The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE® V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOX Scan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOX Scan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. PROFILE®-V MEDTOXScan® Test Devices cannot be visually read.

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings.

The PROFILE® V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations:

AMP Amphetamine (d-Amphetamine) 500 ng/mL
BAR Barbiturates (Butalbital) 200 ng/mL
BZO Benzodiazepines (Nordiazepam) 150 ng/mL
COC Cocaine (Benzoylecgonine) 150 ng/mL
MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL
MTD Methadone (Methadone) 200 ng/mL
OPI Opiates (Morphine) 100 ng/mL
OXY Oxycodone (Oxycodone) 100 ng/mL
PCP Phencyclidine (Phencyclidine) 25 ng/mL
PPX Propoxyphene (Norpropoxyphene) 300 ng/mL
THC Cannabinoids (11-nor-9-carboxy-Δ9-THC) 50 ng/mL
TCA Tricyclic Antidepressants (Desipramine) 300 ng/mL

Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed and previously cleared drug. Refer to specific product labeling for the combination of drug tests included on that test device.

THE PROFILE -V MEDTOXScan® DRUGS OF ABUSE TEST SYSTEM PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL . METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY / MASS SPECTROMETRY (GC/MS), HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) OR LIQUID CHROMATOGRAPHY / TANDEM MASS SPECTROMETRY (LC/MS/MS) ARE THE PREFERRED CONFIRMATORY METHODS. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.

The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan® Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for PROFILE®V MEDTOXScan® Drugs of Abuse Test System

The primary acceptance criteria for the PROFILE®V MEDTOXScan® Drugs of Abuse Test System, as demonstrated in the clinical studies, revolve around its analytical agreement with GC/MS or LC/MS/MS methods for detecting drugs of abuse in urine samples.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" as a distinct section with specific numerical targets (e.g., "sensitivity must be >95%"). However, the clinical study results implicitly define the performance expected for substantial equivalence. The key performance metric is the percentage agreement with confirmed analytical methods (GC/MS or LC/MS/MS) across different concentration ranges.

The relevant performance metrics for the newly added analytes (Oxycodone, Propoxyphene, and Tricyclic Antidepressants) are derived from the clinical accuracy study (Table 5) and the sensitivity/precision study (Table 2).

Implicit Acceptance Criteria and Reported Device Performance (Focus on new analytes):

Metric / Analytes (Cutoff)	Implicit Acceptance Standard (Desired Performance based on context)	Reported Device Performance (Clinical Accuracy, Table 5)	Reported Device Performance (Sensitivity/Precision, Table 2)
Overall Agreement (Positive)	High agreement with confirmatory methods for samples at or above the cutoff.	OXY (100 ng/mL): 98% (3 positives in near cutoff positive, 36 in high positive matched positive)	Not directly applicable; this table focuses on detection rates at specific concentrations relative to cutoff. Values like "0" negatives at 125% and 150% of cutoff, and "45" positives at these levels, indicate high sensitivity above the cutoff.
Overall Agreement (Negative)	High agreement with confirmatory methods for samples below the cutoff.	OXY (100 ng/mL): 100% (40 no-drug negatives, 3 low negative, 4 near cutoff negative matched negative).	Not directly applicable; "45" negatives at 0 ng/mL and 25% of cutoff indicate high specificity below these levels.
PPX (300 ng/mL): 100% (4 positives in near cutoff positive, 40 in high positive matched positive)	PPX (300 ng/mL): 92% (45 no-drug negatives, 1 low negative, 2 near cutoff negative matched negative). Note: There are 4 "near cutoff negative" samples that tested "Positive" by the device, and 2 "near cutoff positive" samples that tested "Negative" by the device (Table 6 clarifies the latter as 2 false negatives above cutoff).
TCA (300 ng/mL): 100% (4 positives in near cutoff positive, 36 in high positive matched positive)	TCA (300 ng/mL): 93% (40 no-drug negatives, 2 low negative, 1 near cutoff negative matched negative).
Performance near Cutoff (Sensitivity)	Demonstrate high positive detection rate for samples at or above the cutoff concentration (e.g., >80% at 75% cutoff, 100% at 125% cutoff).	For Oxycodone, Propoxyphene, and TCA, all "High Positive (greater than +50%)" samples (total 112) were correctly identified as positive.	OXY (100 ng/mL): 75% cutoff (26/45 Pos), 125% cutoff (45/45 Pos), 150% cutoff (45/45 Pos)
Performance near Cutoff (Specificity)	Demonstrate high negative detection rate for samples below the cutoff concentration (e.g., 100% at 0 ng/mL, <20% positive at 75% cutoff).	For Oxycodone, Propoxyphene, and TCA, all "No Drug" samples (total 125) were correctly identified as negative.	PPX (300 ng/mL): 75% cutoff (14/45 Pos), 125% cutoff (43/45 Pos), 150% cutoff (45/45 Pos)
TCA (300 ng/mL): 75% cutoff (36/45 Pos), 125% cutoff (45/45 Pos), 150% cutoff (45/45 Pos)
Low Cross-Reactivity / Interference	Acceptable levels of cross-reactivity with common related compounds and no significant interference from pH, specific gravity, or common drugs.	Summarized in Tables 3 & 4. Specific percent cross-reactivity values are listed for various compounds. No interference was observed from pH, specific gravity, or common drugs at tested conditions.
TCA (300 ng/mL): 75% cutoff (36/45 Pos), 125% cutoff (45/45 Pos), 150% cutoff (45/45 Pos). Note: Table 2 shows some positives (1/45) at 50% cutoff for OXY; some negatives (2/45 and 0/45) at 125% cutoff for PPX.
PPX (300 ng/mL): 50% cutoff (0/45 Pos), 75% cutoff (14/45 Pos), 125% cutoff (2/45 Neg), 150% cutoff (0/45 Neg).
TCA (300 ng/mL): 50% cutoff (0/45 Pos), 75% cutoff (9/45 Neg).

Summary of Discordant Results (Table 6):

OXY (100 ng/mL): 1 false negative at 102 ng/mL (just above cutoff). The clinical study had 1 "near cutoff positive" sample (between cutoff and +50%) that tested negative.
PPX (300 ng/mL): 4 false positives for samples between 182-271 ng/mL (all below cutoff). The clinical study had 4 "near cutoff negative" samples (between 50% and cutoff) that tested positive.
TCA (300 ng/mL): 3 false positives for samples between 194-287 ng/mL (all below cutoff). The clinical study had 3 "near cutoff negative" samples (between 50% and cutoff) that tested positive.

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

Clinical Test Set (Table 5):
- Total samples: 125 (Negative) + 6 (Low negative) + 11 (Near Cutoff Negative) + 12 (Near Cutoff Positive) + 112 (High Positive) = 266 samples across all drugs (OXY, PPX, TCA).
- For Oxycodone (OXY): 40 (No Drug) + 3 (Low Negative) + 4 (Near Cutoff Negative) + 3 (Near Cutoff Positive) + 36 (High Positive) = 86 samples.
- For Propoxyphene (PPX): 45 (No Drug) + 1 (Low Negative) + 2 (Near Cutoff Negative) + 4 (Near Cutoff Positive) + 40 (High Positive) = 92 samples.
- For Tricyclic Antidepressants (TCA): 40 (No Drug) + 2 (Low Negative) + 1 (Near Cutoff Negative) + 4 (Near Cutoff Positive) + 36 (High Positive) = 83 samples.
Sensitivity/Precision Test Set (Table 2):
- Each drug (OXY, PPX, TCA) was tested with 45 observations per concentration level.
- There were 6 concentration levels for OXY and 5 for PPX and TCA, resulting in 270 observations for OXY and 225 observations for PPX and TCA each in this specific study.
Data Provenance: The document states, "The samples were obtained from MEDTOX Laboratories." It doesn't specify the country of origin, but Medtox Diagnostics, Inc. is located in North Carolina, USA, suggesting the data is likely from the USA. The study is described as evaluating a "panel of blind coded clinical urine samples," which indicates it was a retrospective evaluation of existing samples, albeit with the device testing being prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The ground truth for the clinical test set was established by "GC/MS or LC/MS/MS results." These are instrumental analytical methods and do not typically involve human "experts" in the sense of physicians or clinical reviewers for direct interpretation of the primary result. The interpretation of these assays is based on established chemical analysis protocols.
Therefore, the number of experts is not applicable in the traditional sense of clinical opinion, and their specific qualifications are not relevant here, as the comparison is against another laboratory-based analytical method.

4. Adjudication Method for the Test Set

The ground truth was established by GC/MS or LC/MS/MS results. These are definitive chemical confirmatory methods. There is no mention of a human adjudication process (like 2+1, 3+1 consensus) for the ground truth itself, as the chemical analysis provides the "ground truth" concentrations. The device's results were then compared to these confirmed chemical values.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.
This device is an automated reader for immunoassay test strips, and its output is a qualitative positive or negative result. The study involved comparison of the device's automated reading to reference chemical methods (GC/MS or LC/MS/MS), not a comparison of human readers' performance with and without AI assistance. The study explicitly states, "PROFILE®-V MEDTOXScan® Test Devices cannot be visually read."

6. Standalone Performance Study

Yes, a standalone study was done. The entire clinical accuracy study and the sensitivity/precision study (Tables 2 & 5) describe the performance of the algorithm only (the device in its intended use, without human-in-the-loop decision making regarding the test line interpretation). The device "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 results of the scans are displayed on the MEDTOXScan® screen or optionally can be printed." Human operators run the test, but the interpretation is solely by the instrument's algorithm.

7. Type of Ground Truth Used

The ground truth used was instrumental laboratory confirmatory methods: Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). This is a highly accurate and widely accepted method for confirming the presence and concentration of drugs and their metabolites in biological samples. The text refers to it as the "preferred confirmatory methods."

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. The performance studies described are for validation of the device, implying that development and training (if a machine learning component were involved, though this is a rule-based algorithm) would have occurred prior to these studies. The existing analytes (Amphetamines, Barbiturates, etc.) were "previously cleared (K080635)," and "Performance studies have been conducted for the addition of Oxycodone, Propoxyphene, and Tricyclic Antidepressants through Medtox's internal Design Control process." This implies new studies for the added analytes, but no specific training set size is provided.

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

Since the training set size and details are not provided, the method for establishing its ground truth is also not explicitly stated in this document. Given it's a diagnostic device for drugs of abuse, it's highly probable that ground truth for any training would also be established using gold-standard analytical methods like GC/MS or LC/MS/MS, similar to the validation set.

Summary

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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

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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.

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

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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 fromdrug of abuse immunoassay screens.	Same
SystemProcedure	Sample is added to a single use test cassette, which isthen read by instrument. Instrument is designed toread multiple single use test cassettes, one at a time.	Same
MeasurementMethod	Scans the single-use test cassette to detect a signal.	Same
Output	Outputs "positive," "negative," and "invalid" test resultson paper printout or LCD screen; stores and uploadsresults.	Same
Differences
Item	Additional or ExpandedIndications	Predicate, K080635
Analytes	Amphetamines, Barbiturates,Benzodiazepines, Cocaine,Methadone, Methamphetamine,Opiates, Oxycodone,Phencyclidine, Propoxyphene,THC (Cannabinoids), andTricyclic Antidepressants	Amphetamines, Barbiturates,Benzodiazepines, Cocaine,Methadone, Methamphetamine,Opiates, Phencyclidine, and THC(Cannabinoids),
FactoryCalibration	A five point threshold calibrationmethod is used.	A single point + 3 SD thresholdcalibration is used.
Timing Modes	Clinical samples are run ininstrument-timed mode only	Clinical samples are run in eitherinstrument-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.

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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 ExpandedIndications	Predicates: K060351 (OXY); K020387(PPX); K002331 (TCA)
SystemProcedure	Sample is added to a single usetest cassette, which is then readby instrument. Instrument isdesigned to read multiple singleuse test cassettes, one at a time.	Sample is added to a single use testcassette, which is then read visually bythe operator.
MeasurementMethod	Scans the single-use testcassette to detect a signal andcompares to instrumentscalibrate threshold.	Operator visually determines thepresence or absence of a line at the testposition.
Output	Outputs "positive," "negative,"and "invalid" test results onpaper printout or LCD screen;stores and uploads results.	Operator visually determines whethertest is "positive," "negative," or "invalid"and records results manually.
Timing Modes	Instrument internally times teststrip development and scanstest cassette at appropriate time.	Operator manually times testdevelopment and visually reads testcassette at appropriate time.

Table 2. Comparison of Similarities and Differences for the PROFILE -V MEDTOXScan® Drugs of Abuse Test System and predicate visual devices.

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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:

SampleConcentration(ng/mL)	% of Cutoff	Number ofObservations	# 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 -

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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 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 SystemOxycodone (OXY) (Oxycodone) 100 ng/mL
Compound	Result	% Cross-Reactive
Codeine	Positive at 5000 ng/mL	2%
Dihydrocodeine	Positive at 25,000 ng/mL	<1%
Ethylmorphine	Positive at 7,500 ng/mL	1%
Hydrocodone	Positive at 50,000 ng/mL	<1%
Hydromorphone	Positive at 50,000 ng/mL	<1%
Morphine	Positive at 25,000 ng/mL	<1%
Morphine 6-B-D-Glucuronide	Positive at 100,000 ng/mL	<1%
Naloxone	Positive at 25,000 ng/mL	<1%
Norcodeine	Positive at 100,000 ng/mL	<1%
Oxymorphone	Positive at 250 ng/mL	40%
Naltrexone	Positive at 50,000 ng/mL	<1%
Apomorphine	Negative at 100,000 ng/mL	None Detected
Diacetylmorphine	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 3-B-D-Glucuronide	Negative at 100,000 ng/mL	None Detected
Nalorphine	Negative at 100,000 ng/mL	None Detected
Thebaine	Negative at 100,000 ng/mL	None Detected
Propoxyphene-(PPX) (Norpropoxyphene) 300 ng/mL
Compound	Result	% Cross-Reactive
Propoxyphene	Positive at 50 ng/mL	600%
Tricyclic Antidepressant (TCA) (Desipramine) 300 ng/mL
Compound	Result	% Cross-Reactive
Amitriptyline	Positive at 500 ng/mL	60%
Clozapine	Positive at 7,500 ng/mL	4%
Cyclobenzaprine	Positive at 20,000 ng/mL	2%
Doxepin	Positive at 1,300 ng/mL	23%
Imipramine	Positive at 250 ng/mL	120%
Maprotiline	Positive at 300 ng/mL	100%
Nordoxepin	Positive at 700 ng/mL	43%
Nortriptyline	Positive at 500 ng/mL	60%
Perphenazine	Positive at 75,000 ng/mL	<1%
Prochlorperazine	Positive at 50,000 ng/mL	<1%

Table 3. Related Compounds and Cross Reactants in the MEDTOXScan® Drugs of Abuse Test Svstem

P-V MEDTOXScan® Drugs of Abuse Test System 510(k) Summary, May 12, 2009, Page 6 of 9

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Tricyclic Antidepressant (TCA) (Desipramine) 300 ng/mL, continued
Compound	Result	% Cross-Reactive
Promazine	Positive at 900 ng/mL	33%
Protriptyline	Positive at 50,000 ng/mL	<1%
Quetiapine (Seroquel)	Positive at 10,000 ng/mL	3%
Trimipramine	Positive at 5,000 ng/mL	6%
Carbamazepine	Negative at 100,000 ng/mL	None Detected
Carbamazepine-10, 11 epoxide	Negative at 100,000 ng/mL	None Detected
Chlorpromazine	Negative at 100,000 ng/mL	None Detected
Clomipramine	Negative at 100,000 ng/mL	None Detected
Loxapine	Negative at 100,000 ng/mL	None Detected
Mirtazapine	Negative at 100,000 ng/mL	None Detected
Norclomipramine	Negative at 100,000 ng/mL	None Detected
Olanzapine	Negative at 100,000 ng/mL	None Detected
Phenothiazine	Negative at 100,000 ng/mL	None Detected
Thiothixene	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 ³ 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 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 "OXY", 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 triblicate by in-house operators. None of the common drugs listed in Table 4 below affected the expected results.

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

Tahlo 4

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 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. The results are summarized in Table 5 below.

DRUG	P-VMEDTOXScanDrugs of AbuseTest 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
OXY(100)	Positive	0	0	0	3	36	98%
OXY(100)	Negative	40	3	4	1	0	100%
PPX(300)	Positive	0	0	4	4	40	100%
PPX(300)	Negative	45	1	2	0	0	92%
TCA(300)	Positive	0	0	3	4	36	100%
TCA(300)	Negative	40	2	1	0	0	93%
AllDrugs	Positive	0	0	7	11	112	99.2%
AllDrugs	Negative	125	6	7	1	0	95.2%

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

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

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Drug and Cutoff Value(ng/mL)	P-V MEDTOXScan Drugs of AbuseTest System	Drug or MetaboliteGC/MS or LC/MS/MS Value(ng/mL)
OXY (100)	NEG	102
PPX (300)	POS	182
	POS	194
	POS	228
	POS	271
TCA (300)	POS	194
	POS	217
	POS	287

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.

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Image /page/9/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

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

JUL 2 4 2009

Re: K091454

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).

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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/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

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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 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)	500ng/mL	OPI Opiates (Morphine)	100ng/mL
BAR Barbiturates(Butalbital)	200ng/mL	OXY Oxycodone(Oxycodone)	100ng/mL
BZO Benzodiazepines(Nordiazepam)	150ng/mL	PCP Phencyclidine(Phencyclidine)	25ng/mL
COC Cocaine(Benzoylecgonine)	150ng/mL	PPX Propoxyphene(Norpropoxyphene)	300ng/mL
MAMP Methamphetamine(d-Methamphetamine)	500ng/mL	THC Cannabinoids(11-nor-9-carboxy-r9-THC)	50ng/mL
MTD Methadone(Methadone)	200ng/mL	TCA TricyclicAntidepressants(Desipramine)	300ng/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

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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.

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

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).