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510(k) Data Aggregation
(90 days)
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
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, Buprenorphine, Cocaine, 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
BUP Buprenorphine (Buprenorphine) 10 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 or 2000 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-r9-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. Test Devices will have an opiate cutoff of either 100 ng/mL or 2000 ng/mL. 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 MEDTOXScar® Test Devices and the MEDTOXScam® Reader. The MEDTOX Scan® Reader is an instrument used as an aid in determining the presence of a colored line associated with the PROFILE®-V MEDIOXScan® one-step drugs of abuse qualitative screening immunoassays for the detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazenines, Buprenorphine, Cocaine, Methamphetamine, Opiates, Oxycodone, Phencyclidine. Propoxyphene, THC (Cannabinoids) and Tricyclic Antidepressants or their metabolites. All analytes were previously cleared for the test system (K091454) except for the buprenorphine and opiates with the 2.000 ng/mL cutoff (OPI 2k). OPI 2K was previously cleared for visual use (K992111).
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.
Acceptance Criteria and Device Performance Study for PROFILE®-V MEDTOXScan® Drugs of Abuse Test System
This document outlines the acceptance criteria and details the studies conducted to demonstrate the substantial equivalence of the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System.
1. Table of Acceptance Criteria and Reported Device Performance
The device is intended for the rapid, qualitative detection of drugs of abuse in human urine. The acceptance criteria for performance are derived from the analytical and clinical studies demonstrating agreement with GC/MS or LC/MS/MS reference methods, particularly around the drug cutoff concentrations.
| Drug / Specific Drug Cutoff Concentration | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance (Agreement with Confirmatory Methods) |
|---|---|---|
| Buprenorphine (10 ng/mL) | Ability to distinguish negative, near cutoff negative, near cutoff positive, and high positive samples with high accuracy. | Positive: 100% agreement for Near Cutoff Positive (4/4) and High Positive (36/36) samples. |
| Negative: 100% agreement for No Drug (40/40) and Near Cutoff Negative (4/4) samples. | ||
| Opiates (2,000 ng/mL) | Ability to distinguish negative, near cutoff negative, near cutoff positive, and high positive samples with high accuracy. | Positive: 100% agreement for Near Cutoff Positive (4/4) and High Positive (36/36) samples. |
| Negative: 98% agreement for No Drug (40/40), Low Negative (4/4), and Near Cutoff Negative (3/4) samples. (One discordant result: OPI positive at 1,375 ng/mL Morphine, below 2,000 ng/mL cutoff) | ||
| Overall Accuracy (Buprenorphine & Opiates combined) | High overall agreement with confirmatory methods. | Positive: 100% agreement (72+8/80 = 80/80). |
| Negative: 99% agreement (80+4+7/91 = 91/91 for negative results). | ||
| Sensitivity/Precision/Distribution of Random Error (Opiates 2,000 ng/mL) | Expected positive rates at and above cutoff, and negative rates below cutoff. | 0 ng/mL: 45/45 Negative (100%) |
| 1,000 ng/mL (50%): 45/45 Negative (100%) | ||
| 1,500 ng/mL (75%): 31/45 Negative, 14/45 Positive (31% Positive) | ||
| 2,500 ng/mL (125%): 45/45 Positive (100%) | ||
| 3,000 ng/mL (150%): 45/45 Positive (100%) | ||
| Sensitivity/Precision/Distribution of Random Error (Buprenorphine 10 ng/mL) | Expected positive rates at and above cutoff, and negative rates below cutoff. | 0 ng/mL: 45/45 Negative (100%) |
| 5.0 ng/mL (50%): 45/45 Negative (100%) | ||
| 7.5 ng/mL (75%): 30/45 Negative, 15/45 Positive (33% Positive) | ||
| 12.5 ng/mL (125%): 45/45 Positive (100%) | ||
| 15.0 ng/mL (150%): 45/45 Positive (100%) | ||
| Cross-Reactivity (Buprenorphine) | Limited or no cross-reactivity with specified related compounds. | Buprenorphine-glucuronide (50%), Norbuprenorphine (4%), Norbuprenorphine-glucuronide (2%) showed cross-reactivity. Other listed compounds (e.g., Codeine, Morphine) showed None Detected cross-reactivity at 100,000 ng/mL. |
| Cross-Reactivity (Opiates 2,000 ng/mL) | Expected cross-reactivity with opiate-related compounds, limited or no with non-opiates. | Codeine (222%), Diacetylmorphine (80%), Dihydrocodeine (53%), Ethylmorphine (333%), Hydrocodone (143%), Hydromorphone (105%), Levorphanol (40%), 6-Monoacetylmorphine (53%), Morphine 3-β-D-Glucuronide (40%), Morphine 6-β-D-Glucuronide (33%), Norcodeine (5%), Thebaine (80%) showed cross-reactivity. Other listed compounds (e.g., Apomorphine, Naloxone) showed None Detected cross-reactivity at 100,000 ng/mL. |
| Interference (pH, Specific Gravity, Common Drugs) | No interference (affecting expected results) from varying pH, specific gravity, and common drugs. | All pH samples (4.0, 7.0, 9.0 ± 0.1) and specific gravity samples (1.003, 1.015, 1.030 ± 0.001) gave expected negative and positive results when fortified. None of the listed common drugs (e.g., Acetylsalicylic Acid, Acetaminophen) affected the expected results. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set:
- Buprenorphine (BUP 10 ng/mL): 40 Negative samples (No Drug) + 4 Near Cutoff Negative samples + 4 Near Cutoff Positive samples + 36 High Positive samples = 84 samples
- Opiates (OPI 2,000 ng/mL): 40 Negative samples (No Drug) + 4 Low Negative samples + 3 Near Cutoff Negative samples + 4 Near Cutoff Positive samples + 36 High Positive samples = 87 samples
- Overall for Both Drugs: 171 samples (80 Negative, 4 Low Negative, 7 Near Cutoff Negative, 8 Near Cutoff Positive, 72 High Positive).
- Sensitivity/Precision/Distribution of Random Error Test Set:
- For each drug (Opiates 2,000 ng/mL and Buprenorphine 10 ng/mL), 5 different concentrations were tested. Each concentration was tested in triplicate on 5 different intervals, resulting in 45 observations per concentration.
- Total observations for this study: 5 concentrations * 45 observations/concentration * 2 drugs = 450 observations.
- Data Provenance:
- The clinical urine samples were obtained from MEDTOX Laboratories.
- The data is retrospective, as it refers to "clinical urine samples containing varying concentrations of drugs" that were "obtained from MEDTOX Laboratories" and subsequently "assayed" and "compared to GC/MS or LC/MS/MS results." The description implies these were pre-existing samples.
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 by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS), which are instrumental analytical methods, not human expert interpretation.
For the sensitivity/precision study and cross-reactivity/interference studies, standard drug solutions were diluted in drug-free urine or reference standards were prepared in negative urine samples. The precise concentration was confirmed by GC/MS or LC/MS/MS methods. Therefore, the ground truth was also established via these analytical methods.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or applicable, as the ground truth was established by objective instrumental methods (GC/MS or LC/MS/MS) rather than subjective human interpretation. The MEDTOXScan® Reader automatically interpreted results at ten minutes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device, the PROFILE®-V MEDTOXScan® Reader, is an instrument that interprets and reports results. It replaces visual reading by humans, and thus, a study comparing human readers with and without AI assistance is not applicable in the traditional sense. The device automates the reading process.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The "PROFILE®-V MEDTOXScan® Drugs of Abuse Test System" essentially operates as a standalone algorithm/instrument. The device includes the MEDTOXScan® Reader which utilizes "software algorithms" to identify the device, analyte, and interpret the presence or absence of a line to determine positive or negative results. The results are "displayed on the MEDTOXScan® screen or optionally can be printed." The description explicitly states: "PROFILE®-V MEDTOXScan® Test Devices cannot be visually read," meaning the device's performance is entirely dependent on its automated reading capability.
7. Type of Ground Truth Used
The type of ground truth used was Instrumental Confirmatory Methods (GC/MS or LC/MS/MS). For the clinical studies, "Drug concentrations were assayed by GC/MS or LC/MS/MS." These are considered the gold standard for drug confirmation. For the analytical studies (sensitivity, precision, cross-reactivity), drug solutions or reference standards were prepared, and their concentrations were confirmed by these methods.
8. Sample Size for the Training Set
The document does not specify the sample size for a training set. The studies described are performance validation studies for the device itself, comparing its output to confirmatory methods. It's implied that the software algorithms for the MEDTOXScan® Reader were developed and possibly internally validated prior to these submission studies. However, details regarding the training data for the internal algorithms are not provided in this 510(k) summary.
9. How the Ground Truth for the Training Set was Established
As the document does not specify a training set or its sample size, it also does not describe how the ground truth for any potential training set was established. While the clinical and analytical validation studies use GC/MS or LC/MS/MS as ground truth, information regarding the ground truth establishment for the development or training of the device's internal algorithms (e.g., line detection, interpretation logic) is not disclosed in this summary.
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(67 days)
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
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):
| Metric / Analytes (Cutoff) | Implicit Acceptance Standard (Desired Performance based on context) | Reported Device Performance (Clinical Accuracy, Table 5) | Reported Device Performance (Sensitivity/Precision, Table 2) |
|---|---|---|---|
| Overall Agreement (Positive) | High agreement with confirmatory methods for samples at or above the cutoff. | OXY (100 ng/mL): 98% (3 positives in near cutoff positive, 36 in high positive matched positive) | Not directly applicable; this table focuses on detection rates at specific concentrations relative to cutoff. Values like "0" negatives at 125% and 150% of cutoff, and "45" positives at these levels, indicate high sensitivity above the cutoff. |
| Overall Agreement (Negative) | High agreement with confirmatory methods for samples below the cutoff. | OXY (100 ng/mL): 100% (40 no-drug negatives, 3 low negative, 4 near cutoff negative matched negative). | Not directly applicable; "45" negatives at 0 ng/mL and 25% of cutoff indicate high specificity below these levels. |
| PPX (300 ng/mL): 100% (4 positives in near cutoff positive, 40 in high positive matched positive) | PPX (300 ng/mL): 92% (45 no-drug negatives, 1 low negative, 2 near cutoff negative matched negative). Note: There are 4 "near cutoff negative" samples that tested "Positive" by the device, and 2 "near cutoff positive" samples that tested "Negative" by the device (Table 6 clarifies the latter as 2 false negatives above cutoff). | ||
| TCA (300 ng/mL): 100% (4 positives in near cutoff positive, 36 in high positive matched positive) | TCA (300 ng/mL): 93% (40 no-drug negatives, 2 low negative, 1 near cutoff negative matched negative). | ||
| Performance near Cutoff (Sensitivity) | Demonstrate high positive detection rate for samples at or above the cutoff concentration (e.g., >80% at 75% cutoff, 100% at 125% cutoff). | For Oxycodone, Propoxyphene, and TCA, all "High Positive (greater than +50%)" samples (total 112) were correctly identified as positive. | OXY (100 ng/mL): 75% cutoff (26/45 Pos), 125% cutoff (45/45 Pos), 150% cutoff (45/45 Pos) |
| Performance near Cutoff (Specificity) | Demonstrate high negative detection rate for samples below the cutoff concentration (e.g., 100% at 0 ng/mL, |
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(344 days)
MEDTOXSCAN
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.
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