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The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:

This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.

Quidel Triage® MeterPro:

The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.

Quidel Triage® TOX Drug Screen, 94600:

The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.

Quidel Triage® MeterPro:

The Quidel Triage MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage MeterPro can be used in a laboratory or in a point-of-care setting.

The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.

The provided document describes the Quidel Triage® TOX Drug Screen, 94600 and the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine. The acceptance criteria and the study results are detailed in the "Performance Characteristics" section (1.13) and "Comparison studies" section (1.13.2.a).

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for each analyte are based on the percentage of positive and negative results at concentrations around the cutoff, as shown in the "Precision/Reproducibility" data in section 1.13.1.a and "Assay cut-off" in section 1.13.1.f. The primary performance metric from the method comparison study (1.13.2.a) is the agreement between the Quidel Triage TOX Drug Screen, 94600 and GC/MS or LC-MS/MS values, particularly for specimens near the threshold and outside the threshold.

Below is a summary table, combining data from the precision/reproducibility testing (1.13.1.a) and the method comparison study (1.13.2.a). For the precision/reproducibility, a high percentage of correct results (e.g., all negative below -75% of cutoff, all positive above +50% of cutoff) would be considered acceptance. For method comparison, "agreement" is implicitly the acceptance criteria, with discordant results requiring explanation.

• 126 ng/mL (-75%): 720/720 Neg (100%)
• 760 ng/mL (+50%): 720/720 Pos (100%)
• 522 ng/mL (Cutoff): 50 Neg/669 Pos (89.5% Pos) | Out of 220 samples:
• Negative (150% of threshold): 2 Neg/98 Pos (98% Pos)
  (Discordant results acknowledged and explained related to isomeric cross-reactivity.) |
  | mAMP (500 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 250 ng/mL (-50%): 720/720 Neg (100%)
• 742 ng/mL (+50%): 720/720 Pos (100%)
• 529 ng/mL (Cutoff): 281 Neg/431 Pos (60.0% Pos) | Out of 218 samples:
• Negative (150% of threshold): 7 Neg/91 Pos (92.9% Pos)
  (Discordant results acknowledged, with some attributed to isomeric differences in cross-reactivity.) |
  | BAR (200 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 53 ng/mL (-75%): 736/736 Neg (100%)
• 306 ng/mL (+50%): 719/719 Pos (100%)
• 192 ng/mL (Cutoff): 111 Neg/605 Pos (84.5% Pos) | Out of 218 samples:
• Negative (150% of threshold): 0 Neg/97 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | BZO (200 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 58 ng/mL (-75%): 704/704 Neg (100%)
• 306 ng/mL (+50%): 720/720 Pos (100%)
• 219 ng/mL (Cutoff): 318 Neg/402 Pos (55.9% Pos) | Out of 221 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | COC (150 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 76 ng/mL (-50%): 719/719 Neg (100%)
• 218 ng/mL (+50%): 736/736 Pos (100%)
• 157 ng/mL (Cutoff): 26 Neg/694 Pos (96.4% Pos) | Out of 220 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | EDDP (100 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 29 ng/mL (-75%): 720/720 Neg (100%)
• 143 ng/mL (+50%): 716/716 Pos (100%)
• 111 ng/mL (Cutoff): 126 Neg/594 Pos (82.5% Pos) | Out of 220 samples:
• Negative (150% of threshold): 0 Neg/98 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | OPI (300 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 165 ng/mL (-50%): 722/722 Neg (100%)
• 480 ng/mL (+50%): 720/720 Pos (100%)
• 344 ng/mL (Cutoff): 197 Neg/507 Pos (72.0% Pos) | Out of 220 samples:
• Negative (150% of threshold): 1 Neg/98 Pos (99.0% Pos)
  (Some discordant results explained by secondary reference testing.) |
  | THC (50 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 12 ng/mL (-75%): 716/716 Neg (100%)
• 78 ng/mL (+50%): 4 Neg/700 Pos (99.4% Pos)
• 54 ng/mL (Cutoff): 163 Neg/559 Pos (77.4% Pos) | Out of 221 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | TCA (1000 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 498 ng/mL (-50%): 719/719 Neg (100%)
• 1577 ng/mL (+50%): 1 Neg/719 Pos (99.9% Pos)
• 996 ng/mL (Cutoff): 218 Neg/518 Pos (70.4% Pos) | Out of 220 samples:
• Negative (150% of threshold): 1 Neg/95 Pos (99% Pos)
  (Some discordant results explained by data entry errors or pH interference.) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision/Reproducibility Test Set:
  • For each of the 9 analytes, 720-736 samples were tested for each concentration point (0 to +100% of cutoff, plus negative control). This means for each analyte, n=720-736 replicates were performed at each concentration.
  • Data provenance: Not explicitly stated, but the submission is for the FDA in the US. The study involved "three (3) study sites" which implies data collection within a controlled, prospective study setting, most likely in the US, given the FDA submission. The samples were "blinded and randomized" prior to testing.
• Method Comparison Test Set:
  • The total number of samples for each analyte in the method comparison study with GC/MS or LC-MS/MS varies slightly per analyte but is around 220 samples (e.g., for AMP, 99+11+2+98+0+0+8 = 218 specimens + 2 discordant cases).
  • Data provenance: The samples were described as "unaltered urine specimens," implying they were clinical samples. The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the use of "patient specimens" strongly suggests prospective collection for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For the Precision/Reproducibility study, the ground truth was established by the prepared concentrations of the analytes (e.g., negative control, 25%, 50%, 75%, cutoff, 125%, 150%, 175%, and 200% of cutoff). This does not involve human experts establishing ground truth for individual samples, but rather analytical controls.
• For the Method Comparison study, the ground truth was established by a "reference method," specifically GC/MS or LC-MS/MS values. These are analytical methods considered the gold standard for drug confirmation and quantification. This does not involve human experts establishing ground truth for each case, but rather the laboratory performing these reference methods. No specific number or qualifications of experts operating these reference instruments are mentioned, as the results of these instruments are considered the objective ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• For the Precision/Reproducibility study, no adjudication method is explicitly described as the results are based on measured values against known concentrations.
• For the Method Comparison study, particularly for discordant results between the device and the reference method, an adjudication process did occur. In some cases, explanations are provided for the discordance (e.g., isomeric cross-reactivity for AMP and mAMP, the presence of multiple metabolites for BZO and OPI, pH interference for TCA, or data entry errors). For OPI, one discordant case (Specimen ID 572644) was sent to a "second reference testing laboratory" for reconfirmation, which then aligned with the device's negative result. This indicates a form of secondary confirmation/adjudication by an additional reference lab for specific discordant cases, rather than a typical 2+1 or 3+1 expert consensus model for image/clinical interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This document describes an in vitro diagnostic (IVD) device that performs qualitative drug screening using a fluorescence immunoassay and a meter (Quidel Triage® MeterPro). It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or clinical data. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The Quidel Triage® TOX Drug Screen, 94600 with the Quidel Triage® MeterPro functions as a standalone device in terms of producing a "POS" or "NEG" result for each drug assay. The meter reads the test device and provides a direct qualitative result. While the meter requires a human operator to insert the device and, if desired, print or transmit results, the interpretation of the fluorescence signal into a positive or negative drug screen result is entirely performed by the instrument's programming, which is equivalent to an "algorithm only" performance. The performance data presented in the precision/reproducibility and method comparison studies directly reflect this standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the analytical performance studies (precision/reproducibility, analytical specificity, cutoff characterization), the ground truth was established by known prepared concentrations of drugs/metabolites or spiking experiments.
• For the method comparison study, the ground truth was established by Gas Chromatography / Mass Spectroscopy (GC/MS) or Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) values. These are analytical "gold standard" methods.

8. The sample size for the training set

• The document describes a 510(k) submission for a new IVD device and presents validation studies. It does not explicitly mention a "training set" in the context of machine learning or AI models. The studies are designed to demonstrate the analytical performance and substantial equivalence of the device to existing predicate devices. Therefore, a specific training set sample size is not applicable/not provided in this type of submission. The performance data is from a test/validation set.

9. How the ground truth for the training set was established

• As a "training set" is not explicitly referenced in the context of AI/machine learning development, the method of establishing its ground truth is not applicable/not provided. The ground truth for the validation studies (test sets) was established via known concentrations of analytes and reference methods (GC/MS, LC-MS/MS) as detailed above.

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