(344 days)
Not Found.
No
The description mentions "Software algorithms" for interpreting line intensities, but there is no mention of AI, ML, or any learning-based approach. The interpretation appears to be based on predefined thresholds or rules applied to the captured image data.
No
This device is for in vitro diagnostic use, intended for the rapid, qualitative detection of drugs or their metabolites in human urine. It is not used for treating or preventing disease.
Yes.
The "Intended Use / Indications for Use" section explicitly states: "The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use..."
No
The device description explicitly states that the system consists of both "PROFILE® V MEDTOXScan® Test Devices" and the "MEDTOXScan® Reader," which is described as an "instrument" that uses a "contact imaging sensor (CIS)" to capture data from the test devices. This indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use..."
- Nature of the Test: The device is designed to detect the presence of drugs or their metabolites in human urine, which is a biological sample. This is a characteristic of in vitro diagnostic tests.
- Purpose: The test is used to provide a preliminary analytical result for the detection of drugs of abuse, which is a diagnostic purpose.
- Professional Use: The device is intended for professional use, typically in a laboratory setting, which is common for IVDs.
Therefore, based on the provided text, the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JJQ, DKZ, DIS, JXM, DIO, DJR, DJC, DJG, LCM, LDJ
Device Description
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.
Mentions image processing
Yes, "Utilizes a contact imaging sensor (CIS) to capture relative line intensities."
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Contact imaging sensor (CIS)
Anatomical Site
Not Found.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Professional use only. Not intended for use in point-of-care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
A panel of blind coded clinical urine samples containing varying concentrations of drugs were assayed.
The samples were obtained from MEDTOX Laboratories and grouped in the following manner:
- Negative samples that screened negative by KIMS (Kinetic Interaction of Microparticles in Solution), and not confirmed by GC/MS
- Below Cutoff Negative samples that fell between limit of detection or quantitation and 50% of cutoff
- Near Cutoff Negative samples that fell between 50% of the cutoff concentration and the cutoff concentration
- Near Cutoff Positive samples that fell between the cutoff concentration and 150% of the cutoff concentration
- High Positive samples that were greater than 150% of cutoff concentrations
GC/MS or LC/MS/MS was used for BZO. Concentrations used to assign the cutoff ranges for each drug were determined by summing the GC/MS and LC/MS/MS levels measured for all test-specific analytes found in the sample. The testing was performed by in-house operators. The results were interpreted at ten (10) minutes by the MEDTOXScan® reader.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
Numerous laboratory performance studies were conducted to determine the substantial equivalence of the MEDTOXScan® test to the Triage Meter.
1. Sensitivity/Precision/ Distribution of Random Error:
- Study Type: Performance around specific cutoff for each drug.
- Sample Size: 45 determinations for each drug concentration level (standard drug solutions diluted in drug-free urine).
- Protocol: Standard drug solutions diluted in drug-free urine were tested in triplicate on 5 different intervals by 3 in-house operators using different readers. Drug free urine was also tested on each interval. Results were interpreted at ten minutes by the MEDTOXScan® Reader.
- Key Results: The table shows the number of negative and positive observations at various concentrations (0, 20%, 50%, 75%, 125%, 150% of cutoff) for Amphetamine (500 ng/mL), Barbiturates (200 ng/mL), Benzodiazepines (150 ng/mL), Cocaine (150 ng/mL), Methamphetamine (500 ng/mL), Methadone (200 ng/mL), Opiates (100 ng/mL), Phencyclidine (25 ng/mL), and THC (50 ng/mL).
2. Other Technical Performance Documentation:
- Influence of Temperature
- Influence of Humidity
- Factory Calibration
- Electrical and EMC Testing
- Validation and stability of QC Control Cassette
- Validation and stability of Cleaning Cassette
3. Analytical specificity (cross reactivity and interference):
- Related Compounds and Cross Reactants: Evaluated various metabolites and reacting compounds by preparing reference standards in negative urine samples. Results expressed as minimum concentration required to produce a positive result.
- Interference Data - pH and Specific Gravity: Tested with three negative clinical samples at pH 4.0, 7.0, and 9.0 ± 0.1, and specific gravity 1.003, 1.015, and 1.030 ± 0.001. Samples were fortified to give strong negative (95% or greater negative) and strong positive (95% or greater positive) results. All pH and specific gravity samples gave expected results.
- Common Drugs: Drug-free urine samples were spiked to give strong negative and strong positive results, then 100,000 ng/mL of common drugs were added and assayed. None of the listed common drugs affected the expected results.
Discussion of Clinical Tests Performed for Determination of Substantial Equivalence:
- Study Type: Accuracy evaluation using blind coded clinical urine samples.
- Key Results:
- No false positives observed in the absence of drug.
- Percent agreements with GC/MS or LC/MS/MS values were reported for each drug:
- AMP (500): 96% positive agreement, 92% negative agreement.
- BAR (200): 100% positive agreement, 94% negative agreement.
- BZO (150): 100% positive agreement, 98% negative agreement.
- COC (150): 97% positive agreement, 97% negative agreement.
- mAMP (500): 98% positive agreement, 98% negative agreement.
- MTD (200): 98% positive agreement, 96% negative agreement.
- OPI (100): 100% positive agreement, 94% negative agreement.
- PCP (25): 100% positive agreement, 93% negative agreement.
- THC (50): 100% positive agreement, 96% negative agreement.
- All Drugs: 98.5% positive agreement, 95.3% negative agreement.
- Detailed discordant results (P-V MEDTOXScan Test System result vs. GC/MS or LC/MS/MS value) were provided for samples with preliminary positive results below the cutoff and negative results above the cutoff.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity/Precision/ Distribution of Random Error: Number of negative and positive observations measured at various percentages of the cutoff concentration (e.g., for AMP, at 50% cutoff, 41 negative, 4 positive; at 125% cutoff, 8 negative, 37 positive).
- Analytical Specificity: % Cross-Reactive values for various related compounds and cross-reactants for each drug class.
- Clinical Accuracy:
- % Agreement:
- AMP (500): 96% Positive agreement, 92% Negative agreement
- BAR (200): 100% Positive agreement, 94% Negative agreement
- BZO (150): 100% Positive agreement, 98% Negative agreement
- COC (150): 97% Positive agreement, 97% Negative agreement
- mAMP (500): 98% Positive agreement, 98% Negative agreement
- MTD (200): 98% Positive agreement, 96% Negative agreement
- OPI (100): 100% Positive agreement, 94% Negative agreement
- PCP (25): 100% Positive agreement, 93% Negative agreement
- THC (50): 100% Positive agreement, 96% Negative agreement
- All Drugs: 98.5% Positive agreement, 95.3% Negative agreement
- % Agreement:
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Triage Meter (K973547)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found.
§ 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).
0
Koso63s
FEB 1 3 2009
:
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: K080635.
| Submitted By: | Medtox Diagnostics, Inc.
1238 Anthony Road
Burlington, North Carolina 27215 |
| --------------- | ----------------------------------------------------------------------------------- |
|---|
Contact Person: Phillip Hartzog, Ph.D. Director, Research & Development 336-226-6311. ext. 2863 Phone: Fax: 336-229-4471
Date Prepared: February 10, 2009
PROFILE - V MEDTOXScan® Drugs of Abuse Test System Proprietary Name:
Common Name: Colorimeter, Drugs of Abuse Test System
Classification Names:
The applicant test system regulatory classification is Classification Panel is Clinical Toxicology (91) and Clinical Chemistry (75). Regulatory information applicable to the test system is provided below:
| CFR Section | Product Code |
|---|---|
| 862.2300, Colorimeter, Photometer, Spectrophotometer for Clinical Use | JJQ |
| 862.3100, Amphetamine Test System | DKZ |
| 862.3150, Barbiturate Test System | DIS |
| 862.3170, Benzodiazepine Test System | JXM |
| 862.3250, Cocaine and cocaine metabolite Test System | DIO |
| 862.3620, Methadone Test System | DJR |
| 862.3610, Methamphetamine Test System | DJC |
| 862.3650, Opiate Test System | DJG |
| 862.3100, Amphetamine Test System (Phencyclidine) | LCM |
| 862.3870, Cannabinoid Test System | LDJ |
Triage® Meter (K973547) Predicate Device:
Description of the Device
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
1
displayed on the MEDTOXScan® screen or optionally can be printed. The PROFILE® V MEDTOXScan® Test Devices cannot be visually read.
Intended Use
The PROFILE V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. I The PROFILE® V MEDTOXScan® Test Devices are one-step immunochromatographic tests for the rapid, Amphetamine. qualitative detection of one or more of the following in human urine: 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-Δ9-THC) | 50 ng/mL |
Configurations of the PROFILE V MEDTOXScan® Test Devices may consist of any combination of the above listed drug analytes. 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 (see "Troubleshooting" Section).
2
Discussion of Technological Characteristics:
Similarities and differences to predicate device a.
Both the applicant and the predicate test systems are used to detect the presence of drugs of abuse and their metabolites in human urine. In both systems, a urine sample is added to the test device and allowed to react for a specified period of time, after which an instrument is used to read the test device and interpret and display the test result. Both the applicant and predicate test devices are rapid single use disposable devices that use immunochromatographic lateral flow technology. The applicant test device utilizes gold-conjugated reagents to generate the reddish-purple test and controls lines, which are read by the instrument. The predicate test device uses fluorescent-conjugated reagents to generate control and test lines that are not visible and can be read only by the instrument.
Overall performance and characteristics of the MEDTOXScan® and the predicate device, the Triage Meter, are summarized in Table 1 below:
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | Determines qualitative positive or negative result from drug of abuse | |
| immunoassay screens. | Determines qualitative positive or negative result from drug of abuse | |
| immunoassay screens. | ||
| System | ||
| Procedure | Sample is added to a single use test cassette, which is then read by | |
| instrument. Instrument is designed to read multiple single use test | ||
| cassettes, one at a time. | Sample is added to a single use test cassette, which is then read by | |
| instrument. Instrument is designed to read multiple single use test | ||
| cassettes, one at a time. | ||
| Measurement | ||
| Method | Scans the single-use test cassette to detect a signal. | Scans the single-use test cassette to detect a signal. |
| Output | Outputs "positive," "negative," and | |
| "invalid" test results on paper | ||
| printout or LCD screen. | Outputs "positive, "and "negative," | |
| test results on paper printout. |
| Differences | ||
|---|---|---|
| Item | Device | Predicate |
| Single-Use | ||
| Test Cassette | Produces colored lines on device. | Produces a fluorescent signal that is |
| not visible to the instrument operator. | ||
| Assay Type | Competitive assay where | |
| concentration of drug is inversely | ||
| related to the visible signal | ||
| detected by the instrument. | Competitive assay where | |
| concentration of drug is inversely | ||
| related to the fluorescent signal | ||
| detected by the instrument. | ||
| Detection | ||
| Method | Measures reflectance of visible | |
| lines on single use test cassette. | Measures fluorescent signal on single | |
| use test cassette. |
Table 1. Comparison of Similarities and Differences for the MEDTOXScan reader and predicate device.
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
Numerous laboratory performance studies were conducted to determine the substantial equivalence of the MEDTOXScan® test to the Triage Meter. These studies are as follows:
3
- Performance of the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System around the . specific cutoff for each drug was evaluated by testing standard drug solutions diluted in drug-free urine in triplicate on 5 different intervals by 3 in-house operators using different readers (45 determinations for each level). Drug free urine was also tested on each interval. The results were interpreted at ten minutes by the MEDTOXScan® Reader and are summarized for each drug in Table 2 below:
| Sample
Concentration
(ng/mL) | % of
Cutoff | Number of
Observations | #
Neg | #
Pos | Sample
Concentration
(ng/mL) | % of
Cutoff | Number of
Observations | # Neg | # Pos |
|------------------------------------|----------------|---------------------------|----------|----------|------------------------------------|----------------|---------------------------|-------|-------|
| AMP (500) | | | | | BAR (200) | | | | |
| 0 | NEG | 45 | 45 | 0 | 0 | NEG | 45 | 45 | 0 |
| 100 | 20% | 45 | 45 | 0 | 100 | 50% | 45 | 45 | 0 |
| 250 | 50% | 45 | 41 | 4 | 150 | 75% | 45 | 32 | 13 |
| 375 | 75% | 45 | 37 | 8 | 250 | 125% | 45 | 0 | 45 |
| 625 | 125% | 45 | 8 | 37 | 300 | 150% | 45 | 0 | 45 |
| 750 | 150% | 45 | 0 | 45 | | | | | |
| BZO (150) | | | | | COC (150) | | | | |
| 0 | NEG | 45 | 45 | 0 | 0 | NEG | 45 | 45 | 0 |
| 75 | 50% | 45 | 45 | 0 | 75 | 50% | 45 | 45 | 0 |
| 112.5 | 75% | 45 | 33 | 12 | 112.5 | 75% | 45 | 24 | 21 |
| 187.5 | 125% | 45 | 8 | 37 | 187.5 | 125% | 45 | 0 | 45 |
| 225 | 150% | 45 | 0 | 45 | 225 | 150% | 45 | 0 | 45 |
| mAMP (500) | | | | | MTD (200) | | | | |
| 0 | NEG | 45 | 45 | 0 | 0 | NEG | 45 | 45 | 0 |
| 100 | 20% | 45 | 45 | 0 | 50 | 25% | 45 | 45 | 0 |
| 250 | 50% | 45 | 27 | 18 | 100 | 50% | 45 | 34 | 11 |
| 375 | 75% | 45 | 13 | 32 | 150 | 75% | 45 | 8 | 37 |
| 625 | 125% | 45 | 1 | 44 | 250 | 125% | 45 | 0 | 45 |
| 750 | 150% | 45 | 2 | 43 | 300 | 150% | 45 | 0 | 45 |
| OPI (100) | | | | | PCP (25) | | | | |
| 0 | NEG | 45 | 45 | 0 | 0 | NEG | 45 | 45 | 0 |
| 25 | 25% | 45 | 45 | 0 | 6.25 | 25% | 45 | 45 | 0 |
| 50 | 50% | 45 | 37 | 8 | 12.5 | 50% | 45 | 31 | 14 |
| 75 | 75% | 45 | 4 | 41 | 18.75 | 75% | 45 | 1 | 44 |
| 125 | 125% | 45 | 0 | 45 | 31.25 | 125% | 45 | 0 | 45 |
| 150 | 150% | 45 | 0 | 45 | 37.5 | 150% | 45 | 0 | 45 |
| THC (50) | | | | | | | | | |
| 0 | NEG | 45 | 45 | 0 | | | | | |
| 25 | 50% | 45 | 45 | 0 | | | | | |
| 37.5 | 75% | 45 | 39 | 6 | | | | | |
| 62.5 | 125% | 45 | 0 | 45 | | | | | |
| 75 | 150% | 45 | 0 | 45 | | | | | |
Table 2. Sensitivity/Precision/ Distribution of Random Error
4
- Other Technical Performance Documentation for the MEDTOXScan® include:
- Influence of Temperature -
- -Influence of Humidity
- -Factory Calibration
- Electrical and EMC Testing -
- Validation and stability of QC Control Cassette ー
- Validation and stability of Cleaning Cassette *
- Analytical specificity (cross reactivity and interference) data are summarized below. .
Related Compounds and Cross Reactants
The following metabolites and reacting compounds were evaluated for the specified test on the PROFILE -V MEDTOXScan® Drugs of Abuse Test System. Reference standards for the various metabolites and compounds were prepared in negative urine samples. Results are expressed as the minimum concentration required to produce a positive result in the indicated assay. Compounds that reacted with the test are listed first, and related compounds that did not react with the highest concentration tested are listed second as Negative at 100,000 ng/mL. The "% Cross-Reactive" values were calculated from the cut-off level for the calibrator used for each test (approximate 50% positive rate) divided by the lowest reported level found to react in the same test (greater than 66% positive rate).
Amphetamine- (AMP) (d-Amphetamine) 500 ng/mL
| Result | % Cross-Reactive | |
|---|---|---|
| Amphetamine- (AMP) (d-Amphetamine) 500 ng/mL | ||
| I-Amphetamine | Positive at 50,000 ng/mL | 1% |
| Fenfluramine | Positive at 10,000 ng/mL | 5% |
| MDA | Positive at 250 ng/mL | 200% |
| Phentermine | Positive at 7,500 ng/mL | 7% |
| Ephedrine | Negative at 100,000 ng/mL | None Detected |
| MDE (MDEA) | Negative at 100,000 ng/mL | None Detected |
| MDMA | Negative at 100,000 ng/mL | None Detected |
| I-Methamphetamine | Negative at 100,000 ng/mL | None Detected |
| d-Methamphetamine | Negative at 100,000 ng/mL | None Detected |
| Phenethylamine | Negative at 100,000 ng/mL | None Detected |
| Pseudoephedrine | Negative at 100,000 ng/mL | None Detected |
| Tyramine | Negative at 100,000 ng/mL | None Detected |
| Barbiturate-(BAR) (Butalbital) 200 ng/mL | ||
| Allobarbital | Positive at 250 ng/mL | 80% |
| Amobarbital | Positive at 800 ng/mL | 25% |
| Barbital | Positive at 2,500 ng/mL | 8% |
| Butabarbital | Positive at 400 ng/mL | 50% |
| Cyclopentobarbital | Positive at 250 ng/mL | 80% |
| Diphenylhydantoin (Phenytoin) | Positive at 2,000 ng/mL | 10% |
| Pentobarbital | Positive at 300 ng/mL | 67% |
| Phenobarbital | Positive at 1,250 ng/mL | 16% |
| Secobarbital | Positive at 50 ng/mL | 400% |
| Talbutal | Positive at 50 ng/mL | 400% |
| Barbituric Acid | Negative at 100,000 ng/mL | None Detected |
| Glutethimide | Negative at 100,000 ng/mL | None Detected |
| Hexobarbital | Negative at 100,000 ng/mL | None Detected |
| Mephobarbital | Negative at 100,000 ng/mL | None Detected |
| Thiopental | Negative at 100,000 ng/mL | None Detected |
5
Benzodiazepine-(BZO)(Nordiazepam) 150 ng/mL
| Benzodiazepine-(BZO)(Nordiazepam) 150 ng/mL | ||
|---|---|---|
| Result | % Cross-Reactive | |
| Alprazolam | Positive at 100 ng/mL | 150% |
| Alprazolam, 1-OH | Positive at 25,000 ng/mL |