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.

Device Description

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.

AI/ML Overview

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.

Summary

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100023

APR - 5 2010

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: unknown

Submitted By: Medtox Diagnostics, Inc.
1238 Anthony Road

Burlington, North Carolina 27215

Contact Person: Phillip Hartzog, Ph.D.
Director, Research & Development

Phone: 336-226-6311, ext. 2863

336-229-4471 Fax:

Date Prepared: November 10, 2009

Proprietary Name: PROFILE®-V MEDTOXScan® Drugs of Abuse Test System

Colorimeter, Drugs of Abuse Test System Common Name:

Classification Names:

he applicant test system regulatory classification is Class II; the Classification Panel is Clinical Toxicology (91) and Clinical Chemistry (75). Regulatory information applicable to the test system is provided below:

CFR Section	ProductCode
862.2300, Colorimeter, Photometer, Spectrophotometer forClinical 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, Opiate Test System (Oxycodone)	DJG

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862.3650, Opiate Test System (Buprenorphine)	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

PROFILE®-V MEDTOX Scan® Drugs of Abuse Test System (K091454) Predicate Device:

Description of the Device

Intended Use

The PROFILE®-V MEDTOXScar® 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, Bupreorphine, 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 MEDTOXScar® Reader. The MEDTOX Scan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScar® 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:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		Anne Callery Collection.	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A SUSTANT A SECURATIVE COLLECTITY AN .	And And Property of Children Comments of Children	-------------------And man for the first and the cases

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(d-Amphetamine)	ng/mL		or
BAR Barbiturates (Butalbital)	200ng/mL		2000 ng/mL
BUP Buprenorphine(Buprenorphine)	10 ng/mL	OXY Oxycodone (Oxycodone)	100 ng/mL
BZO Benzodiazepines(Nordiazepam)	150ng/mL	PCP Phencyclidine(Phencyclidine)	25 ng/mL
COC Cocaine (Benzoylecgonine)	150ng/mL	PPX Propoxyphene(Norpropoxyphene)	300 ng/mL
MAMP Methamphetamine(d-Methamphetamine)	500ng/mL	THC Cannabinoids(11-nor-9-carboxy-r9-THC)	50 ng/mL
MTD Methadone (Methadone)	200ng/mL	TCA Tricyclic Antidepressants(Desipramine)	300 ng/mL

Configurations of the PROFILE®-V MEDTOXScar® 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 OC Test Device, a Negative OC 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 MEDTOXScart® Cleaning Cassette effectively removed any contamination (see "Troubleshooting" Section).

Discussion of Technological Characteristics:

a. Similarities and differences to predicate device

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 applicate test devices are rapid single use disposable devices that use immunochromatographic lateral flow technology. Both the applicant and predicate test devices utilize gold-conjugated reagents to generate the reddish-purple test and

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controls lines, which are read by the instrument.

Overall characteristics of the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System and the predicate device are summarized in Table 1 below:

Similarities
Item	Additional or Expanded Indications	Predicate, K091454
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 with contact imaging sensor (CIS) 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, K091454
Analytes	Amphetamines, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants	Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants

Table 1. Comparison of Similarities and Differences for the PROFILE®-V MEDTOXScan®Drugs of Abuse Test System and predicate device.

Performance characteristics for the common analytes are exactly the same and data are on file at Medtox. They have not been altered by the addition of the new analytes.

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 device with regard to the additional analytes. As with previous Medtox submissions, these studies included confirmation of the analyte concentration by use of GC/MS or LC/MS/MS methods:

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:

See K091454 for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates (100 ng/mL), Oxycodone, Phencyclidine, Propoxyphene, THC, Tricyclic

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Antidepressants and (Cannabinoids), Performance studies have been conducted for the addition of Buprenorphine and Opiates (2,000 ng/mL) 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 MEDTOX Scan® Drugs of Abuse Test System around the specific cutoff for Buprenorphine and Opiates (2,000 ng/mL) 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 MEDTOX Scan® Reader and are summarized for each drug in Table 2 below:

SampleConcentration(ng/mL)	% of Cutoff	Number ofObservations	# Neg	# Pos
Opiates (2,000)
0	Neg	45	45	0
1,000	50%	45	45	0
1,500	75%	45	31	14
2,500	125%	45	0	45
3,000	150%	45	0	45
Buprenorphine (10)
0	Neg	45	45	0
5.0	50%	45	45	0
7.5	75%	45	30	15
12.5	125%	45	0	45
15.0	150%	45	0	45

Table 2. Sensitivity/Precision/Distribution of Random Error

Other Technical Performance Documentation for the MEDTOX Scan® 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

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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 Buprenorphine and Opiates (2,000 ng/mL). Reference standards for the various metabolites and compounds were prepared in negative urine samples. Results are expressed as the approximate 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).

Buprenorphine (BUP) (Buprenorphine, 10 ng/mL)
Compound	Result	% Cross-Reactive
Buprenorphine-glucuronide	Positive at 20 ng/mL	50%
Norbuprenorphine	Positive at 250 ng/mL	4%
Norbuprenorphine-glucuronide	Positive at 500 ng/mL	2%
Codeine	Negative at 100,000 ng/mL	None Detected
Diacetylmorphine	Negative at 100,000 ng/mL	None Detected
Hydrocodone	Negative at 100,000 ng/mL	None Detected
Hydromorphone	Negative at 100,000 ng/mL	None Detected
Levorphanol	Negative at 100,000 ng/mL	None Detected
6-Monoacetylmorphine	Negative at 100,000 ng/mL	None Detected
Morphine	Negative at 100,000 ng/mL	None Detected
Naloxone	Negative at 100,000 ng/mL	None Detected
Naltrexone	Negative at 100,000 ng/mL	None Detected
Oxycodone	Negative at 100,000 ng/mL	None Detected
Oxymorphone	Negative at 100,000 ng/mL	None Detected
Thebaine	Negative at 100,000 ng/mL	None Detected
Opiates (OPI) (Morphine, 2,000 ng/mL)
Compound	Result	% Cross-Reactive
Codeine	Positive at 900 ng/mL	222%
Diacetylmorphine	Positive at 2500 ng/mL	80%
Dihydrocodeine	Positive at 3800 ng/mL	53%

Table 3. Related Compounds and Cross Reactants in the MEDTOX Scan® Drugs of Abuse Test System

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Ethylmorphine	Positive at 600 ng/mL	333%
Hydrocodone	Positive at 1400 ng/mL	143%
Hydromorphone	Positive at 1900 ng/mL	105%
Levorphanol	Positive at 5000 ng/mL	40%
6-Monoacetylmorphine	Positive at 3800 ng/mL	53%
Morphine 3-β-D-Glucuronide	Positive at 5000 ng/mL	40%
Morphine 6-β-D-Glucuronide	Positive at 6000 ng/mL	33%
Norcodeine	Positive at 40,000 ng/mL	5%
Thebaine	Positive at 2500 ng/mL	80%
Apomorphine	Negative at 100,000 ng/mL	None Detected
Nalorphine	Negative at 100,000 ng/mL	None Detected
Naloxone	Negative at 100,000 ng/mL	None Detected
Naltrexone	Negative at 100,000 ng/mL	None Detected
Oxycodone	Negative at 100,000 ng/mL	None Detected
Oxymorphone	Negative at 100,000 ng/mL	None Detected

Interference Data

pH and Specific Gravity:

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System was assayed with three negative clinical samples with pH values of 4.0, 7.0 and 9.0 ± 0.1. Each sample was assayed in triplicate. The pH samples were fortified with drug concentrations that were the maximum level to give a strong negative (95% or greater negative) result (10-50% of cut-off, see Sensitivity data), and the minimum level above the cut-off to give a strong positive (95% or greater positive) result (125-150% of cut-off, see Sensitivity data). All three pH 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.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System was assayed with three samples with specific gravity values of 1.003. 1.015 and 1.030 ± 0.001. Each sample was assayed in triplicate. The specific gravity samples were fortified with drug concentrations as described above for pH to give strong negative and strong positive results. 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:

Drug free urine samples were spiked with drug concentrations that were the maximum level to give a strong negative (95% or greater negative) result (10-50% of cut-off, see Sensitivity data), and the minimum level above the cut-off to give a strong positive (95% or greater positive) result (125-150% of

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cut-off. see Sensitivity data). 100,000 ng/mL of the common drugs were then added to the preparation and assaved by the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System. If a common compound name is followed by the abbreviation "OPI", then it has cross-reactivity to the specified drug test (see "Related Compounds and Cross Reactants") and therefore was not assayed for interference for that drug test. Samples were evaluated in triplicate by in-house operators. None of the common drugs listed in Table 4 below affected the expected results.

Acetylsalicylic Acid	Chlorpheniramine	Morphine-OPI
Acetaminophen	Cocaine	Phenobarbital
Brompheniraminemaleate	Dextromethorphan	Phenytoin (Diphenylhydantoin)
Caffeine	Doxylamine	d-Pseudoephedrine
Carbamazepine	Ibuprofen	Salicylic Acid

		Table 4. Common Drugs Evaluated with the MEDTOXScan® Drugs of Abuse Test System
--	--	---------------------------------------------------------------------------------	--	--

Discussion of Clinical Tests Performed for Determination of Substantial Equivalence:

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 were screened negative by KIMS (Kinetic Interaction of Microparticles in Solution), and 10% were confirmed negative 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/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. The results are summarized in Table 5 below.

Table 5.
PROFILE®-V MEDTOXScan® Drugs of Abuse Test System
vs stratified GC/MS or LC/MS/MS Values

DRUG	P-VMEDTOXScanDrugs ofAbuse TestSystem	NoDrug	NearCutoffNegative(between-50% andcutoff)	NearCutoffPositive(Betweencutoff and+50%)	HighPositive(greaterthan+50%)	%Agreement
BUP(10)	Positive	0	0	4	36	100%
(10)	Negative	40	4	0	0	100%
OPI	Positive	0	1	4	36	100%

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(2,000)	Negative	40	4	3	0	0	98%
All	Positive	0	0	1	8	72	100%
Drugs	Negative	80	4	7	0	0	99%

For samples giving preliminary positive results below the cutoff and negative results above the cutoff, the assayed values are detailed in Table 6 below:

Drug and CutoffValue (ng/mL)	P-V MEDTOXScan Drugs ofAbuse Test System	GC/MS or LC/MS/MS Value(Drug or Metabolite, ng/mL)
OPI (2,000)	OPI positive	Morphine at 1,375 ng/mL

Table 6. ACCURACY/SUMMARY of DISCORDANT RESULTS

Conclusions:

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System has the same intended use and similar technological characteristics as the predicate device. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new issues of safety or effectiveness. Thus, the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is substantially equivalent to the predicate device.

Notebook icon

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Medtox Diagnostics, Inc. c/o Phillip Hartzog, Ph.D. Director, R&D 1238 Anthony Road Burlington, NC 27215

APR 0 5 2010

Re: K100023

Trade Name: Profile®-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 Dated: December 31, 2009 Received: January 5, 2010

Dear Dr. 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).

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): unknown

Device Name: PROFILE®-V MEDTOXScan®Drugs of Abuse Test System

Indication(s) For Use:

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 or 2000ng/mL
BAR Barbiturates(Butalbital)	200 ng/mL	OXY Oxycodone(Oxycodone)	100 ng/mL
BUP Buprenorphine(Nordiazepam)	10 ng/mL	PCP Phencyclidine(Phencyclidine)	25 ng/mL
COC Cocaine(Benzoylecgonine	150 mg/mL	PPX Propoxyphene(Norpropoxyphene)	300 ng/mL
MAMPMethamphetamine (d-Methamphetamine)	500 ng/mL	THC (Cannabinoids11-nor-9-carboxy-r9-THC)	50 ng/mL
MTD Methadone(Methadone)	200 ng/mL	TCA TricyclicAntidepressants(Desipramine)	300 ng/mL
AMP Amphetamine (d-Amphetamine)	500 ng/mL	OPI Opiates(Morphine)	100 ng/mL or 2000ng/mL

And/Or

Prescription Use (21 CFR Part 801 Subpart D)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K100023

Over the Counter Use (21 CFR Part 801 Subpart C)

Page 1 of 2

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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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Carol Benam

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K/000223

Over the Counter Use (21 CFR Part 801 Subpart C)

Page 2 of 2

Regulation Number and Section

§ 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).