(67 days)
Not Found
No
The description mentions "Software algorithms" for interpreting line intensities, but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe training or testing of such models. The interpretation appears to be based on predefined thresholds or rules rather than learned patterns.
No
The device is described as an "in vitro diagnostic use" system that detects drugs of abuse in urine, which is for diagnostic purposes, not therapeutic intervention directly.
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 and is intended for professional use only."
- Nature of the Test: The device performs a rapid, qualitative detection of substances (drugs of abuse or their metabolites) in a human sample (urine). This is a classic characteristic of an in vitro diagnostic test, which is performed outside of the body on a biological specimen to provide information about a person's health or condition.
- Purpose: The test is intended to provide a preliminary analytical result for the presence of drugs of abuse, which is a diagnostic purpose.
- Professional Use: While not exclusively defining an IVD, the indication for "professional use only" aligns with the typical use of IVD devices in clinical or laboratory settings.
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 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-delta9-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 drugs. Refer to specific product 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.
Product codes (comma separated list FDA assigned to the subject device)
JJQ, DKZ, DIS, JXM, DIO, DJR, DJC, DJG, LCM, JXN, LDJ, LFG
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 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.
Mentions image processing
Yes, "The MEDTOXScan® reader scans the device and utilizes a contact imaging sensor (CIS) to capture relative line intensities."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only. It is 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
The accuracy of the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System was evaluated by assaying a panel of blind coded clinical urine samples containing varying concentrations of drugs and comparing to GC/MS or LC/MS/MS results. 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 or LC/MS/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; and High Positive samples that were greater than 150% of cutoff concentration. Drug concentrations were assayed by GC/MS or LC/MS/MS. Concentrations used to assign the cutoff ranges for each drug were determined by summing the GC/MS or 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. No false positives were observed in the absence of drug.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-Clinical Tests (Performance, Sensitivity/Precision/Distribution of Random Error, Analytical specificity (cross reactivity and interference), pH and Specific Gravity, Common Drugs interference) and Clinical Tests (Accuracy).
Non-Clinical Tests:
- Performance of the PROFILE® V MEDTOXScan® Drugs of Abuse Test System around the specific cutoff for Oxycodone, Propoxyphene, and TCA:
- Sample Size: 45 determinations for each level (5 different intervals, 3 in-house operators, different readers, in triplicate).
- Key Results: Shows the number of negative and positive observations at various concentrations relative to the cutoff (0%, 25%, 50%, 75%, 125%, 150%). For example, for OXY (100 ng/mL), at 0 ng/mL and 25 ng/mL, all 45 observations were Negative. At 125 ng/mL and 150 ng/mL, all 45 observations were Positive. At 50 ng/mL, 44 Negative and 1 Positive. At 75 ng/mL, 19 Negative and 26 Positive. Similar data provided for PPX and TCA.
- Analytical specificity (cross reactivity and interference):
- Description: Metabolites and reacting compounds evaluated for interference or cross-reactivity with Oxycodone, Propoxyphene, and Tricyclic Antidepressant (TCA). Reference standards prepared in negative urine samples. Results expressed as minimum concentration required to produce a positive result.
- Key Results: Tables show "Result" (e.g., Positive at 5000 ng/mL) and "% Cross-Reactive" for numerous compounds for OXY, PPX, and TCA. Also lists compounds that did not react with the highest concentration tested (100,000 ng/mL).
- pH and Specific Gravity:
- Description: Assayed with three negative clinical samples with pH values of 4.0, 7.0 and 9.0; and specific gravity values of 1.003, 1.015 and 1.030. Samples fortified to give strong negative (10-50% of cut-off) and strong positive (125-150% of cut-off) results.
- Key Results: All three pH samples and all three specific gravity samples gave negative results when fortified to the maximum strong negative level for each drug, and all gave positive results when fortified to the minimum strong positive level for each drug.
- Common Drugs:
- Description: Drug free urine samples spiked with drug concentrations to give strong negative and strong positive results. 100,000 ng/mL of common drugs added. Samples evaluated in triplicate.
- Key Results: None of the common drugs listed (e.g., Acetylsalicylic Acid, Acetaminophen, Caffeine, Ibuprofen) affected the expected results.
Clinical Tests:
- Accuracy Study (PROFILE®-V MEDTOXScan® Drugs of Abuse Test System vs stratified GC/MS or LC/MS/MS Values):
- Description: Evaluation of accuracy by assaying blind coded clinical urine samples with varying drug concentrations, compared to GC/MS or LC/MS/MS results. Samples grouped by concentration relative to cutoff.
- Key Results:
- OXY (100): 98% Agreement for Positive (39/39), 100% Agreement for Negative (47/47).
- PPX (300): 100% Agreement for Positive (44/44), 92% Agreement for Negative (48/52).
- TCA (300): 100% Agreement for Positive (43/43), 93% Agreement for Negative (43/46).
- All Drugs: 99.2% Agreement for Positive (123/124), 95.2% Agreement for Negative (139/146).
- Discordant Results (accuracy/summary): Details listed for specific samples where the MEDTOXScan result was discordant with GC/MS or LC/MS/MS value (e.g., OXY (100) NEG @ 102 ng/mL; PPX (300) POS @ 182, 194, 228, 271 ng/mL; TCA (300) POS @ 194, 217, 287 ng/mL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Agreements based on Clinical Study:
- OXY (100): Positive Agreement 98%, Negative Agreement 100%
- PPX (300): Positive Agreement 100%, Negative Agreement 92%
- TCA (300): Positive Agreement 100%, Negative Agreement 93%
- All Drugs: Positive Agreement 99.2%, Negative Agreement 95.2%
- % Cross-Reactivity: (Reported in Analytical Specificity section for various compounds relative to main analytes)
- Oxymorphone for OXY: 40%
- Propoxyphene for PPX: 600%
- Amitriptyline for TCA: 60%
- Imipramine for TCA: 120%
- Maprotiline for TCA: 100%
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.
K080635, K060351, K020387, K002331
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
§ 862.3650 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).
0
510(k) SUMMARY
IC091454
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: K091454
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: May 12, 2009
Proprietary Name: PROFILE®V MEDTOXScan® Drugs of Abuse Test System
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 |
| 862.3650, Opiates Test System (Oxycodone) | DJG |
| 862.3100, Amphetamine Test System (Phencyclidine) | LCM |
| 862.3700, Propoxyphene Test System | JXN |
| 862.3870, Cannabinoid Test System | LDJ |
| 862.3910, Tricyclic Anti-depressant Drugs Test System | LFG |
Predicate Devices: PROFILE®-V MEDTOXScan® Drugs of Abuse Test System (K080635); MEDTOX® OXYCODONE (K060351); VERDICT == PROPOXYPHENE (K020387); PROFILE -ER (K002331)
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 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,
1
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.
Intended Use
The PROFILE® V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILEC-V MEDTOXScan® 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, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants or their metabolites. The PROFILE® V MEDTOX Scan® Test Devices can only be used with the l MEDTOXScan® Reader. The MEDTOXScan® 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 prescription 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 | OPI Opiates (Morphine) | 100 ng/mL |
|---|---|---|---|
| BAR Barbiturates (Butalbital) | 200 ng/mL | OXY Oxycodone (Oxycodone) | 100 ng/mL |
| BZO Benzodiazepines (Nordiazepam) | 150 ng/mL | PCP Phencyclidine (Phencyclidine) | 25 ng/mL |
| COC Cocaine (Benzoylecgonine) | 150 ng/mL | PPX Propoxyphene | |
| (Norpropoxyphene) | 300 ng/mL | ||
| MAMP Methamphetamine | |||
| (d-Methamphetamine) | 500 ng/mL | THC Cannabinoids | |
| (11-nor-9-carboxy-Δ9-THC) | 50 ng/mL | ||
| MTD Methadone (Methadone) | 200 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.
:
2
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.
Discussion of Technological Characteristics:
Similarities and differences to predicate devices 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. Both the applicate test devices utilize gold-conjugated reagents i to generate the reddish-purple test and controls lines, which are read by the instrument.
Overall characteristics of the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System and the predicate devices are summarized in Tables below:
| Item | Additional or Expanded Indications | Predicate,
K080635 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Determines qualitative positive or negative result from
drug of abuse immunoassay screens. | Same |
| 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. | Same |
| Measurement
Method | Scans the single-use test cassette to detect a signal. | Same |
| Output | Outputs "positive," "negative," and "invalid" test results
on paper printout or LCD screen; stores and uploads
results. | Same |
| Differences | | |
| Item | Additional or Expanded
Indications | Predicate, K080635 |
| Analytes | Amphetamines, Barbiturates,
Benzodiazepines, Cocaine,
Methadone, Methamphetamine,
Opiates, Oxycodone,
Phencyclidine, Propoxyphene,
THC (Cannabinoids), and
Tricyclic Antidepressants | Amphetamines, Barbiturates,
Benzodiazepines, Cocaine,
Methadone, Methamphetamine,
Opiates, Phencyclidine, and THC
(Cannabinoids), |
| Factory
Calibration | A five point threshold calibration
method is used. | A single point + 3 SD threshold
calibration is used. |
| Timing Modes | Clinical samples are run in
instrument-timed mode only | Clinical samples are run in either
instrument-timed or user-timed modes |
Predicate Test System - K080635
Table 1. Comparison of Similarities and Differences for the PROFILE"-V MEDTOXScan® Drugs of Abuse Test System and predicate instrument system.
3
Predicate Devices - K060351 (OXY); K020387 (PPX); K002331 (TCA)
| Item | Additional or Expanded Indications | Predicates |
|---|---|---|
| Intended Use | Determines qualitative positive or negative result from drug of abuse immunoassay screens. | Same |
| Analytes | Additional Analytes: Oxycodone, Propoxyphene, and Tricyclic Antidepressants | Same or Included |
| Cutoffs | Oxycodone at 100ng/mL, Propoxyphene at 300ng/mL, and Tricyclic Antidepressants at 300ng/mL | Same |
| Differences | ||
|---|---|---|
| Item | Additional or Expanded | |
| Indications | Predicates: K060351 (OXY); K020387 | |
| (PPX); K002331 (TCA) | ||
| 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 visually by | ||
| the operator. | ||
| Measurement | ||
| Method | Scans the single-use test | |
| cassette to detect a signal and | ||
| compares to instruments | ||
| calibrate threshold. | Operator visually determines the | |
| presence or absence of a line at the test | ||
| position. | ||
| Output | Outputs "positive," "negative," | |
| and "invalid" test results on | ||
| paper printout or LCD screen; | ||
| stores and uploads results. | Operator visually determines whether | |
| test is "positive," "negative," or "invalid" | ||
| and records results manually. | ||
| Timing Modes | Instrument internally times test | |
| strip development and scans | ||
| test cassette at appropriate time. | Operator manually times test | |
| development and visually reads test | ||
| cassette at appropriate time. |
Table 2. Comparison of Similarities and Differences for the PROFILE -V MEDTOXScan® Drugs of Abuse Test System and predicate visual devices.
:
i
·
.
..
्म
、 ・ ・
:
. :
:"
...
...
4
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
See K080635 for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine, and THC (Cannabinoids), Performance studies have been conducted for the addition of Oxycodone, Propoxyphene, and Tricyclic Antidepressants through Medtox's internal Design Control process. Performance characteristics are exactly the same and data are on file at Medtox.
The following laboratory performance studies were conducted to determine the substantial equivalence of the PROFILE® V MEDTOXScan® Drugs of Abuse Test System to the predicate:
- Performance of the PROFILE® V MEDTOXScan® Drugs of Abuse Test System around the . specific cutoff for Oxycodone, Propoxyphene, and TCA 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 |
|------------------------------------|-------------|---------------------------|-------|-------|
| OXY (100) | | | | |
| 0 | Neg | 45 | 45 | 0 |
| 25 | 25% | 45 | 45 | 0 |
| 50 | 50% | 45 | 44 | 1 |
| 75 | 75% | 45 | 19 | 26 |
| 125 | 125% | 45 | 0 | 45 |
| 150 | 150% | 45 | 0 | 45 |
| PPX (300) | | | | |
| 0 | Neg | 45 | 45 | 0 |
| 150 | 50% | 45 | 45 | 0 |
| 225 | 75% | 45 | 31 | 14 |
| 375 | 125% | 45 | 2 | 43 |
| 450 | 150% | 45 | 0 | 45 |
| TCA (300) | | | | |
| 0 | Neg | 45 | 45 | 0 |
| 150 | 50% | 45 | 45 | 0 |
| 225 | 75% | 45 | 9 | 36 |
| 375 | 125% | 45 | 0 | 45 |
| 450 | 150% | 45 | 0 | 45 |
Table 2. Sensitivity/Precision/Distribution of Random Error
- · 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 -
- Validation and stability of Cleaning Cassette -
5
- Analytical specificity (cross reactivity and interference) data are summarized below. .
Related Compounds and Cross Reactants
The metabolites and reacting compounds shown in Table 3 below were evaluated on the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System for interference or cross reactivity with Oxycodone, Propoxyphene, and Tricyclic Antidepressent (TCA). Reference standards for the various metabolites and compounds were prepared in neqative 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).
| in the MEDTOXScan TM Drugs of Abuse Test System
| Oxycodone (OXY) (Oxycodone) 100 ng/mL | ||
|---|---|---|
| Compound | Result | % Cross-Reactive |
| Codeine | Positive at 5000 ng/mL | 2% |
| Dihydrocodeine | Positive at 25,000 ng/mL | Trade Name: Profiles®-V MedtoxScan® Drugs of Abuse Test System Regulation Number: 21 CFR §862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Codes: DJG, JXN, LFI Dated: May 15, 2009 Received: May 18, 2009 |
Dear Mr. Hartzog:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
10
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
$\mathscr{A}$ C. $\mathscr{H}$
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known): K091454
Device Name: PROFILE®-V MEDTOXScan® Drugs of Abuse Test System
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 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 | OPI Opiates (Morphine) | 100
ng/mL |
|---------------------------------------------|--------------|---------------------------------------------------|--------------|
| BAR Barbiturates
(Butalbital) | 200
ng/mL | OXY Oxycodone
(Oxycodone) | 100
ng/mL |
| BZO Benzodiazepines
(Nordiazepam) | 150
ng/mL | PCP Phencyclidine
(Phencyclidine) | 25
ng/mL |
| COC Cocaine
(Benzoylecgonine) | 150
ng/mL | PPX Propoxyphene
(Norpropoxyphene) | 300
ng/mL |
| MAMP Methamphetamine
(d-Methamphetamine) | 500
ng/mL | THC Cannabinoids
(11-nor-9-carboxy-r9-THC) | 50
ng/mL |
| MTD Methadone
(Methadone) | 200
ng/mL | TCA Tricyclic
Antidepressants
(Desipramine) | 300
ng/mL |
Confiqurations/of the PROFILE®-V MEDTOXScan® Test Devices may consist of any on offthe above listed and previously cleared drugs. Refer to specific product combination of drug tests included on that test device.
Office of In Vitro Diagnostic Device Evaluation and Sc
510(k)
Page 1 of 2
12
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ivision Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K091454
Page 2 of 2