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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the PROFILE® V MEDTOXScan® Drugs of Abuse Test System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its ability to accurately detect the presence or absence of specific drugs of abuse at defined cutoff concentrations. The performance is reported as the percentage agreement with GC/MS or LC/MS/MS results for clinical urine samples.

Drug / Analyte (Cutoff)	Acceptance Criteria (Implicit)	Reported Device Performance (% Agreement)	Notes
AMP Amphetamine (500 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 96%Negative: 92%	Some discordance near cutoff.
BAR Barbiturates (200 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 100%Negative: 94%	Some discordance near cutoff.
BZO Benzodiazepines (150 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 100%Negative: 98%	Some discordance near cutoff.
COC Cocaine (150 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 97%Negative: 97%	Some discordance near cutoff.
MAMP Methamphetamine (500 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 98%Negative: 98%	Some discordance near cutoff.
MTD Methadone (200 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 98%Negative: 96%	Some discordance near cutoff.
OPI Opiates (100 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 100%Negative: 94%	Some discordance near cutoff.
PCP Phencyclidine (25 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 100%Negative: 93%	Some discordance near cutoff.
THC Cannabinoids (50 ng/mL)	High agreement with GC/MS or LC/MS/MS around cutoff and extreme concentrations.	Positive: 100%Negative: 96%	Some discordance near cutoff.
All Drugs Combined	Overall high agreement with GC/MS or LC/MS/MS.	Positive: 98.5%Negative: 95.3%

2. Sample Size Used for the Test Set and Data Provenance

The "Clinical Tests" section describes the evaluation of a "panel of blind coded clinical urine samples." The sample sizes for each drug are:

AMP: 40 negative, 5 low negative, 0 near cutoff negative, 4 positive (between -50% and cutoff), 5 positive (between cutoff and +50%), 41 high positive = 95 samples
BAR: 40 negative, 3 low negative, 2 near cutoff negative, 3 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 36 high positive = 88 samples
BZO: 40 negative, 3 low negative, 3 near cutoff negative, 1 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 41 high positive = 92 samples
COC: 56 negative, 1 low negative, 5 near cutoff negative, 2 positive (between -50% and cutoff), 4 positive (between cutoff and +50%), 52 high positive = 120 samples
mAMP: 40 negative, 4 low negative, 3 near cutoff negative, 1 positive (between -50% and cutoff), 3 positive (between cutoff and +50%), 40 high positive = 91 samples
MTD: 40 negative, 4 low negative, 2 near cutoff negative, 2 positive (between -50% and cutoff), 3 positive (between cutoff and +50%), 40 high positive = 91 samples
OPI: 46 negative, 2 low negative, 3 near cutoff negative, 3 positive (between -50% and cutoff), 5 positive (between cutoff and +50%), 44 high positive = 103 samples
PCP: 40 negative, 0 low negative, 1 near cutoff negative, 0 positive (between -50% and cutoff), 2 positive (between cutoff and +50%), 20 high positive = 63 samples
THC: 40 negative, 0 low negative, 4 near cutoff negative, 0 positive (between -50% and cutoff), 7 positive (between cutoff and +50%), 30 high positive = 81 samples

Data Provenance: The samples were obtained from MEDTOX Laboratories. The study is retrospective, as it uses a "panel of blind coded clinical urine samples" which implies pre-collected samples. The country of origin is not explicitly stated, but MEDTOX Diagnostics, Inc. is located in North Carolina, USA, and MEDTOX Laboratories is a US-based company, suggesting the data is likely from the USA.

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 using Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). These are analytical laboratory methods, not human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" does not directly apply to the primary ground truth determination in this study. The "in-house operators" who performed the testing using the device would be trained laboratory personnel, but their role was to operate the device and not to establish the ground truth.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus with human readers) is mentioned. The ground truth was established by GC/MS or LC/MS/MS, which are considered definitive analytical methods for drug detection and quantification. Discordant results (where the device result didn't match the GC/MS/LC/MS/MS result) are detailed in Table 5, but there's no mention of an adjudication process by human experts for these cases beyond the initial GC/MS or LC/MS/MS determination.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an automated reader for an immunoassay, not an AI system designed to assist human readers in image interpretation or diagnosis. The study assessed the device's performance against a gold standard (GC/MS/LC/MS/MS), not its impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance study was conducted. The PROFILE® V MEDTOXScan® Reader is an automated instrument that interprets the results of the immunochromatographic test devices. The study evaluates the performance of this automated system in interpreting results without human intervention in the interpretation step. The "in-house operators" perform the technical steps of running the test devices and operating the reader, but the result interpretation is done by the reader's software algorithms.

7. The Type of Ground Truth Used

The primary ground truth used for the clinical test set was analytical confirmation by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). These are considered the gold standard methods for drug detection and quantification in urine.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The studies described are primarily performance evaluation studies (e.g., around cutoff, cross-reactivity, interference, and clinical accuracy). While the device uses "software algorithms," there's no information provided about a specific "training set" used to develop or refine these algorithms. The device likely relies on predefined logic and calibration rather than a machine learning model trained on a large dataset in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Since a distinct "training set" with ground truth establishment for algorithm learning is not mentioned in the document, this information is not provided. The device's operation is based on reading relative line intensities using a contact imaging sensor and applying software algorithms, implying fixed logic and potentially factory calibration rather than a learned model from a training set. The "Sensitivity/Precision/Distribution of Random Error" study (Table 2) uses standard drug solutions at various concentrations, which would be known values, and could be considered part of the development and characterization of the device's reading capabilities, analogous to establishing parameters rather than training a machine learning model.

Summary

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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 RoadBurlington, 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

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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).

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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 abuseimmunoassay screens.	Determines qualitative positive or negative result from drug of abuseimmunoassay screens.
SystemProcedure	Sample is added to a single use test cassette, which is then read byinstrument. Instrument is designed to read multiple single use testcassettes, one at a time.	Sample is added to a single use test cassette, which is then read byinstrument. Instrument is designed to read multiple single use testcassettes, one at a time.
MeasurementMethod	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 paperprintout or LCD screen.	Outputs "positive, "and "negative,"test results on paper printout.

Differences
Item	Device	Predicate
Single-UseTest Cassette	Produces colored lines on device.	Produces a fluorescent signal that isnot visible to the instrument operator.
Assay Type	Competitive assay whereconcentration of drug is inverselyrelated to the visible signaldetected by the instrument.	Competitive assay whereconcentration of drug is inverselyrelated to the fluorescent signaldetected by the instrument.
DetectionMethod	Measures reflectance of visiblelines on single use test cassette.	Measures fluorescent signal on singleuse 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:

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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:

SampleConcentration(ng/mL)	% ofCutoff	Number ofObservations	#Neg	#Pos	SampleConcentration(ng/mL)	% ofCutoff	Number ofObservations	# 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

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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

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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	<1%
Clobazam	Positive at 75 ng/mL	200%
Clonazepam	Positive at 900 ng/mL	17%
Clorazepate	Positive at 200 ng/mL	75%
Desalkylflurazepam	Positive at 600 ng/mL	25%
Desmethylchlordiazepoxide	Positive at 1,000 ng/mL	15%
Desmethylflunitrazepam	Positive at 75 ng/mL	200%
Diazepam	Positive at 75 ng/mL	200%
Flunitrazepam	Positive at 50 ng/mL	300%
Lorazepam	Positive at 1,200 ng/mL	13%
Lorazepam glucuronide	Positive at 1,000 ng/mL	15%
Midazolam	Positive at 5,000 ng/mL	3%
Nitrazepam	Positive at 50 ng/mL	300%
Oxazepam	Positive at 200 ng/mL	75%
Oxazepam glucuronide	Positive at 2,500 ng/mL	6%
Temazepam	Positive at 90 ng/mL	167%
Temazepam glucuronide	Positive at 750 ng/mL	20%
Triazolam	Positive at 750 ng/mL	20%
Triazolam, 1-OH	Positive at 10,000 ng/mL	2%
7-Aminoclonazepam	Negative at 100,000 ng/mL	None Detected
7-Aminoflunitrazepam	Negative at 100,000 ng/mL	None Detected
Chlordiazepoxide	Negative at 100,000 ng/mL	None Detected
Flurazepam	Negative at 100,000 ng/mL	None Detected

Cocaine-(COC) (Benzoylecgonine) 150 ng/mL

	Result	% Cross-Reactive
Cocaine	Positive at 250 ng/mL	60%
Ecgonine	Negative at 100,000 ng/mL	None Detected
Ecgonine Methyl Ester	Negative at 100,000 ng/mL	None Detected

Methamphetamine-(mAMP) (d-Methamphetamine) 500 ng/mL

	Result	% Cross-Reactive
Ephedrine	Positive at 2,500 ng/mL	20%
Fenfluramine	Positive at 50,000 ng/mL	1%
MDE (MDEA)	Positive at 7,500 ng/mL	7%
MDMA	Positive at 1,150 ng/mL	43%
I-Methamphetamine	Positive at 7,500 ng/mL	7%
Phenethylamine	Positive at 2,500 ng/mL	20%
Phenylephrine	Positive at 25,000 ng/mL	2%
Procaine	Positive at 7,500 ng/mL	7%
d-Amphetamine	Negative at 100,000 ng/mL	None Detected
I-Amphetamine	Negative at 100,000 ng/mL	None Detected
MDA	Negative at 100,000 ng/mL	None Detected
Phentermine	Negative at 100,000 ng/mL	None Detected
Phenmetrazine .	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

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Methadone-(MTD) (Methadone) 200 ng/mL

Buprenorphine (MTD Replacement) EDDP (Primary metabolite) EMDP (Secondary metabolite)

Result

Negative at 100,000 ng/mL Negative at 100,000 ng/mL Negative at 100,000 ng/mL

Positive at 50 ng/mL

Positive at 75 ng/mL

Positive at 50 ng/mL

Positive at 400 ng/mL

Positive at 800 ng/mL

Positive at 350 ng/mL

Positive at 500 ng/mL Positive at 50,000 ng/mL

Positive at 10.000 ng/mL

Positive at 25,000 ng/mL

Negative at 100,000 ng/mL

Negative at 100,000 ng/mL Negative at 100,000 ng/mL

Negative at 100,000 ng/mL

Positive at 75 ng/mL

Positive at 2,500 ng/mL

% Cross-Reactive None Detected None Detected None Detected

% Cross-Reactive

200%

133%

200%

25%

13%

29%

133%

20%

<1%

None Detected

Opiates-(OPI) (Morphine) 100 ng/mL

Codeine DiacetyImorphine Dihydrocodeine Ethylmorphine Hydrocodone Hydromorphone Levorphanol 6-MonoacetyImorphine Morphine 3-B-D-Glucuronide Morphine 6-B-D-Glucuronide Nalorphine Norcodeine Thebaine

Apomorphine Naloxone Naltrexone Oxycodone Oxymorphone

Phencvclidine-(PCP) (Phencyclidine) 25 na/mL

	Result	% Cross-Reactive
4-Hydroxyphencyclidine	Positive at 7,500 ng/mL	<1%

Cannabinoids-(THC) (11-Nor-9-carboxy-d -THC) 50 ng/mL

	Result	% Cross-Reactive
Δ9-Tetrahydrocannabinol·	Positive at 100,000 ng/mL	<1%
Cannabidiol	Negative at 100,000 ng/mL	None Detected
Cannabinol	Negative at 100,000 ng/mL	None Detected
L-11-Hydroxy-Δ9-THC	Negative at 100,000 ng/mL	None Detected
Δ8-Tetrahydrocannabinol	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.

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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 cut-off, see Sensitivity data). 100,000 ng/mL of the common drugs were then added to the preparation and assayed by the PROFILE® V MEDTOXScan® Drugs of Abuse Test System. If a common compound name is followed by the abbreviation "COC", "BAR" or "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 the following table affected the expected results.

with the PROFILE®-V MEDTOXScan® Drugs of Abuse Test System
Acetylsalicylic Acid	Chlorpheniramine	Morphine - OPI
Acetaminophen	Cocaine - COC	Phenobarbital - BAR
Brompheniramine maleate	Dextromethorphan	Phenytoin (Diphenylhydantoin) - BAR
Caffeine	Doxylamine	d-Pseudoephedrine
Carbamazepine	Ibuprofen	Salicylic Acid

Table 3. Common Drugs Evaluated

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 that screened neqative 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; and High Positive samples that were greater than 150% of cutoff concentrations were assaved by GC/MS or LC/MS/MS 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. No false positives were observed in the absence of drug. The results are summarized in Table 4 below.

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vs stratified GC/MS or LC/MS/MS Values
DRUG	P-VMEDTOXScanTest System	NoDrug	Low negativeby GC/MS orLC/MS/MS(Less than-50%)	Near CutoffNegative(between-50% andcutoff)	Near CutoffPositive(Betweencutoff and+50%)	HighPositive(greaterthan+50%)	%Agreement
AMP(500)	Positive	0	0	4	5	41	96%
AMP(500)	Negative	40	5	0	2	0	92%
BAR(200)	Positive	0	0	3	4	36	100%
BAR(200)	Negative	40	3	2	0	0	94%
BZO(150)	Positive	0	0	1	4	41	100%
BZO(150)	Negative	40	3	3	0	0	98%
COC(150)	Positive	0	0	2	4	52	97%
COC(150)	Negative	56	1	5	1	1	97%
mAMP(500)	Positive	0	0	1	3	40	98%
mAMP(500)	Negative	40	4	3	1	0	98%
MTD(200)	Positive	0	0	2	3	40	98%
MTD(200)	Negative	40	4	2	1	0	96%
OPI	Positive	0	0	3	5	44	100%

94%

100%

93%

100%

96%

98.5%

95.3%

Table 4. PROFILE®-V MEDTOXScan® Drugs of Abuse System Results

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

357

(100)

РСР

(25)

THC

(50)

All

Drugs

Negative

Positive

Negative

Positive

Negative

Positive

Negative

382

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CutoffValue(ng/mL)	P-VMEDTOXScan TestSystem	Drug or MetaboliteGC/MS or LC/MS/MS Value (ng/mL)
500	AMP positive	Amphetamine at 277ng/mL
	AMP positive	Amphetamine at 352ng/mL
	AMP positive	Amphetamine at 368ng/mL
	AMP positive	Amphetamine at 463ng/mL
500	AMP negative	Amphetamine at 504ng/mL
	AMP negative	Amphetamine at 667ng/mL
200	BAR positive	Butalbital at 126ng/mL
	BAR positive	Butalbital at 159ng/mL
	BAR positive	Butalbital at 184ng/mL
150	BZO positive	Alprazolam at 146ng/mL
150	COC positive	Benzoylecgonine at 114ng/mL
	COC positive	Benzoylecgonine at 121ng/mL
150	COC negative	Benzoylecgonine at 180ng/mL
	COC negative	Benzoylecgonine at 278ng/mL
500	mAMP positive	Methamphetamine at 483ng/mL
500	mAMP negative	Methamphetamine at 554ng/mL
200	MTD positive	Methadone at 148ng/mL
	MTD positive	Methadone at 176ng/mL
200	MTD negative	Methadone at 250ng/mL
100	OPI positive	Morphine at 51ng/mL
	OPI positive	Morphine at 79ng/mL
	OPI positive	Morphine at 92ng/mL
25	PCP positive	Phencyclidine at 19ng/mL
	PCP positive	Phencyclidine at 21ng/mL
	PCP positive	Phencyclidine at 24ng/mL
50	THC positive	11-nor-9-carboxy-Δ9-THC at 35ng/mL
	THC positive	11-nor-9-carboxy-Δ9-THC at 39ng/mL

Table 5. 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.

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Image /page/10/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized depiction of an eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

。

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 1 3 2009

Re: K080635

Trade/Device Name: Profile -V MedToxScan Drugs of Abuse Test System Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJC, DJR; DJG, LCM and JJQ Dated: January 15, 2009 Received: January 16, 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 Fitle 21, Code of Federal Resplations (0)M), Parts 800 to 893. In adestion, 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page - 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Cory C. He

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

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Indication for Use

510(k) Number (if known): K080635

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

Indication 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.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

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

		PLEASE DO NOT WRITE BEEGW THIS LINE: CONTINUE ON ANOTHER PAGESF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ulla Muir

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080635

Page 1 of 2

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Indication for Use

510(k) Number (if known): K080635

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

Indication For Use:

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.

Prescription Use X And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Viola May

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080635

Regulation Number and Section

§ 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).