(67 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, 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, |
§ 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).