(344 days)
The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOXScan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine and THC (Cannabinoids) or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOXScan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. The 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
PCP Phencyclidine (Phencyclidine) 25 ng/mL
THC Cannabinoids (11-nor-9-carboxy-C9-THC) 50 ng/mL
Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed drug analytes.
THE PROFILE®-V MEDTOXScan® Drugs of Abuse Test System provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. 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 OC 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 remaved 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 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: Amphetamine, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates. Barbiturates, Phencyclidine, and THC (Cannabinoids) or their metabolites.
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. The PROFILE® V MEDTOXScan® Test Devices cannot be visually read.
Here's a breakdown of the acceptance criteria and the study details for the PROFILE® V MEDTOXScan® Drugs of Abuse Test System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to its ability to accurately detect the presence or absence of specific drugs of abuse at defined cutoff concentrations. The performance is reported as the percentage agreement with GC/MS or LC/MS/MS results for clinical urine samples.
| Drug / Analyte (Cutoff) | Acceptance Criteria (Implicit) | Reported Device Performance (% Agreement) | Notes |
|---|---|---|---|
| AMP Amphetamine (500 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 96% | |
| Negative: 92% | Some discordance near cutoff. | ||
| BAR Barbiturates (200 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 94% | Some discordance near cutoff. | ||
| BZO Benzodiazepines (150 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 98% | Some discordance near cutoff. | ||
| COC Cocaine (150 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 97% | |
| Negative: 97% | Some discordance near cutoff. | ||
| MAMP Methamphetamine (500 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 98% | |
| Negative: 98% | Some discordance near cutoff. | ||
| MTD Methadone (200 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 98% | |
| Negative: 96% | Some discordance near cutoff. | ||
| OPI Opiates (100 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 94% | Some discordance near cutoff. | ||
| PCP Phencyclidine (25 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 93% | Some discordance near cutoff. | ||
| THC Cannabinoids (50 ng/mL) | High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations. | Positive: 100% | |
| Negative: 96% | Some discordance near cutoff. | ||
| All Drugs Combined | Overall high agreement with GC/MS or LC/MS/MS. | Positive: 98.5% | |
| Negative: 95.3% |
2. Sample Size Used for the Test Set and Data Provenance
The "Clinical Tests" section describes the evaluation of a "panel of blind coded clinical urine samples." The sample sizes for each drug are:
- AMP: 40 negative, 5 low negative, 0 near cutoff negative, 4 positive (between -50% and cutoff), 5 positive (between cutoff and +50%), 41 high positive = 95 samples
- BAR: 40 negative, 3 low negative, 2 near cutoff negative, 3 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 36 high positive = 88 samples
- BZO: 40 negative, 3 low negative, 3 near cutoff negative, 1 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 41 high positive = 92 samples
- COC: 56 negative, 1 low negative, 5 near cutoff negative, 2 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 52 high positive = 120 samples
- mAMP: 40 negative, 4 low negative, 3 near cutoff negative, 1 positive (between -50% and cutoff), 3 positive (between cutoff and +50%), 40 high positive = 91 samples
- MTD: 40 negative, 4 low negative, 2 near cutoff negative, 2 positive (between -50% and cutoff), 3 positive (between cutoff and +50%), 40 high positive = 91 samples
- OPI: 46 negative, 2 low negative, 3 near cutoff negative, 3 positive (between -50% and cutoff), 5 positive (between cutoff and +50%), 44 high positive = 103 samples
- PCP: 40 negative, 0 low negative, 1 near cutoff negative, 0 positive (between -50% and cutoff), 2 positive (between cutoff and +50%), 20 high positive = 63 samples
- THC: 40 negative, 0 low negative, 4 near cutoff negative, 0 positive (between -50% and cutoff), 7 positive (between cutoff and +50%), 30 high positive = 81 samples
Data Provenance: The samples were obtained from MEDTOX Laboratories. The study is retrospective, as it uses a "panel of blind coded clinical urine samples" which implies pre-collected samples. The country of origin is not explicitly stated, but MEDTOX Diagnostics, Inc. is located in North Carolina, USA, and MEDTOX Laboratories is a US-based company, suggesting the data is likely from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the clinical test set was established using Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). These are analytical laboratory methods, not human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" does not directly apply to the primary ground truth determination in this study. The "in-house operators" who performed the testing using the device would be trained laboratory personnel, but their role was to operate the device and not to establish the ground truth.
4. Adjudication Method for the Test Set
No explicit adjudication method (like 2+1 or 3+1 consensus with human readers) is mentioned. The ground truth was established by GC/MS or LC/MS/MS, which are considered definitive analytical methods for drug detection and quantification. Discordant results (where the device result didn't match the GC/MS/LC/MS/MS result) are detailed in Table 5, but there's no mention of an adjudication process by human experts for these cases beyond the initial GC/MS or LC/MS/MS determination.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an automated reader for an immunoassay, not an AI system designed to assist human readers in image interpretation or diagnosis. The study assessed the device's performance against a gold standard (GC/MS/LC/MS/MS), not its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance study was conducted. The PROFILE® V MEDTOXScan® Reader is an automated instrument that interprets the results of the immunochromatographic test devices. The study evaluates the performance of this automated system in interpreting results without human intervention in the interpretation step. The "in-house operators" perform the technical steps of running the test devices and operating the reader, but the result interpretation is done by the reader's software algorithms.
7. The Type of Ground Truth Used
The primary ground truth used for the clinical test set was analytical confirmation by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). These are considered the gold standard methods for drug detection and quantification in urine.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for a training set. The studies described are primarily performance evaluation studies (e.g., around cutoff, cross-reactivity, interference, and clinical accuracy). While the device uses "software algorithms," there's no information provided about a specific "training set" used to develop or refine these algorithms. The device likely relies on predefined logic and calibration rather than a machine learning model trained on a large dataset in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" with ground truth establishment for algorithm learning is not mentioned in the document, this information is not provided. The device's operation is based on reading relative line intensities using a contact imaging sensor and applying software algorithms, implying fixed logic and potentially factory calibration rather than a learned model from a training set. The "Sensitivity/Precision/Distribution of Random Error" study (Table 2) uses standard drug solutions at various concentrations, which would be known values, and could be considered part of the development and characterization of the device's reading capabilities, analogous to establishing parameters rather than training a machine learning model.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).