-constituent and single constituent controls.

Source page: https://510kreport.com/device/K132688
Methodology: https://510kreport.com/methodology