ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE

K043507 · ACON Laboratories, Inc. · DJG · Feb 25, 2005 · Clinical Toxicology

Device Facts

• Record ID: K043507
• Device Name: ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Feb 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The ACON® OXY II One Step Oxycodone Test Strip and the ACON® OXY II One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of oxycodone in urine at a designed cut-off concentration of 100 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites. This assay 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) 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 used.

Device Story

Rapid chromatographic immunoassay for qualitative detection of oxycodone in urine. Principle: competitive binding; drug in urine competes with drug conjugate for antibody binding sites. If oxycodone < 100 ng/mL, antibody-coated particles bind to immobilized conjugate, forming a visible line (negative result). If oxycodone ≥ 100 ng/mL, binding sites are saturated, preventing line formation (positive result). Procedural control line confirms proper wicking. Used at point-of-care sites by healthcare professionals. Output is visual; requires professional judgment and confirmatory testing (GC/MS) for clinical decision-making.

Clinical Evidence

Clinical evaluation of 300 urine specimens compared subject devices against a predicate device and GC/MS. Results: 98% overall agreement with predicate; 98.67% total agreement with GC/MS. Point-of-care (POL) study at three sites showed 97% (262/270) correct interpretation by non-lab personnel, comparable to trained technicians (97%).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; mouse monoclonal antibody; visual qualitative readout; no instrumentation required; manual operation.

Indications for Use

Indicated for healthcare professionals, including point-of-care sites, for the qualitative detection of oxycodone in human urine at a 100 ng/mL cut-off. Provides preliminary results only; requires confirmation via GC/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).

Submission Summary (Full Text)

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

A. 510(k) Number:
k043507

B. Purpose of the Submission:
New 510(k)

C. Analyte:
Oxycodone

D. Type of Test:
Qualitative immunoassay

E. Applicant:
ACON Laboratories, Inc.

F. Proprietary and Established Names:
ACON OXY II One Step Oxycodone Test Strip
ACON OXY II One Step Oxycodone Test Device

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

H. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
The ACON® OXY II One Step Oxycodone Test Strip and the ACON® OXY II One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of oxycodone in urine at a designed cut-off concentration of 100 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed

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analytical result. Gas chromatography/mass spectrometry (GC/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 used.

3. Special condition for use statement(s):
The assay 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) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The assay was evaluated in point-of-care settings.

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

I. Device Description:
The ACON® OXY II One Step Oxycodone Test Strip and the ACON® OXY II One Step Oxycodone Test Device are immunoassays based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action.

Oxycodone, if present in the urine specimen below 100 ng/mL, will not saturate the binding sites of antibody in the test device. The antibody coated particles will then be captured by immobilized Oxycodone conjugate and a visible colored line will appear in the test line region. The colored line will not form in the test line region if the Oxycodone level exceeds 100 ng/mL because it will saturate all the binding sites of anti-Oxycodone antibody.

A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region.

To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

J. Substantial Equivalence Information:
1. Predicate device name(s):
ACON® OXY One Step Oxycodone Test Strip
ACON® OXY One Step Oxycodone Test Device
2. Predicate K number(s):
K033047
3. Comparison with predicate:

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The devices and their predicates are for the qualitative determination of the same analyte in the same matrix, and utilize the same cutoff concentrations. All are visually-read single use devices. The major difference is that the new devices, ACON OXY II One Step Oxycodone Test Strip and ACON OXY II One Step Oxycodone Test Device, use a new antibody-antigen system.

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

The sponsor did not identify any in the submission

## L. Test Principle:

Lateral flow immunoassay

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

**OXY II One Step Oxycodone Test Device**

A study was conducted at three independent physician's office sites by three independent, untrained, healthcare professionals using three different lots of product and run in three consecutive days to demonstrate the within-run, between-run and between-operator precision. An identical panel of coded specimens containing no oxycodone, oxycodone spiked at levels +/- 25% of the assay cut-off and oxycodone spiked at levels +/-50% of the 100 ng/mL assay cut-off were provided to each site. The results are given below:

| Oxycodone concentration (ng/mL) | n | Site A | | Site B | | Site C | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | - | + | - | + | - | + |
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 50 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 75 | 15 | 14 | 1 | 13 | 2 | 11 | 4 |
| 125 | 15 | 1 | 14 | 0 | 15 | 0 | 15 |
| 150 | 15 | 0 | 15 | 0 | 15 | 0 | 15 |

### OXY II One Step Oxycodone Test Strip

A study was conducted at three independent physician's office sites by three independent, untrained, healthcare professionals using three different lots of product and run in three consecutive days to demonstrate the within-run, between-run and between-operator precision. An identical panel of coded specimens containing no oxycodone, oxycodone spiked at levels +/- 25% of the assay cut-off and oxycodone spiked at levels +/-50% of the 100 ng/mL assay cut-off were provided to each site. The results are given below:

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| Oxycodone concentration (ng/mL) | n | Site A | | Site B | | Site C | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | - | + | - | + | - | + |
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 50 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 75 | 15 | 14 | 1 | 13 | 2 | 11 | 4 |
| 125 | 15 | 1 | 14 | 0 | 15 | 0 | 15 |
| 150 | 15 | 0 | 15 | 0 | 15 | 0 | 15 |

b. Linearity/assay reportable range:
Not applicable. The assay is intended for qualitative use.

c. Traceability (controls, calibrators, or method):
Procedural controls are included in the test strip and device. A red line appearing in the control region (C) is considered as an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with these kits; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. Users should follow local, state, and federal guidelines for testing QC materials.

d. Cutoff Studies:
OXY II One Step Oxycodone Test Device

A drug-free urine pool was spiked with Oxycodone at the following concentrations: 0 ng/mL, 50 ng/mL, 75 ng/mL, 100 ng/mL, 125 ng/mL, 150 ng/mL and 200 ng/mL. The result demonstrates 100% accuracy at 50% above and 25% below the cut-off concentration. The data are summarized below:

| Oxycodone Concentration (ng/mL) | Percent of Cutoff | n | Visual Result | |
| --- | --- | --- | --- | --- |
| | | | Negative | Positive |
| 0 | 0 | 30 | 30 | 0 |
| 50 | -50% | 30 | 30 | 0 |
| 75 | -25% | 30 | 30 | 0 |
| 100 | Cutoff | 30 | 21 | 9 |
| 125 | +25% | 30 | 6 | 24 |
| 150 | +50% | 30 | 0 | 30 |
| 200 | +100% | 30 | 0 | 30 |

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# OXY II One Step Oxycodone Test Strip

A drug-free urine pool was spiked with oxycodone at the following concentrations: 0 ng/mL, 50 ng/mL, 75 ng/mL, 100 ng/mL, 125 ng/mL, 150 ng/mL and 200 ng/mL. The result demonstrates 100% accuracy at 50% above and 25% below the cut-off concentration of the assay. The data are summarized below:

| Oxycodone Concentration (ng/mL) | Percent of Cutoff | n | Visual Result | |
| --- | --- | --- | --- | --- |
| | | | Negative | Positive |
| 0 | 0% | 30 | 30 | 0 |
| 50 | -50% | 30 | 30 | 0 |
| 75 | -25% | 30 | 30 | 0 |
| 100 | Cutoff | 30 | 18 | 12 |
| 125 | +25% | 30 | 6 | 24 |
| 150 | +50% | 30 | 0 | 30 |
| 200 | +100% | 30 | 0 | 30 |

## e. Analytical specificity:

The following table lists compounds that are positively detected in urine by the OXY II One Step Oxycodone Test Device at 5 minutes.

| Compound | Concentration (ng/mL) |
| --- | --- |
| Oxycodone | 100 |
| Oxymorphone | 200 |
| Hydrocodone | 6,250 |
| Naloxone | 37,500 |
| Naltrexone | 37,500 |
| Levorphanol | 50,000 |
| Hydromorphone | 50,000 |

## Effect of Urinary Specific Gravity

Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with 50 ng/mL and 150 ng/mL of Oxycodone respectively. The OXY II One Step Oxycodone Test Device was tested in duplicate using the fifteen neat and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.

## Effect of Urinary pH

The pH of an aliquot negative urine pool was adjusted to a pH range of 4 to 9 in 1 pH unit increments and spiked with Benzoylecgonine to 50 ng/mL and 150 ng/mL. The spiked, pH-adjusted urine was tested with the OXY II One Step Oxycodone Test Device in duplicate and interpreted according to the package insert. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.

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# Cross-Reactivity

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-negative urine or Oxycodone positive urine. The following compounds show no interference when tested with the OXY II One Step Oxycodone Test Device at a concentration of $100~\mu \mathrm{g / mL}$ .

# Non Cross-Reacting Compounds

| 4-Acetaminophenol | Acetone | Acetophenetidin |
| --- | --- | --- |
| N-Acetylprocainamide | Acetylsalicylic acid | Albumin |
| 6-Acetylcodeine | Amikacin | Albuterol |
| Amantadine | Amoxapine | Amitriptyline |
| Amobarbital | Ampicillin | Amoxicillin |
| d/l-Amphetamine | Apomorphine | Ascorbic acid |
| Aminopyrine | Atropine | Aspartame |
| Atenolol | Benzoic acid | Baclofen |
| Benzilic acid | Bilirubin | Benzoylecgonine |
| Benzphetamine | Buspirone | Brompheniramine |
| Buprenorphine | Cannabinol | Caffeine |
| Cannabidiol | Cimetidine | Carisoprodol |
| Cephalexin | Chlordiazepoxide | Chloral hydrate |
| Chloramphenicol | (+) - Chlorpheniramine | Chloroquine |
| Chlorothiazide | Chlorprothixene | (+/-) - Chlorpheniramine |
| Chlorpromazine | Clindamycin | Cholopropamide |
| Cholesterol | Clozapine | Clomipramine |
| Clonidine | Cortisone | Cocaine |
| Codeine | Cyclobarbital | (-) Cotinine |
| Creatinine | (-)Deoxyephedrine | Cyclobenzaprine |
| Deoxycorticosterone | Dextromethorphan | R (-) Deprenyl |
| Dexamethasone | Diflunisal | Diazepam |
| Dicumarol | Dihydrocodeine | Diclofenac |
| Digoxin | 4-Dimethylaminoantipyrine | Digitoxin |
| Dicyclomine | (+)-cis-Diltiazem | Diphenhydramine |
| 5,5-Diphenylhydantoin | Disopyramide | Dimenhydrinate |
| Droperidol | Ecgonine | Doxylamine |
| EDDP | EMDP | Ecgonine Methylester |
| l-Ephedrine | Efavirenz | Emetine dihydrochloride |
| l-Epinephrine | (-) -9'-Ephedrine | Ephedrine |
| β-Estradiol | (+/-) - Epinephrine | [1R,2S] (-) Ephedrine |
| Ethyl-p-aminobenzoate | Estrone-3-sulfate | Erythromycin |
| Fenfluramine | Etodolac | Ethanol |
| Fluoxetine | Fenoprofen | Ethylmorphine |
| Gentisic acid | Furosemide | Famprofazone |
| Fentanyl | d-Glucose | Gentamicin |
| Hydralazine | Haloperidol | Guaiacol Glyceryl Ether |
| Hydrocortisone | Hydrochlorothiazide | Hemoglobin |
| p-Hydroxyamphetamine | p-Hydroxymethamphetamine | o-Hydroxyhippuric acid |
| Hydroxyzine | p-Hydroxynorephedrine | 3-Hydroxytyramine (Dopamine) |
| Indomethacin | Ibuprofen | Imipramine |
| (-) Isoproterenol | Insulin | Iproniazide |
| Ketamine | Isoxsuprine | Kanamycin |
| Lithium Carbonate | Ketoprofen | Labetalol |
| Meperidine | Lidocaine | Lindane |
| Methaqualone | Loperamide | Maprotiline |
| Methoxyphenamine | Meprobamate | d/l-Methamphetamine |
| Methylphenidate | l-Methamphetamine | Metoclopramide |
| Morphine-3-β-D glucuronide | Methadone | MDMA** |
| Metronidazole | MDA* | Metoprolol |
| Nalidixic acid | Mephentermine | Methyprylon |
| α-Naphthaleneacetic acid | Morphine Sulfate | 6-Monoacetylmorphine |
| Nifedipine | Naproxen | Nalorphine. |
| Nimesulide | Norcodeine | Niacinamide |
| Norfluoxetine | Norethindrone | Niacinamide |
| Orphenadrine | Noscapine | Normorphine |
| Oxalic acid | d-Norpropoxyphene | d/l-Octopamine |
| Papaverine | Oxymetazoline | Oxolinic Acid |
| Pentazocine | Pemoline | Oxazepam |
| Phencyclidine | Pentobarbital | Penicillin-G |

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| Phenobarbital | Phenelzine | Perphenazine |
| --- | --- | --- |
| l-Phenylephrine | Phenothiazine | Pheniramine |
| Prednisolone | β-Phenylethylamine | Phentermine |
| Procyclidine | Prednisone | (+/-) Phenylpropanolamine |
| d-Propoxyphene | Promazine | Procaine |
| d-Pseudoephedrine | d/l-Propranolol | Promethazine |
| Quinine | Quinacrine | Protriptyline |
| Salbutamol | Ranitidine | Quinidine |
| Serotonin | Salicylic acid | Riboflavin |
| Sulfamethazine | Sulfisoxazole | Secobarbital |
| Sulfamethoxazole | Sulindac | Spironolactone |
| Sodium chloride | Tetrahydrozoline | Temazepam |
| Tetracycline | Thiamine | Tetrahydrocortexolone |
| Tetrahydrocortisone,3-acetate | l-Thyroxine | Thebaine |
| Theophylline | Cis-Tramadol | Thioridazine |
| Thiothixene | Trimethobenzamide | Tobramycin |
| Tolbutamide | Trifluoperazine | Trans-2-phenylcyclopropylamine |
| Trazodone | d/l-Tryptophan | Triamterene |
| Trimipramine | Tyramine | Trimethoprim |
| Tryptamine | Vancomycin | Vancomycin |
| d/l-Tyroxine | Uric Acid | Zopiclone |
| Verapamil | Zomepirac | |
| *MDA: 3,4-Methylenedioxyamphetamine | | |
| **MDMA: 3,4-Methylenedioxymethamphetamine | | |

f. Assay cut-off:

The ACON® OXYII One Step Oxycodone Test Strip/ ACON® OXYII One Step Oxycodone Test Device yields a positive result when the oxycodone level in urine exceeds 100 ng/mL. At present, the Substance Abuse and Mental Health Services Administration (SAMHSA) does not have a recommended screening cutoff for oxycodone positive specimens.

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the detection limit section, above.

2. Comparison studies:

a. Method comparison with predicate device:

OXY II One Step Oxycodone Test Device

300 urine samples were obtained and tested with the OXYCODONE II One Step Oxycodone II Test Device and by GC/MS the results are summarized below:

| Specimen Cutoff Range by GC/MS | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Negative* | <-25% cutoff | -25% to cutoff | Cutoff to +25% | >+25% cutoff | % Agreement |
| ACON OXY II Test Device | Positive | 0 | 0 | 1 | 2 | 133 | 99% (135/136) |
| | Negative | 147 | 6 | 8 | 0 | 3 | 98% (161/164) (95%-99%)** |

Total agreement with GC/MS: 296/300=99% (97%-99%)**

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**Denotes 95% confidence interval
*Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of 5.

# OXY II One Step Oxycodone Test Strip

300 urine samples were obtained and tested with the OXY II One Step Oxycodone Test Strip and by GC/MS the results are summarized below:

| Specimen Cutoff Range by GC/MS | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Negative* | < -25% utoff | -25% to cutoff | Cutoff to +25% | >+25% cutoff | % Agreement |
| ACON OXY II Test Strip | Positive | 0 | 0 | 1 | 2 | 133 | 99% (135/136) |
| | Negative | 147 | 6 | 8 | 0 | 3 | 98% (161/164) (95%-99%)** |

Total agreement with GC/MS: 296/300=99% (97%-99%)**
**Denotes 95% confidence interval
*Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of 5.

# b. Matrix comparison:

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

# 3. Clinical studies:

a. Clinical sensitivity:

Not applicable. Clinical studies are not typically submitted for this device type.

b. Clinical specificity:

Not applicable. Clinical studies are not typically submitted for this device type.

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. Conclusion:

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