← Product Code [DIF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF) · K132688

# SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ (K132688)

_Biochemical Diagnostics, Inc. · DIF · Dec 16, 2013 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K132688

## Device Facts

- **Applicant:** Biochemical Diagnostics, Inc.
- **Product Code:** [DIF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF.md)
- **Decision Date:** Dec 16, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3280
- **Device Class:** Class 1
- **Review Panel:** Clinical Toxicology

## 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.

## Regulatory 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.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k132688

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K132688](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K132688)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com