PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM

K091454 · Medtox Diagnostics, Inc. · DJG · Jul 24, 2009 · Clinical Toxicology

Device Facts

• Record ID: K091454
• Device Name: PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
• Applicant: Medtox Diagnostics, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

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

Device Story

System comprises single-use immunochromatographic test cassettes and MEDTOXScan Reader. Urine sample applied to cassette; reader uses contact imaging sensor (CIS) to capture line intensities. Software identifies device type/analytes via barcode; interprets presence/absence of colored lines as positive/negative/invalid. Results displayed on screen or printed. Used in professional laboratory settings; not for point-of-care. Provides preliminary analytical results; requires confirmation by GC/MS, HPLC, or LC/MS/MS. Benefits include automated, objective interpretation of lateral flow assays, reducing operator subjectivity compared to visual reading.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated using spiked urine samples (n=45 per level). Analytical specificity assessed via cross-reactivity studies with structurally similar compounds and common medications. Method comparison performed against GC/MS or LC/MS/MS on clinical urine samples; results demonstrated concordance with reference methods. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay using gold-conjugated reagents. System includes disposable test cassettes and an instrument reader with a contact imaging sensor (CIS). Connectivity includes result storage and upload capability. Calibration uses a five-point threshold method. System includes QC and cleaning cassettes for sensor maintenance.

Indications for Use

Indicated for the rapid, qualitative detection of drugs of abuse or their metabolites in human urine. Target analytes include Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC, and Tricyclic Antidepressants. Intended for prescription use in clinical settings; not for point-of-care use. Provides preliminary analytical results; requires confirmation by GC/MS, HPLC, or LC/MS/MS.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• PROFILE®-V MEDTOXScan® Drugs of Abuse Test System (k080635)
• MEDTOX® Oxycodone (k060351)
• VERDICT-II Propoxyphene (k020387)
• PROFILE-ER (k002331)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k091454

B. Purpose for Submission:
Addition of 3 new drugs of abuse tests (oxycodone, tricyclics antidepressants and propoxyphene) to an already cleared reader. Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine and THC assays were previously cleared on the reader.

C. Measurand:
Oxycodone, tricyclic antidepressants, and propoxyphene.

D. Type of Test:
Qualitative immunochromatographic test for drugs of abuse in urine performed on a reader.

E. Applicant:
Medtox Diagnostics, Inc.

F. Proprietary and Established Names:
PROFILE®-V MEDTOXScan®

G. Regulatory Information:
1. Regulation section:
21 CFR 862.3650 Opiate test system
21 CFR 862.3700 Propoxyphene test system
21 CFR 862.3910 Tricyclic antidepressant drugs test system
2. Classification:
Class II
3. Product code:
DJG, Enzyme Immunoassay Opiates

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JXN, Enzyme Immunoassay, Propoxyphene.

LFI, High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs

4. Panel:

91, Toxicology

H. Intended Use:

1. Intended use(s):

See indications for use statement below.

2. Indication(s) for use:

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

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for 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-r9-THC) | 50 ng/mL |
| MTD Methadone | 200 | TCA Tricyclic | 300 ng/mL |

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| (Methadone) | ng/mL | Antidepressants
(Desipramine) |
| --- | --- | --- |

Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed and previously cleared drugs. Refer to specific product 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.

3. Special conditions for use statement(s):

The device is for in vitro diagnostic prescription use.

The assay is not designated for use in point-of-care settings.

The PROFILE®-V MEDTOXScan® Test Devices cannot be visually read.

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.

4. Special instrument requirements:

PROFILE®-V MEDTOXScan®

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I. Device Description:

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System includes an instrument and drugs of abuse cassettes that detect specific drugs in urine. The PROFILE®-V MEDTOXScan® Test Device includes antibody-colloidal gold, drug-conjugates and a control line. A test line will form when drug in the sample is below the detection threshold (negative result). The MEDTOXScan® Reader scans the test device and utilizes a contact imaging sensor (CIS) to capture relative line intensities. Software algorithms and barcodes are used to identify the test device, the drug tests associated with the test device and whether the presence or absence of a line is associated with a negative or positive result, respectively.

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.

J. Substantial Equivalence Information:

1. Predicate device name(s):

PROFILE®-V MEDTOXScan® Drugs of Abuse Test System, MEDTOX® Oxycodone, VERDICT-II Propoxyphene, PROFILE-ER.

2. Predicate K number(s):

k080635, k060351, k020387 and k002331 respectively.

3. Comparison with predicate:

The submission is the exact device as the predicate.

The differences are the number of drugs detected, calibration points and timing modes—see table below.

| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine, THC, Tricyclics Antidepressants, Propoxyphene and Oxycodone, | Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine and THC. |
| Calibration | 5-point calibration method is used | A single point +3SD threshold calibration is used. |
| Timing Modes | Clinical samples are run in instrument-time mode only | Clinical samples are run in either instrument-timed or user-times modes. |

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K. Standard/Guidance Document Referenced (if applicable):

The sponsor references the following guidance document in their submission:

CLSI Guidance EP-12A User Protocol for the Evaluation of Qualitative Test Performance.

L. Test Principle:

The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System includes a competitive, membrane-based immunochromatographic PROFILE®-V MEDTOXScan® Test Device and the MEDTOXScan® Reader.

Antibody-Colloidal Gold: Mouse monoclonal antibodies bind to the drug being tested.

Drug-Conjugates: Each drug to be tested was individually conjugated to bovine serum albumin (BSA) or IgG. Each drug conjugate is immobilized on a test line at a designated position on the membrane strip.

Control Line: Each test strip has anti-mouse antibody immobilized at the Control (C) position of the membrane strip. The anti-mouse antibody will bind excess antibody-colloidal gold, indicating that the reagents are migrating properly. When the urine sample is placed in the sample well of a test strip, the dried antibody-colloidal gold under the sample pad dissolves and the urine wicks up the white strips carrying the reddish-purple antibody-colloidal gold with it.

Negative Samples

When no drug(s) is present in the urine sample, the reddish purple antibody-colloidal gold solutions migrate along the strip and bind to the respective drug conjugate(s) immobilized on the membrane. Each strip has up to 4 drug test lines labeled T1 – T4. The binding of the antibody-colloidal gold to the drug conjugate generates a line at the corresponding test (T) position on the strip. The MEDTOXScan® Reader will scan each test position and if a line is detected it will return “NEG” on the display screen (or print out) next to the abbreviation for the drug test, indicating a negative result.

Positive Samples

When drug(s) is present in the urine sample the antibody-colloidal gold binds to the drug(s) before it migrates along the strip. When the antibody colloidal gold binds to the drug(s) in the urine, it cannot bind to the drug conjugate immobilized on the membrane and no line is generated at the drug specific position in the result window. The MEDTOXScan® Reader will scan each test position and if no line is detected it will return “POS” on the display screen (or print out) next to the abbreviation for the drug test, indicating a preliminary positive result.

Control Line (Valid or Invalid results)

Each test strip has an internal procedural control. A line must form at the Control (C)

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position in the result window to indicate that sufficient sample was applied and that the reagents are migrating properly. If a Control line does not form, the test is invalid. The MEDTOXScan® Reader scans each control line and returns “VALID” to the right of the drug test result to confirm that the control line was detected. If no control line is detected it will return “INVALID” on the display screen next to the abbreviation for the invalid drug test, and no result will be given for the drug test.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Urine stock solutions were prepared for each of the test compounds by spiking standard solution of known concentrations into a commercially available negative pool of urine (pH range of 6-7 and Specific Gravity range of 1.012 - 1.018). Each stock solution was assayed by GC/MS or LC/MS/MS. The 150% cutoff sample was serially diluted to form the next lower level in the study. The prepared diluted samples were re-checked additionally by GC/MS or LC/MS/MS to confirm concentrations. A total of 45 results (3 readers x 3 aliquots for 5 days) were obtained for each level.

| Oxycodone (Oxycodone) Cutoff=100 ng/ml | | | | |
| --- | --- | --- | --- | --- |
| Conc. (ng/mL) | % of Cutoff | Number Tested | Positive | Negative |
| 0 | Neg | 45 | 0 | 45 |
| 25 | 25% | 45 | 0 | 45 |
| 50 | 50% | 45 | 1 | 44 |
| 75 | 75% | 45 | 26 | 19 |
| 125 | 125% | 45 | 45 | 0 |
| 150 | 150% | 45 | 45 | 0 |
| Propoxyphene (Norpropoxyphene) Cutoff=300 ng/mL | | | | |
| --- | --- | --- | --- | --- |
| Conc. (ng/mL) | % of Cutoff | Number Tested | Positive | Negative |
| 0 | Neg | 45 | 0 | 45 |
| 150 | 50% | 45 | 0 | 45 |
| 225 | 75% | 45 | 14 | 31 |
| 375 | 125% | 45 | 43 | 2 |
| 450 | 150% | 45 | 45 | 0 |
| Tricyclics Antidepressants (Desipramine) Cutoff=300 ng/mL | | | | |
| --- | --- | --- | --- | --- |
| Conc. (ng/mL) | % of Cutoff | Number Tested | Positive | Negative |
| 0 | Neg | 45 | 0 | 45 |
| 150 | 50% | 45 | 0 | 45 |
| 225 | 75% | 45 | 36 | 9 |

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b. Linearity/assay reportable range:

Not applicable. This assay is intended for qualitative use.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Profile V quality control materials were previously cleared and are sold separately. The sponsor specifies the quality control product in the “materials required but not provided” section of the labeling.

No calibrators are required. The device is calibrated during the manufacturing process.

d. Detection limit:

Sensitivity of qualitative assays may be characterized by validating performance around the claimed cutoff concentration of the assay, and demonstrating the lowest concentration of drug that is capable of or consistently producing a positive result. This information appears in the precision section, 1.a., above.

e. Analytical specificity:

Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into drug-free urine. The tables below summarize the results of cross-reactivity studies using various common and structurally similar compounds. Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. (or, if no cross-reactivity was observed, then “none detected” is reported).

| Oxycodone (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-β-D-Glucuronide | Positive at 100,000 ng/mL | <1% |
| Naloxone | Positive at 25,000 ng/mL | <1% |
| Naltrexone | Positive at 50,000 ng/mL | <1% |

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| Oxycodone (OXY) (Oxycodone) 100 ng/mL | | |
| --- | --- | --- |
| Norcodeine | Positive at 100,000 ng/mL | <1% |
| Oxymorphone | Positive at 250 ng/mL | 40% |
| 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-β-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% |
| 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 |

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Thiothixene

Negative at
100,000\mathrm{ng / mL}

None Detected

## Non Cross-reactive endogenous compounds

The following compounds were evaluated for reactivity with the Profile V device at $100\mathrm{ug / mL}$ (albumin was evaluated at $20\mathrm{mg / mL}$ and bilirubin was evaluated at $200\mathrm{ug / mL}$ ). Samples were evaluated in triplicate by in-house operators. The listed compounds gave negative results with the Profile V device.

| Acetaldehyde | Creatinine | Hemoglobin, Human |
| --- | --- | --- |
| Acetone | Epinephrine | Sodium Chloride |
| Albumin, Human | b-Estradiol | Tetrahydrocortisone |
| Bilirubin | Estriol | d, 1-Thyroxine |
| Cholesterol | Glucose Std. | Uric Acid |

## Unrelated Compounds, Prescription and Over-the-counter Medication

Common compounds were evaluated for reactivity at $100\mathrm{ug / mL}$ . Samples were evaluated in triplicate by in-house operators and the list of compounds evaluated appears in the package insert.

## Common Drugs

Drug free urine samples were spiked with the Profile V targeted drugs to the concentrations of $50\%$ and $125\%$ of the cutoff concentrations. $100~\mathrm{ug / mL}$ of the common drugs listed below, were then added to the preparation and assayed. Evaluations were performed in triplicate by in-house operators. None of the common drugs listed in the following table affected the expected results.

| Acetylsalicylic Acid | Chlorpheniramine | Morphine-OXY |
| --- | --- | --- |
| Acetaminophen | Cocaine | Phenobarbital |
| Brompheniramine Maleate | Dextromethorphan | Phenytoin |
| Caffeine | Doxylamine | d-Pseudoephedrine |
| Carbamazepine | Ibuprofen | Salicylic Acid |

There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results.

## pH and Specific Gravity:

To test for possible positive and/or negative interference from pH, the sponsor prepared two study control samples. The control samples consisted of drug free urine spiked with the calibrator drugs at $50\%$ and $125\%$ of the chosen cutoffs.

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Aliquots of the control samples and samples with no drug present were adjusted to a pH of 4.0, 7.0, and 9.0. Each sample was assayed in triplicate. No negative interference due to pH was observed.

To test for possible positive and/or negative interference from specific gravity the sponsor, prepared two study control samples. The control samples consisted of drug free urine spiked with the calibrator drugs at negative and positive concentrations. Aliquots of the control samples were altered to span the specific gravity range of 1.003 to 1.030. No positive or negative interference due to specific gravity was observed.

f. Assay cut-off:

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, 1.a, above.

2. Comparison studies:

a. Method comparison with predicate device

Performance was evaluated by assaying a panel of blind coded unaltered clinical urine samples containing varying concentrations of drugs with the Profile V device. In-house results (obtained at 10 minutes) were then compared to GC/MS or LC/MS/MS results. Study results are reported in the table below.

| Drug ng/mL | Candidate Device Results | Negative | Less than half the cutoff concentration by GC/MS or LC/MS/MS | Near cutoff negative (between 50% below the cutoff and the cutoff concentration) | Near cutoff positive (between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| OXY (100) | Positive | 0 | 0 | 0 | 3 | 36 |
| | Negative | 40 | 3 | 4 | 1 | 0 |
| PPX (300) | Positive | 0 | 0 | 4 | 4 | 40 |
| | Negative | 45 | 1 | 2 | 0 | 0 |
| TCA (300) | Positive | 0 | 0 | 3 | 4 | 36 |
| | Negative | 40 | 2 | 1 | 0 | 0 |

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The summary of discordant results is listed in the table below:

| Assay | Cutoff Value (ng/mL) | Profile V Assay Pos/Neg | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- |
| OXY | 100 | Negative | Oxycodone at 71 ng/mL and Oxymorphone at 31 ng/mL. |
| PPX | 300 | Positive | Norpropoxyphene at 172 ng/mL |
| PPX | 300 | Positive | Norpropoxyphene at 194 ng/mL |
| PPX | 300 | Positive | Norpropoxyphene at 228 ng/mL |
| PPX | 300 | Positive | Norpropoxyphene at 271 ng/mL. |
| TCA | 300 | Positive | Nortriptyline at 194 ng/mL |
| TCA | 300 | Positive | Nortriptyline at 217 ng/mL |
| TCA | 300 | Positive | Desipramine at 287 ng/mL. |

b. Matrix comparison:

Not applicable. The assay is intended for only one sample matrix, urine.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable.

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

Not applicable.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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