# K012907: Liquispx Liquid Saliva or Unrine Drug of Abuse Control

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Controls
- Decided: Sep 28, 2001 after 30 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.
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
Clinical Controls LiquiSPx™ Liquid Saliva/Urine Drugs of Abuse Control is a ready-to-use, assayed chemistry control materials for monitoring the accuracy and precision of saliva or urine drug assays. It is suitable for use with both manual and automated analytical procedures. Drug analysis consisting of measuring amphetamine, methamphetamine, phencyclidine, cocaine, tetrahydrocanabinol and morphine is used to assist in the detection and management of drug abuse in at risk patient populations.

Source page: https://510kreport.com/device/K012907
Methodology: https://510kreport.com/methodology