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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 Description

The Salivabuse ® multi-constituent and the Salivabuse® single constituent controls are designed 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. Salivabuse® liquid oral fluid controls are available in Negative, Cutoff -60%, Cutoff -50%, Cutoff -30%, Cutoff -25%, Cutoff, Cutoff +2.5%. Cutoff +50%. 2X Cutoff and 3X Cutoff levels. Each bottle contains stabilized synthetic oral fluid. Positive controls have been gravimetrically spiked with authentic reference drug standards and/or appropriate metabolites. Negative controls are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain either sodium azide or a proprietary preservative compatible with products that are adversely affected by sodium azide.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study conducted for the Salivabuse® Liquid Oral Fluid Control, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Evaluation Parameter for Stability of Product Shelf Life (Temperature) (Open/Closed Vial)	Acceptance Criteria	Reported Device Performance
Refrigerated Temperature (2-8°C) (Open Bottle)	Positive controls test positive and Negative controls test negative. For value assignment, GC/MS analytes within ± 20% of target value at end of expiration date.	PASS: Data supports the 31-day open bottle stability claim at 2-8℃ for all analytes in the lots evaluated. All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative.
Refrigerated Temperature (2-8°C) (Closed Bottle)	Positive controls test positive and Negative controls test negative. For value assignment, GC/MS analytes within ± 20% of target value at end of expiration date.	PASS: All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative for 1 year for the drugs listed in submission (study ongoing).
Frozen Temperature (-10°C to -20°C) (Closed Vial)	Positive controls test positive and Negative controls test negative. For value assignment, GC/MS analytes within ± 20% of target value at end of expiration date.	PASS: All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative for 1 year for drugs listed in submission (studies ongoing).
Value Assignment (Immunoassay and Single-use devices)	Positive controls test positive and negative product tests negative.	PASS: All analytes tested met these acceptance criteria.
Value Assignment (GC/MS at end of expiration date)	Analytes were within ± 20% of target value.	PASS: All analytes met the acceptance criteria for the Salivabuse® controls.

2. Sample Size Used for the Test Set and Data Provenance

The text describes stability testing and value assignment for the Salivabuse® controls.

Stability Studies (Test Set):
- For each temperature condition (Refrigerated Open, Refrigerated Closed, Frozen Closed), 3 lots were tested.
- From each lot, 3 vials were tested.
- This means a minimum of 9 vials were used per temperature condition (3 lots * 3 vials).
- Data Provenance: The studies are described as "real time and accelerated stability testing" and "ongoing," suggesting a prospective nature. The manufacturer, Biochemical Diagnostics, Inc., is based in Edgewood, NY, USA, which implies the data provenance is likely from the USA, although specific geographic locations for testing labs are not explicitly stated beyond "Certified Independent laboratories."
Value Assignment (Test Set):
- An "initial production batch is sampled from the beginning, middle and end of production."
- "Single or multiple samples were analyzed." The exact number of samples is not specified.
- Data Provenance: Similar to stability, likely USA, from "Certified Independent laboratories using...SAMHSA licensed laboratories or CAP inspected and certified laboratories."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "experts" in the traditional sense (e.g., radiologists) is not applicable here. This device (Salivabuse®) is a quality control material, not a diagnostic imaging or interpretive device.

Ground truth for quality control materials is established through analytical methods and certified reference standards.
For value assignment and stability testing, the "ground truth" and verification of performance were established through:
- Certified Independent laboratories
- SAMHSA licensed laboratories or CAP inspected and certified laboratories
- These laboratories use established analytical techniques:
  - GC/MS (Gas Chromatography/Mass Spectrometry)
  - LC/MS (Liquid Chromatography/Mass Spectrometry)
  - Immunoassay analyzers
  - FDA cleared drugs of abuse screening devices
The qualifications of the personnel performing these analyses at these certified laboratories would align with standard laboratory practices for toxicology and clinical chemistry, but specific titles (e.g., "toxicologist with 10 years of experience") are not provided. The certification of the laboratories (SAMHSA, CAP) inherently implies qualified personnel and accredited procedures.

4. Adjudication Method for the Test Set

Adjudication, in the sense of resolving discrepancies between multiple human reviewers, is not applicable here. The "adjudication" for this type of device is inherent in the analytical methods and the acceptance criteria:

For Immunoassay and single-use devices, the outcome is binary: positive or negative.
For GC/MS and LC/MS, the outcome is quantitative, with acceptance criteria defined as being within a certain percentage of the target value.
The multiple lots and vials tested provide a form of internal validation, where consistent results across these samples confirm the stability and accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where accuracy depends on human interpretation (e.g., image-reading AI). The Salivabuse® control is an in vitro diagnostic quality control material, not a diagnostic device requiring human interpretation in its intended use.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This question is also not applicable in the context of this device. The Salivabuse® control is itself a "standalone" product (a liquid control material). Its performance is evaluated through its physical and chemical stability and its ability to elicit expected analytical results when run on various testing platforms (immunoassay, GC/MS, LC/MS). There is no "algorithm" to evaluate in isolation from human input.

7. The Type of Ground Truth Used

The ground truth for the Salivabuse® control material is established through:

Analytical Chemistry and Reference Standards:
- Gravimetric spiking with authentic reference drug standards and/or appropriate metabolites.
- Purity determination using analytical tools including GC/MS or NMR.
- Balances calibrated with weights traceable to National Institute of Standards and Technology (NIST).
- Certified negative by combination of immunoassay, GC/MS and/or LC/MS for negative controls.
- Confirmed by quantitative GC/MS and/or LC/MS performed by SAMHSA licensed or CAP inspected/certified laboratories.

This is a form of analytical ground truth derived from precise chemical preparation and validated analytical methods.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this device. Salivabuse® is a quality control material whose properties are precisely manufactured and then verified. It is not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device, this question is not applicable.

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