SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
Device Facts
| Record ID | K132688 |
|---|---|
| Device Name | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ |
| Applicant | Biochemical Diagnostics, Inc. |
| Product Code | DIF · Clinical Toxicology |
| Decision Date | Dec 16, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
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.
Device Story
Salivabuse® liquid oral fluid controls consist of stabilized synthetic oral fluid spiked with authentic reference drug standards or metabolites. Available in various concentrations (Negative, Cutoff, 2X, 3X, etc.) for multi-constituent or single-constituent testing. Used in clinical laboratories to monitor precision and accuracy of toxicology screening procedures for amphetamines, methamphetamines, cocaine, benzoylecgonine, opiates, PCP, cannabinoids, barbiturates, benzodiazepines, methadone, cotinine, and ethanol. Laboratory personnel use these controls to verify performance of immunoassay analyzers or screening devices. By comparing control results against expected values, clinicians identify reagent or instrument defects, ensuring reliability of patient toxicology test results.
Clinical Evidence
Bench testing only. Stability studies (real-time and accelerated) confirmed 31-day open-vial stability at 2-8°C and 1-year closed-vial stability at 2-8°C and -10°C to -20°C. Value assignment performed via GC/MS, LC/MS, and FDA-cleared immunoassay screening devices. Acceptance criteria required positive controls to test positive and negative controls to test negative, with GC/MS values within ±20% of target.
Technological Characteristics
Stabilized synthetic oral fluid matrix; contains sodium azide or proprietary preservative. Available as multi-constituent or single-constituent liquid. Storage: -10°C to -20°C (frozen) or 2-8°C (refrigerated). Analytical verification via GC/MS, LC/MS, and immunoassay. No electronic components or software.
Indications for Use
Indicated for use as quality control material in laboratory oral fluid toxicology testing procedures to monitor precision and detect systematic deviations. Intended for professional use in clinical laboratory settings.
Regulatory Classification
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
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