(90 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 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.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).