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The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOX Scan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOX Scan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. PROFILE®-V MEDTOXScan® Test Devices cannot be visually read.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings.

The PROFILE® V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations:

AMP Amphetamine (d-Amphetamine) 500 ng/mL
BAR Barbiturates (Butalbital) 200 ng/mL
BZO Benzodiazepines (Nordiazepam) 150 ng/mL
COC Cocaine (Benzoylecgonine) 150 ng/mL
MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL
MTD Methadone (Methadone) 200 ng/mL
OPI Opiates (Morphine) 100 ng/mL
OXY Oxycodone (Oxycodone) 100 ng/mL
PCP Phencyclidine (Phencyclidine) 25 ng/mL
PPX Propoxyphene (Norpropoxyphene) 300 ng/mL
THC Cannabinoids (11-nor-9-carboxy-Δ9-THC) 50 ng/mL
TCA Tricyclic Antidepressants (Desipramine) 300 ng/mL

Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed and previously cleared drug. Refer to specific product labeling for the combination of drug tests included on that test device.

THE PROFILE -V MEDTOXScan® DRUGS OF ABUSE TEST SYSTEM PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL . METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY / MASS SPECTROMETRY (GC/MS), HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) OR LIQUID CHROMATOGRAPHY / TANDEM MASS SPECTROMETRY (LC/MS/MS) ARE THE PREFERRED CONFIRMATORY METHODS. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.

The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan® Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination.

The PROFILE® V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The MEDTOXScan® Reader is an instrument used as an aid in determining the presence or absence of a colored line associated with the PROFILE®-V MEDTOXScan® one-step drugs of abuse qualitative screening immunoassays for the detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids) and Tricyclic Antidepressants or their metabolites. All analytes were previously cleared (K080635) except for the oxycodone, propoxyphene, and tricyclic anti-depressant analytes.

The MEDTOXScan® reader scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read, the analyte(s) associated with the device and whether the presence or absence of a line is associated with a negative or positive result. The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for PROFILE®V MEDTOXScan® Drugs of Abuse Test System

The primary acceptance criteria for the PROFILE®V MEDTOXScan® Drugs of Abuse Test System, as demonstrated in the clinical studies, revolve around its analytical agreement with GC/MS or LC/MS/MS methods for detecting drugs of abuse in urine samples.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" as a distinct section with specific numerical targets (e.g., "sensitivity must be >95%"). However, the clinical study results implicitly define the performance expected for substantial equivalence. The key performance metric is the percentage agreement with confirmed analytical methods (GC/MS or LC/MS/MS) across different concentration ranges.

The relevant performance metrics for the newly added analytes (Oxycodone, Propoxyphene, and Tricyclic Antidepressants) are derived from the clinical accuracy study (Table 5) and the sensitivity/precision study (Table 2).

Implicit Acceptance Criteria and Reported Device Performance (Focus on new analytes):

Summary of Discordant Results (Table 6):

• OXY (100 ng/mL): 1 false negative at 102 ng/mL (just above cutoff). The clinical study had 1 "near cutoff positive" sample (between cutoff and +50%) that tested negative.
• PPX (300 ng/mL): 4 false positives for samples between 182-271 ng/mL (all below cutoff). The clinical study had 4 "near cutoff negative" samples (between 50% and cutoff) that tested positive.
• TCA (300 ng/mL): 3 false positives for samples between 194-287 ng/mL (all below cutoff). The clinical study had 3 "near cutoff negative" samples (between 50% and cutoff) that tested positive.

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

• Clinical Test Set (Table 5):
  • Total samples: 125 (Negative) + 6 (Low negative) + 11 (Near Cutoff Negative) + 12 (Near Cutoff Positive) + 112 (High Positive) = 266 samples across all drugs (OXY, PPX, TCA).
  • For Oxycodone (OXY): 40 (No Drug) + 3 (Low Negative) + 4 (Near Cutoff Negative) + 3 (Near Cutoff Positive) + 36 (High Positive) = 86 samples.
  • For Propoxyphene (PPX): 45 (No Drug) + 1 (Low Negative) + 2 (Near Cutoff Negative) + 4 (Near Cutoff Positive) + 40 (High Positive) = 92 samples.
  • For Tricyclic Antidepressants (TCA): 40 (No Drug) + 2 (Low Negative) + 1 (Near Cutoff Negative) + 4 (Near Cutoff Positive) + 36 (High Positive) = 83 samples.
• Sensitivity/Precision Test Set (Table 2):
  • Each drug (OXY, PPX, TCA) was tested with 45 observations per concentration level.
  • There were 6 concentration levels for OXY and 5 for PPX and TCA, resulting in 270 observations for OXY and 225 observations for PPX and TCA each in this specific study.
• Data Provenance: The document states, "The samples were obtained from MEDTOX Laboratories." It doesn't specify the country of origin, but Medtox Diagnostics, Inc. is located in North Carolina, USA, suggesting the data is likely from the USA. The study is described as evaluating a "panel of blind coded clinical urine samples," which indicates it was a retrospective evaluation of existing samples, albeit with the device testing being prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The ground truth for the clinical test set was established by "GC/MS or LC/MS/MS results." These are instrumental analytical methods and do not typically involve human "experts" in the sense of physicians or clinical reviewers for direct interpretation of the primary result. The interpretation of these assays is based on established chemical analysis protocols.
• Therefore, the number of experts is not applicable in the traditional sense of clinical opinion, and their specific qualifications are not relevant here, as the comparison is against another laboratory-based analytical method.

4. Adjudication Method for the Test Set

• The ground truth was established by GC/MS or LC/MS/MS results. These are definitive chemical confirmatory methods. There is no mention of a human adjudication process (like 2+1, 3+1 consensus) for the ground truth itself, as the chemical analysis provides the "ground truth" concentrations. The device's results were then compared to these confirmed chemical values.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an automated reader for immunoassay test strips, and its output is a qualitative positive or negative result. The study involved comparison of the device's automated reading to reference chemical methods (GC/MS or LC/MS/MS), not a comparison of human readers' performance with and without AI assistance. The study explicitly states, "PROFILE®-V MEDTOXScan® Test Devices cannot be visually read."

6. Standalone Performance Study

• Yes, a standalone study was done. The entire clinical accuracy study and the sensitivity/precision study (Tables 2 & 5) describe the performance of the algorithm only (the device in its intended use, without human-in-the-loop decision making regarding the test line interpretation). The device "scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the type of device to be read... The results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed." Human operators run the test, but the interpretation is solely by the instrument's algorithm.

7. Type of Ground Truth Used

• The ground truth used was instrumental laboratory confirmatory methods: Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). This is a highly accurate and widely accepted method for confirming the presence and concentration of drugs and their metabolites in biological samples. The text refers to it as the "preferred confirmatory methods."

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set. The performance studies described are for validation of the device, implying that development and training (if a machine learning component were involved, though this is a rule-based algorithm) would have occurred prior to these studies. The existing analytes (Amphetamines, Barbiturates, etc.) were "previously cleared (K080635)," and "Performance studies have been conducted for the addition of Oxycodone, Propoxyphene, and Tricyclic Antidepressants through Medtox's internal Design Control process." This implies new studies for the added analytes, but no specific training set size is provided.

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

• Since the training set size and details are not provided, the method for establishing its ground truth is also not explicitly stated in this document. Given it's a diagnostic device for drugs of abuse, it's highly probable that ground truth for any training would also be established using gold-standard analytical methods like GC/MS or LC/MS/MS, similar to the validation set.

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