QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121

K043051 · Phamatech, Inc. · DJG · Feb 7, 2005 · Clinical Toxicology

Device Facts

• Record ID: K043051
• Device Name: QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
• Applicant: Phamatech, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of the oxycodone in urine. The cutoff concentration for this test is 100 ng/ml. This assay is intended for professional use. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

Device Story

QuickScreen™ Oxycodone Test is a rapid, qualitative, one-step lateral flow immunoassay for urine drug screening. Device utilizes visual color sandwich immunochemical technology to detect oxycodone presence at 100 ng/mL cutoff. Intended for professional use in clinical settings. Operator performs test by applying urine sample to device; results are interpreted visually by the clinician. Output is a preliminary qualitative result (positive/negative). Preliminary positive results require secondary confirmation via GC/MS or alternative chemical methods. Device assists healthcare providers in identifying potential oxycodone use, facilitating clinical decision-making regarding patient management.

Clinical Evidence

Clinical evidence includes a clinical sample correlation study and a blind labeled spiked study. Results demonstrated >99% correlation with predicate devices. No further clinical performance metrics (sensitivity/specificity) provided beyond correlation data.

Technological Characteristics

Lateral flow immunoassay; visual color sandwich technology; immunochemical principle (antibody/target analyte/antibody complex formation). Standalone, single-use test device. No electronic components, software, or external energy source required.

Indications for Use

Indicated for the qualitative detection of oxycodone in human urine at a cutoff concentration of 100 ng/mL. Intended for professional use as a preliminary screening test. Requires confirmatory testing via GC/MS or other chemical methods.

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

• American BioMedica Corporation RapidOne OXY Test (k014101)

Submission Summary (Full Text)

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

A. 510(k) Number:
k043051

B. Purpose for Submission:
New submission

C. Measurand:
Oxycodone

D. Type of Test:
Lateral Flow Immunoassay Methodology

E. Applicant:
Pharmatech, Inc.

F. Proprietary and Established Names:
QuickScreen Oxycodone Test Model 9120 Strip, 9120T Dip Card, 9120X Cup, and 9121 Cassette.

G. Regulatory Information:
1. Regulation section:
862.3650, Enzyme Immunoassay, Opiates
2. Classification:
Class II
3. Product code:
DJG
4. Panel:
91 (Toxicology)

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H. Intended Use:

1. Intended use(s):
The QuickScreen Oxycodone Test is a rapid qualitative immunoassay for the detection of Oxycodone in human urine. The cutoff concentration for this test is 100 ng/mL. This test is intended for professional use only.

2. Indication(s) for use:
The QuickScreen Oxycodone Test is an in-vitro diagnostic screen for the detection of oxycodone in urine. This kit provides a preliminary result for the detection/presence of oxycodone in urine. It is intended for professional use only.

3. Special conditions for use statement(s):
The QuickScreen Oxycodone Test provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/Mass spectrometry is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

4. Special instrument requirements:
Not applicable. The device is a visually read single-use device.

I. Device Description:
The product #9120 is a single-use dip-strip device. The operators dip the test strip into the urine and the reaction is initiated by movement of the sample through the test strip.

The product #9120T is a single-use Dip Card device in a cassette format. The operator inserts the absorbent end of the device in the urine sample to the maximum level indicated by the line on the device label. The test reaction is initiated by movement of the sample through the test strip.

The product #9120X is a single-use device utilizing a cup format. The donor collects urine in the cup to the recommended volume. The reaction is initiated by movement of the sample through the test strip. Test strips are incorporated into the sides of a sample cup.

The product #9121 is a single-use Cassette Version device. The operator lays the cassette on a level surface and adds 4 drops of urine to the Sample Well with the provided sample pipette. The reaction is initiated by movement of the sample through the test strip.

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J. Substantial Equivalence Information:

1. Predicate device name(s):
American BioMedica Corporation RapidOne OXY Test

2. Predicate 510(k) number(s):
k014101

3. Comparison with predicate:
Both devices are for the qualitative determination of the same analyte(s) in the same matrix, and utilize the same cutoff concentration. Both are visually-read single use devices.

| | ABMC
Oxycodone
Test | QuickScreen
Oxycodone
Test Model
9120 | QuickScreen
Oxycodone
Test Model
9120T | QuickScreen
Oxycodone
Test Model
9120X | QuickScreen
Oxycodone
Test Model
9121 |
| --- | --- | --- | --- | --- | --- |
| Format | Dip Card | Dip Strip | Dip Card | Cassette | Cup Version |
| In Vitro
Diagnostic
Use | Yes | Yes | Yes | Yes | Yes |
| Intended Use | Detection of
Oxycodone
or
Oxycodone
Metabolites
in Urine | Detection of
Oxycodone
or
Oxycodone
Metabolites
in Urine | Detection of
Oxycodone
or
Oxycodone
Metabolites
in Urine | Detection of
Oxycodone
or
Oxycodone
Metabolites
in Urine | Detection of
Oxycodone
or
Oxycodone
Metabolites
in Urine |
| Specimen | Urine | Urine | Urine | Urine | Urine |
| Methodology | Lateral Flow
Immunoassay | Lateral Flow
Immunoassay | Lateral Flow
Immunoassay | Lateral Flow
Immunoassay | Lateral Flow
Immunoassay |
| Qualitative | Yes | Yes | Yes | Yes | Yes |
| Antibodies | Monoclonal
Polyclonal | Monoclonal
Polyclonal | Monoclonal
Polyclonal | Monoclonal
Polyclonal | Monoclonal
Polyclonal |
| Analyte | Oxycodone | Oxycodone | Oxycodone | Oxycodone | Oxycodone |
| Cutoff | 100 ng/mL | 100 ng/mL | 100 ng/mL | 100 ng/mL | 100 ng/mL |
| Control
Feature | Procedural
Control Line | Procedural
Control Line | Procedural
Control Line | Procedural
Control Line | Procedural
Control Line |
| End User | Health Care
Professional | Health Care
Professional | Health Care
Professional | Health Care
Professional | Health Care
Professional |

K. Standard/Guidance Document Referenced (if applicable):
None referenced.

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L. Test Principle:

The QuickScreen™ Oxycodone Test is a competitive immunoassay that is used to screen for the presence of Oxycodone and its metabolites in urine. It is a chromatographic absorbent device in which drugs or drug metabolites in the sample compete with drug/protein conjugate on a porous membrane for a limited number of antibody/ dye conjugate binding sites. The test device employs a unique combination of monoclonal and polyclonal antibodies to selectively identify Oxycodone and its metabolites.

In the procedure, the absorbent end of the device is inserted in the urine sample. Urine is absorbed into the device by capillary action, mixes with the antibody/ dye conjugate and flows across the pre-coated membrane. When sample Oxycodone levels are below 100 ng/mL (the detection sensitivity of the test) antibody/ dye conjugate binds to the drug / protein conjugate immobilized in the Test Region (T) of the device. This produces a colored Test Band that regardless of its intensity indicates a negative result.

When sample Oxycodone levels are at or above 100 ng/mL, the free drug in the sample binds to the antibody/ dye conjugate, preventing the antibody/ dye conjugate from binding to the drug/ protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band, indicating a potentially positive sample.

In either case, a colored Control Band is produced in the Control Region (C) by a non-specific antibody-dye/ conjugate reaction. This band serves as a built in quality control device, demonstrating migration of the urine sample across the membrane as well as confirming that the test is complete.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

To determine the precision of the QuickScreen™ Oxycodone Test within and between assays, eight separate normal urine pools were spiked with Oxycodone metabolites as follows:

| | Concentration (ng/mL) |
| --- | --- |
| <1% to 25% of cutoff | 20 |
| 26% to 50% of cutoff | 31 |
| 51% to 75% of cutoff | 62 |
| 76% to cutoff | 77 |
| Cutoff to 125% of cutoff | 105 |
| 126% to 150% of cutoff | 152 |
| 151% to 175% of cutoff | 173 |
| 176% to 200% of cutoff | 199 |

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One replicate of each level was assayed twice a day for twenty days, in accordance with package insert instructions using two lots of the QuickScreen Oxycodone Test. The interpretations of either negative or positive result was recorded in each case and used to evaluate precision. The results of this evaluation are listed in the table below.

Percent Correct

| | Test 1 | Test 2 | Overall | Percent Correct |
| --- | --- | --- | --- | --- |
| Day | 8/8 | 8/8 | 16/16 | 100% |
| 1 | 8/8 | 8/8 | 16/16 | 100% |
| 2 | 8/8 | 8/8 | 16/16 | 100% |
| 3 | 8/8 | 8/8 | 16/16 | 100% |
| 4 | 8/8 | 8/8 | 16/16 | 100% |
| 5 | 8/8 | 8/8 | 16/16 | 100% |
| 6 | 8/8 | 8/8 | 16/16 | 100% |
| 7 | 8/8 | 8/8 | 16/16 | 100% |
| 8 | 8/8 | 8/8 | 16/16 | 100% |
| 9 | 8/8 | 8/8 | 16/16 | 100% |
| 10 | 8/8 | 8/8 | 16/16 | 100% |
| 11 | 8/8 | 8/8 | 16/16 | 100% |
| 12 | 8/8 | 8/8 | 16/16 | 100% |
| 13 | 8/8 | 8/8 | 16/16 | 100% |
| 14 | 8/8 | 8/8 | 16/16 | 100% |
| 15 | 8/8 | 8/8 | 16/16 | 100% |
| 16 | 8/8 | 8/8 | 16/16 | 100% |
| 17 | 8/8 | 8/8 | 16/16 | 100% |
| 8 | 8/8 | 8/8 | 16/16 | 100% |
| 19 | 8/8 | 8/8 | 16/16 | 100% |
| 20 | 8/8 | 8/8 | 16/16 | 100% |

b. Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

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

There are no controls or calibrators provided with or specifically identified for use in the package insert.

STABILITY

The sponsor specifies the method used to analyze the material, environmental storage conditions, frequency of testing, baseline against which measurements are compared, and acceptance criteria for the study. Accelerated studies are being used by the sponsor to estimate the expiration date, however, on-going real time

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studies are being performed.

# d. Detection limit:

Sensitivity of this assay is characterized by validating performance around the claimed cutoff concentration of the assay, including a determination of the lowest concentration of drug that is capable of producing a positive result.

QuickScreen™ and ABMC RapidOne Oxy compared to GC/MS Method Correlation around Cut-off

QuickScreen 18 22

RapidOne Oxy 18 22

GCMS 18 22

Sample range across assay range: quantification by GC/MS

| ng/mL | 75-80 | 81-85 | 86-90 | 91-95 | 96-100 | 101-105 | 106-110 | 111-115 | 116-125 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample n | 8 | 4 | 1 | 6 | 4 | 3 | 3 | 4 | 7 |
| Pharmatech | 8 neg | 4 neg | 1 neg | 6 neg | 3 neg 1 pos | 3 pos | 3 pos | 4 pos | 7 pos |
| ABMC | 8 neg | 4 neg | 1 neg | 6 neg | 3 neg 1 pos | 3 pos | 3 pos | 4 pos | 7 pos |

All results indicating a positive sample were confirmed by GC/MS testing. All samples which were confirmed to be Oxycodone positive were confirmed to be positive at a level $&gt;100\mathrm{ng / mL}$ .

# e. Analytical specificity:

Specificity studies included testing of cross-reacting metabolites, potential exogenous interferents and potential endogenous interferents. Each chemical or biological analyte was spiked into aliquots of a normal urine pool. The pools were tested for possible interference in the assay in accordance with the package insert procedure. The chemical/agent and the concentration (in $\mu \mathrm{g} / \mathrm{mL}$ ) at which tested is recorded. Any chemical/agent producing a result equivalent to the cutoff (i.e.: positive) is noted in the following table. No compound tested at the level indicated exhibited any sign of interference in the test.

| Chemical Analytes | μg/mL | Test Result | Chemical Analysis | μg/mL | Test Result |
| --- | --- | --- | --- | --- | --- |
| Acetone | 10,000 | Neg | Mephentermine | 100 | Neg |
| 4-Aceamidophenol | 1,000 | Neg | Meprobamate | 100 | Neg |
| 6-Acetylmorphine | 100 | Neg | Mescaline | 100 | Neg |
| 6-Acetylcodeine | 100 | Neg | Metanephrine DL | 100 | Neg |
| Albumin | 100 | Neg | (±) Methadone | 100 | Neg |

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| Chemical Analytes | μg/mL | Test Result | Chemical Analysis | μg/mL | Test Result |
| --- | --- | --- | --- | --- | --- |
| Acetylsalicylic Acid | 2,000 | Neg | (+) Methamphetamine | 100 | Neg |
| N-Acetylprocainamide | 100 | Neg | Methaqualone | 100 | Neg |
| Alphenal | 100 | Neg | (±) 3,4-Methylenedioxy-methamphetamine | 100 | Neg |
| Alprazolam | 100 | Neg | Methylphenidate | 1,000 | Neg |
| Amantadine | 100 | Neg | Methyprylon | 100 | Neg |
| (+) Amethopterin | 100 | Neg | Metoclopramide | 100 | Neg |
| Amikacin | 200 | Neg | (±) Metoprolol | 100 | Neg |
| DL-Aminoglutethimide | 100 | Neg | Morphine | 0.30 | Neg |
| Amino pyrene | 100 | Neg | Morphine 3-β-D Glucuronide | 0.30 | Neg |
| Amitriptyline | 100 | Neg | 2-Methyl-3-(3,4Dihydrophenly) DL & L Alanine | 100 | Neg |
| Amobarbital | 100 | Neg | (±) Methylenedioxy meth-amphetamine | 100 | Neg |
| Amoxicillin | 300 | Neg | 6-Methylenedioxymeth-amphetamine | 100 | Neg |
| Ampicillin | 100 | Neg | Nafcillin | 100 | Neg |
| D-Amphetamine | 100 | Neg | Nalorphine | 0.50 | Neg |
| DL-Amphetamine | 100 | | | | |
| L-Amphetamine | 100 | | | | |
| Apomorphine | 100 | Neg | Naloxone | 0.40 | Neg |
| Ascorbic Acid | 60,000 | Neg | Naltrexone | 5.00 | Neg |
| Aspartame | 100 | Neg | Naphazoline | 100 | Neg |
| Aspartic Acid D, L, & DL | 100 | Neg | α Naphthaleneacetic Acid | 100 | Neg |
| Atropine | 100 | Neg | β Naphthaleneacetic Acid | 100 | Neg |
| Barbital | 100 | Neg | Naproxen | 1,000 | Neg |
| Barbituric Acid | 100 | Neg | Netilmicin | 100 | Neg |
| Benzoic Acid | 100 | Neg | Niacinamide | 100 | Neg |
| Benzoylecgonine | 100 | Neg | Nialamide | 100 | Neg |
| Benzphetamine | 100 | Neg | Nicotinic Acid | 100 | Neg |
| Benztropine methane sulfonate | 100 | Neg | Nifedipine | 100 | Neg |
| Bilirubin | 100 | Neg | Nitrazepam | 100 | Neg |
| **Bromazepam** | 100 | Neg | Nomifensine | 100 | Neg |
| 2-Bromo-α | 100 | Neg | Norcodeine | 100 | Neg |

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| Chemical Analytes | μg/mL | Test Result | Chemical Analysis | μg/mL | Test Result |
| --- | --- | --- | --- | --- | --- |
| Ergocryptine | | | | | |
| (+)-
Brompheniramine | 100 | Neg | 11 Nor Δ^{8} THC
Carboxylic Acid | 10 | Neg |
| Butabarbital | 100 | Neg | 11 Nor Δ^{9} THC
Carboxylic Acid | 5 | Neg |
| Butalbital | 100 | Neg | NOR doxepin | 100 | Neg |
| Butethal | 100 | Neg | Norethindrone | 100 | Neg |
| Caffeine | 20,000 | Neg | Normorphine | 10 | Neg |
| Cannabidiol | 100 | Neg | Nortriptyline | 100 | Neg |
| Cannabinol | 100 | Neg | Noscapine | 200 | Neg |
| Carbamazepine | 100 | Neg | Nylidrin | 100 | Neg |
| Cephalexin | 100 | Neg | Orphenadrine | 1,000 | Neg |
| Chloramphenicol | 100 | Neg | Oxalic Acid | 1,000 | Neg |
| Chlordiazepoxide | 100 | Neg | Oxazepam | 100 | Neg |
| Chloroquine | 200 | Neg | Oxycodone | 0.45 | Neg |
| Chloropropamide | 100 | Neg | Oxymetazoline | 100 | Neg |
| (+) and (±)
Chlorpheniramine | 100 | Neg | Papaverine | 100 | Neg |
| Chlorpromazine | 100 | Neg | Penicillin G | 100 | Neg |
| Chloropropamide | 100 | Neg | Pentazocine | 100 | Neg |
| Chlorprothixene | 100 | Neg | Pentobarbital | 100 | Neg |
| Cimetidine | 100 | Neg | Phencyclidine | 100 | Neg |
| Clemastine | 100 | Neg | Phenelzine | 100 | Neg |
| Clonazepam | 100 | Neg | Pheniramine | 100 | Neg |
| Clonidine | 100 | Neg | Phenobarbital | 100 | Neg |
| Clomipramine | 100 | Neg | Phenothiazine | 100 | Neg |
| Cocaine | 100 | Neg | Phentermine | 100 | Neg |
| Codeine | 100 | Neg | Phenyl acetone | 100 | Neg |
| (-)- Cotinine | 100 | Neg | Phenylbutazone | 100 | Neg |
| Creatinine | 10,000 | Neg | trans 2 phenyl
cyclopropylamine | 100 | Neg |
| Cyclobenzaprine | 100 | Neg | L-Phenylephrine | 100 | Neg |
| Cyclizine | 100 | Neg | (R) (+) α
Phenylethylamine | 100 | Neg |
| Cyproheptadine | 100 | Neg | (±)α Phenylethylamine | 100 | Neg |
| Cyclosporin A | 100 | Neg | β Phenylethylamine | 100 | Neg |
| Cyproheptadine | 100 | Neg | (±)
phenylpropanolamine | 100 | Neg |
| Deoxyephedrine | 100 | Neg | Piroxicam | 100 | Neg |
| Desmethyldiazepam | 100 | Neg | Potassium Chloride | 500 | Neg |
| Dextromethorphan | 0.50 | Neg | Prazepam | 100 | Neg |

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| Chemical Analytes | μg/mL | Test Result | Chemical Analysis | μg/mL | Test Result |
| --- | --- | --- | --- | --- | --- |
| 5,5 Diallylbarbituric Acid | 100 | Neg | Prednisolone | 100 | Neg |
| Diazepam | 100 | Neg | Primidone | 100 | Neg |
| **Diflunisal** | 100 | Neg | Procainamide | 100 | Neg |
| Digoxin | 100 | Neg | Procaine | 100 | Neg |
| Dihydrocodeine | 100 | Neg | Prochlorperazine | 100 | Neg |
| 4-Dimethylaminoantipyrine | 100 | Neg | Promazine | 100 | Neg |
| Diphenhydramine | 100 | Neg | Promethazine | 100 | Neg |
| Diphenoxylate | 100 | Neg | (+) propoxyphene | 100 | Neg |
| Diphenylhydantoin 5,5 | 100 | Neg | 2-propylpentioic Acid | 100 | Neg |
| Disopyramide | 100 | Neg | Protriptyline | 100 | Neg |
| Doxepin | 100 | Neg | Pyrilamine | 100 | Neg |
| Doxylamine | 100 | Neg | Quinidine | 100 | Neg |
| 2 Ethylidene-1,5 Dimethyl-3,3 Diphenyl pyrrolidine | 100 | Neg | Quinine | 100 | Neg |
| Ψ Ephedrine (+)(±) and (-) | 1,000 | Neg | Ranitidine | 100 | Neg |
| Ephedrine (+) (±) and (-) | 1,000 | Neg | Riboflavin | 750 | Neg |
| Epinephrine (±) and (-) | 1,000 | Neg | (-) Scopolamine | 100 | Neg |
| Erythromycin | 100 | Neg | Secobarbital | 100 | Neg |
| Estriol | 100 | Neg | Sodium Chloride | 60,000 | Neg |
| Estrone 3 Sulfate | 100 | Neg | Sulindac | 100 | Neg |
| Ethanol | 10,000 | Neg | Temazepam | 100 | Neg |
| Ethosuximide | 100 | Neg | Terbutaline | 100 | Neg |
| Ethyl-p-Aminobenzoate | 100 | Neg | Tetracycline | 200 | Neg |
| Ethylmorphine | 0.35 | Neg | Tetraethylthiuram Disulfide | 100 | Neg |
| Fenfluramine | 100 | Neg | Δ^{8} Tetrahydrocannabinol | 100 | Neg |
| Fenoprofen | 100 | Neg | Δ^{9} Tetrahydrocannabinol | 100 | Neg |
| Fentanyl | 10 | Neg | Tetrahydrozoline | 100 | Neg |
| Flunitrazepam | 100 | Neg | Theophylline | 100 | Neg |
| Flurazepam | 100 | Neg | Thioridazine | 100 | Neg |
| Furosemide | 100 | Neg | cis- Thiothixene | 100 | Neg |
| Gentamicin | 100 | Neg | Tobramycin | 100 | Neg |

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| Chemical Analytes | μg/mL | Test Result | Chemical Analysis | μg/mL | Test Result |
| --- | --- | --- | --- | --- | --- |
| Gentisic Acid | 100 | Neg | Triamterene | 100 | Neg |
| Glucose | 60,000 | Neg | Triazolam | 100 | Neg |
| DL Glutethimide | 100 | Neg | Trifluoperazine | 200 | Neg |
| Griseofulvin | 100 | Neg | Triflupromazine | 100 | Neg |
| Guaiacol glyceryl Ester | 100 | Neg | DL Trihexyphenidyl | 100 | Neg |
| Hemoglobin, human | 100 | Neg | Trimethobenzamide | 100 | Neg |
| Heroin | 100 | Neg | Trimethoprim | 100 | Neg |
| Hexobarbital | 100 | Neg | Trimipramine | 300 | Neg |
| Hydrochlorothiazide | 100 | Neg | Triprolidine | 100 | Neg |
| Hydrocodone | 0.40 | Neg | Tyramine | 100 | Neg |
| 5 Hydroxyindol-3 Acetic Acid | 100 | Neg | Urea | 60,000 | Neg |
| o Hydroxy hippuric Acid | 2,000 | Neg | Uric Acid | 100 | Neg |
| 5 Hydroxyindole-2 Carboxylic Acid | 100 | Neg | Vancomycin | 100 | Neg |
| 11 Hydroxy9 THC | 5 | Neg | (±) Verapamil | 1,000 | Neg |
| 3 Hydroxytyramine | 100 | Neg | Zomepirac | 100 | Neg |
| Levorphanol | 0.5 | Neg | | | |
| Lidocaine | 100 | Neg | | | |
| Lithium Carbonate | 100 | Neg | | | |
| (±) Lorazepam | 100 | Neg | | | |
| Lormetazepam | 100 | Neg | | | |
| Lysergic Acid Diethylamide | 2.5 | Neg | | | |
| Medazepam | 100 | Neg | | | |
| Melanin | 100 | Neg | | | |
| Meperidine | 100 | Neg | | | |

Interference and cross reactivity studies were performed by testing the drug analytes in the QuickScreen™ Oxycodone Test with other biological compounds found in urine as well as various chemical agents. Below is a list of drugs which yield a positive result at or above the concentration (ng/mL) stated:

| Analyte | Concentration (ng/mL) |
| --- | --- |
| Hydrocodone | 25,000 ng/mL |
| Hydromorphone | 50,000 ng/mL |
| Norcodeine | 100,000 ng/mL |
| Oxycodone | 100 ng/mL |
| Oxymorphone | 100 ng/mL |

a. Assay cut-off:

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The assay cutoff was determined using spiked urine samples in a controlled study. The assay cutoff for the Pharmatech, Inc. QuickScreen™ Oxycodone Test is 100 ng/mL.

## 2. Comparison studies:

### a. Method comparison with predicate device:

To compare the accuracy of the QuickScreen™ Oxycodone Test to detect the presence or absence of Oxycodone in urine samples to results obtained with the American Biomedical RapidOne Oxy Test (ABMC) (k014101) predicate device. A total of one hundred and ninety two (192) samples obtained from clinical sites were used. All sample collection was performed at these clinical sites. Testing was performed at Pharmatech. Immediately upon completion of the assays, results were visually scored as “negative” (absence of Oxycodone metabolites in concentrations of 100 ng/mL or greater) or “positive” (presence of Oxycodone or Oxycodone metabolites in concentrations of 100 ng/mL or greater) by the technician. Quality assurance personnel then verified all results. After all in-house testing was completed the samples were analyzed by gas chromatography / mass spectrometry. Test results were recorded in the equivalency summary protocol by QC personnel.

## Results

Of the 192 urine samples collected 192 were tested. The performance characteristics of the QuickScreen™ Oxycodone Test to the ABMC RapidOne assay are presented in the table below.

QuickScreen™ versus ABMC Uncorrected Clinical Correlation

| | Positive | Negative |
| --- | --- | --- |
| QuickScreen | 98 | 94 |
| RapidOne Oxy | 98 | 94 |
| Sensitivity | 98/98 | = 100% |
| Specificity | 94/94 | = 100% |
| Accuracy | 192/192 | = 100% |

ABMC

| QuickScreen | | + | - |
| --- | --- | --- | --- |
| | + | 98 | 0 |
| | - | 0 | 94 |

As presented in the above chart one hundred ninety two (192) urine samples evaluated in the ABMC – QuickScreen comparison study, ninety eight (98) were positive and ninety four (94) were negative by the ABMC RapidOne Oxy test. The QuickScreen test identified 98 positive and 94 negative samples.

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Lastly, the performance characteristics of the QuickScreen™ Oxycodone Test, ABMC RapidOne Oxy Test are compared to the GC/MS method presented in the table below.

QuickScreen™ and ABMC RapidOne Oxy compared to GC/MS Method Combined Correlation

| QuickScreen | 80 | 72 |
| --- | --- | --- |
| RapidOne Oxy | 80 | 72 |
| GC/MS | 80 | 72 |

Sample range across assay range: quantification by GC/MS

| Ng/mL | 0-100 | 101-200 | 201-300 | 301-400 | 401-500 | 501-800 | 801-1000 | 1001-2000 | >2000 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | | |
| Sample n = | 72 | 16 | 13 | 8 | 7 | 8 | 11 | 10 | 7 |

All results indicating a positive sample were confirmed by GC/MS testing. All samples which were confirmed to be Oxycodone positive were confirmed to be positive at a level &gt;100 ng/mL

Overall the QuickScreen™ Oxycodone Test obtained an accuracy of 100% when compared to the ABMC predicate device. The QuickScreen™ test correctly detected 100% of the positive samples and 100% of the negative samples.

b. Matrix Comparison

Not applicable since this test is for Oxycodone in Urine samples only.

3. Clinical studies:

a. Clinical sensitivity:

Clinical studies are not typically submitted for this device type.

b. Clinical specificity:

Clinical studies are not typically submitted for this device type.

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

Not applicable

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4. Clinical cut-off:
Not applicable for this device type.

5. Expected values/Reference range:
Not applicable for this device type.

N. Conclusion:
The submitted material in this premarket notification is complete and supports a substantial equivalence decision.

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