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The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

The Detectabuse® 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, at levels established by SAMHSA, CAP/AACC, many state programs and device manufacturers QC requirements. The Detectabuse® control urines are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents. They should be treated as any "unknown" specimen while following the specific protocol of the assay being used. This product is intended to be used under the supervision of health care professionals as an integral part of good laboratory practices.

Each bottle contains stabilized human based urine. Multi-constituent and single constituent positive control urines have been gravimetrically spiked with authentic reference drug standards and/or appropriate metabolites. Negative control urines are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain less than 1% sodium azide as a preservative. For assays sensitive to sodium azide such as ELISA we substitute a proprietary preservative approved by the manufacturers and DEA.

This document describes the performance characteristics and acceptance criteria for the Detectabuse® Liquid Control Urine device. This device is an In Vitro Diagnostic (IVD) intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures.

The study that proves the device meets the acceptance criteria is primarily an analytical performance study focusing on stability and traceability.

1. Table of Acceptance Criteria and Reported Device Performance

| Evaluation Parameter | Acceptance Criteria | Reported Device Performance |
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| Open Bottle Stability at 2-8°C | 31 days | Data support the 31-day open bottle stability at 2-8°C for all analytes. All analytes passed specifications, Positive controls tested positive, and Negative controls tested negative. |
| Closed Bottle Stability - Product Shelf Life (2-8°C) | Storage with Oxazepam expected to be negatively affected if >6 months. Other drugs within ±15% of target until expiration. | At 1 year, Oxazepam dropped 15-22%. At 3 years, Oxazepam dropped to 25%. Other drugs were within acceptable criteria of +/-15% from target until expiration date. Recommendation: Do not store Oxazepam-containing controls refrigerated for more than six months. |
| Closed Bottle Stability - Product Shelf Life (-10°C to -20°C) | Up to 4 years. Values within ±15% of target or original test value. | Multiple studies with various lots showed all drugs were stable within 15% of target or original test value between 3 and 4 years of frozen storage. |
| Room Temperature (open vial) Stability - Product Shelf Life (18°C to 21°C) | 31 days. Values within ±18% of target or original test value. | All drugs tested for 31 days were within 18% of target value or original test value. This supports stability during shipping or brief periods of customer error. |
| Value Assignment Criteria | Initially: ±5% agreement (acceptable to ±10% for certain difficult-to-test drugs). For Stat-Skreen® controls, positive controls must test positive and negative controls test negative. Final testing at shelf life: ±10% of target (acceptable to ±15% for certain stability-prone constituents like Oxazepam). | Initial production batch samples sent to 4-5 certified laboratories (at least 3 proficient for specific constituents). If a testing laboratory does not report within 10% of target, the sample is repeated. Once acceptable convergence of values is achieved, the lot is released. Stat-Skreen® controls are also tested on handheld devices against the criteria. Final testing at shelf life (GC/MS or LC/MS) aims for ±10% of target but accepts up to ±15% for specific constituents like Oxazepam. |

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

The document does not explicitly state a numerical sample size for "test sets" in the context of typical algorithm validation (i.e., a distinct set used for performance evaluation after training). Instead, the performance evaluations are described for stability studies and value assignment verification.

• Stability Studies: "Multiple bottles of a single lot" were pulled from beginning, middle, and end of production. "Several lots" of controls were selected for the room temperature study. "Multiple studies were conducted using various different lots."
• Value Assignment: "An initial production batch is sampled as described in the protocol and single or multiple samples (depending on our past experience with the constituent(s), are ordinarily sent out to 4 or 5 certified laboratories..."
• Data Provenance: The data is generated through laboratory testing of the control materials. The document implies a prospective data collection for stability studies (testing at initial, then at intervals) and for value assignment. The "certified independent laboratories" or "SAMHSA licensed laboratories or CAP inspected and certified" are likely located in the USA, given the FDA submission context.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth Establishment for Value Assignment: "Certified Independent laboratories" test by either GC/MS, LC/MS, or Immunoassay screening. For initial value assignment, "4 or 5 certified laboratories" (or at least 3 for less common constituents) perform testing. The qualifications for personnel performing these tests at "certified" or "SAMHSA licensed" or "CAP inspected and certified" labs are implied to be high, but specific expert qualifications (e.g., "radiologist with 10 years of experience") are not detailed. The expertise is in the analytical methods (GC/MS, LC/MS, immunoassay).

4. Adjudication Method

The adjudication method for value assignment resembles a form of consensus or agreement-based approach.

• "A minimum of 3 data points are collected for each assay."
• "Data collected from at least two test sites, testing performed within 1 week of receipt of test samples."
• "Our target acceptance criteria Is ±5% of the target value, but if we cannot get ± 5% agreement from our testing laboratories we will accept ± 10%... If a testing laboratory does not report within 10% of target we ask that the sample be repeated. Once we have an acceptable convergence of values from all of the testing laboratories the lot is released."

This suggests repeated testing and comparison among multiple labs with defined acceptance thresholds for agreement, rather than a formal 2+1 or 3+1 adjudication by individual experts in the traditional sense for image interpretation.

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

• No MRMC comparative effectiveness study was done. This device is a quality control material, not an AI diagnostic tool intended to assist human readers. Therefore, the concept of improving human reader performance with AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study

• A standalone performance study was done in the sense that the device, as a quality control material, is evaluated on its own analytical properties (stability, assigned values, precision monitoring capability) using laboratory instruments. There isn't an "algorithm" in the typical AI sense; the "device" itself is the control material. Its performance is measured by how precisely and accurately analytical instruments can detect the specified concentrations within the control.

7. Type of Ground Truth Used

The ground truth used for this device is based on analytical quantification methods and certified reference standards:

• Gravimetric spiking with authentic reference drug standards and/or appropriate metabolites.
• Purity determination using analytical tools including GC/MS, LC/MS, and NMR.
• Balances calibrated with weights traceable to National Institute of Standards and Technology (NIST).
• Testing by SAMHSA or CAP certified independent laboratories using GC/MS, LC/MS, or Immunoassay screening.
• Negative control urines are certified negative by combination of immunoassay, GC/MS and/or LC/MS.

This constitutes a highly rigorous, metrologically traceable analytical ground truth.

8. Sample Size for the Training Set

The concept of a "training set" as understood in machine learning is not applicable here. This device is a chemical control material, not an AI algorithm that learns from data. The manufacturing and validation processes involve:

• Reference standards and gravimetric preparation: These form the basis for the intended concentrations.
• Initial production batches: These are the manufacturing lots that undergo value assignment and stability testing as described above.

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

As noted above, there is no "training set" in the AI sense. The "ground truth" (i.e., the known and verified concentrations of analytes in the control material) is established through:

• Precise gravimetric preparation: Spiking authentic reference drug standards (traceable to NIST) into the human-based urine matrix at known concentrations.
• Purity verification of reference standards: Using advanced analytical techniques such as GC/MS, LC/MS, and NMR.
• Verification by multiple independent certified laboratories: The value assignment process, involving multiple labs and stringent acceptance criteria, serves to confirm the prepared concentrations with high confidence.

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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.

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.

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

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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