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

Intended 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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# FEB 2 5 2005

#### 8. 510(k) SUMMARY

This summary of 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 K043507

# Submitter:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: [phone] Fax: [phone]

# Date:

December 17, 2004

# Contact Person:

Edward Tung, Ph.D.

### Product Names:

ACON® OXY II One Step Oxycodone Test Strip ACON® OXY II One Step Oxycodone Test Device

# Common Name:

Immunochromatographic test for the qualitative detection of Oxycodone in urine.

# Regulation Name:

Oxycodone test system.

## Product Code:

DJG

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# Classification Number:

21 CFR, 862.3650

# Device Classification:

The Oxycodone test systems have been classified as Class II devices with moderate complexity. The ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are similar to another FDA-cleared device for the qualitative detection of Oxycodone in urine specimens. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis.

# Intended Use:

The ACON OXY II One Step Oxycodone Test Strip and ACON OXY II One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone in urine at a cutoff concentration of 100 ng/mL. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method. preferably GC/MS analysis. They are intended for healthcare professionals including professionals at point-of-care sites.

# Description:

The ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Oxycodone in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Oxycodone and its metabolite in urine at a cutoff concentration of 100 ng/mL. These tests can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region. while a negative urine specimen or a urine specimen containing Oxycodone at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a coloredline should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

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### Comparison to a Predicate Device:

A comparison of the features of the ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device versus a FDA-cleared Oxycodone test with 100 ng/mL Oxycodone cutoff is shown below:

- . Both tests are assays intended for the qualitative detection of Oxycodone in urine samples.
- . Both tests are intended as a screening method that provides a preliminary analytical test result.
- Both tests are immunochromatographic, lateral flow assays for the rapid detection of Oxycodone with a visual, qualitative end result.
- Both tests utilize the same basic immunoassay principles that rely on antigen/ antibody interactions to indicate a positive or negative result.
- . Both tests have a cutoff Oxycodone concentration of 100 ng/mL.

#### Safety and Effectiveness Data:

#### Accuracy

A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Oxycodone concentration fell between -- 25% cutoff to +25% cutoff range. This evaluation compared the test results between the ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device with a FDA-cleared Oxycodone test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. These comparisons of data yielded the following results:

# ACON OXY II One Step Oxycodone Test Strip versus a FDA-cleared OXY Test:

Positive Agreement: 135 / 140 = 96% (92% - 99%)* Negative Agreement: 159 / 160 = 99% (97% - 99%)* Overall Agreement: 294 / 300 = 98% (96% - 99%)* * 95% confidence intervals

# ACON OXY II One Step Oxycodone Test Device versus a FDA-cleared OXY Test:

Positive Agreement: 135 / 140 = 96% (92% - 99%)* Negative Agreement: 159 / 160 = 99% (97% - 99%)* Overall Agreement: 294 / 300 = 98% (96 % - 99%)* 95% confidence intervals *

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# ACON OXY II One Step Oxycodone Test Strip versus data obtained with GC/MS at the cutoff concentration of 100 ng/mL:

| ACON OXY II One Step Oxycodone Test Strip versus GC/MS. | | |
|---------------------------------------------------------|--|--|
|---------------------------------------------------------|--|--|

| | Test<br>Result | Specimen Cutoff Range by GC/MS Data | | | | | |
|---------------------------------|----------------|-------------------------------------|------------------|-------------------|-------------------|------------------|-------------------------------|
| | | Negative† | < -25%<br>Cutoff | -25% to<br>Cutoff | Cutoff to<br>+25% | > +25%<br>Cutoff | % Agreement |
| ACON<br>OXY II<br>Test<br>Strip | Positive | 0 | 0 | 1 | 2 | 133 | 99% (135/136)<br>(96% - 99%)* |
| | Negative | 147 | 6 | 8 | 0 | 3 | 98% (161/164)<br>(95% - 99%)* |

Total agreement with GC/MS: 296/300 = 98.67% (97%- 99%)*

* Denotes 95% confidence interval.

* Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of 5.

# ACON OXY II One Step Oxycodone Test Device versus GC/MS.

| | Test<br>Result | Specimen Cutoff Range by GC/MS Data | | | | | |
|----------------------------------|----------------|-------------------------------------|------------------|-------------------|-------------------|------------------|-------------------------------|
| | | Negative+ | < -25%<br>Cutoff | -25% to<br>Cutoff | Cutoff to<br>+25% | > +25%<br>Cutoff | % Agreement |
| ACON<br>OXY II<br>Test<br>Device | Positive | 0 | 0 | 1 | 2 | 133 | 99% (135/136)<br>(96% - 99%)* |
| | Negative | 147 | 6 | 8 | 0 | 3 | 98% (161/164)<br>(95% - 99%)* |

Total agreement with GC/MS: 296/300 = 98.67% (97%- 99%)*

* Denotes 95% confidence interval.

* Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of vi

# Performance Characteristics and Other information:

The performance characteristics of the ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device were verified by analytical sensitivity study, specificity and cross reactivity study, interference studies, precision study, read time flex study, temperature flex study, specimen storage and stability study. Study results indicate that these test devices are robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in their package inserts.

# POL Study Summary:

:

Test results obtained from three POL study sites indicated that personnel at different doctor's offices with various educational background and working experience could perform the ACON® OXY II One Step Oxycodone tests properly and interpret test results correctly in most cases (97%, 262/270). The POL study results are also comparable to those obtained from a trained lab technician (97%, 87/90).

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# Conclusion:

These clinical studies demonstrated substantial equivalency on performance among the ACON OXY II One Step Oxycodone Test Strip, the ACON OXY II One Step Oxycodone Test Device and a FDA-cleared Oxycodone test with the same Oxycodone cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Oxycodone at a concentration of 100 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines above it.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 5 2005

Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd San Diego, CA 92121

Re: k043507 Trade/Device Name: ACON OXY II One Step Oxycodone Test Strip ACON OXY II One Step Oxycodone Test Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: December 17, 2004 Received: December 20, 2004

Dear Dr. Tung:

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 dcvices 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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# Page 2 --

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

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Coogen, MS, DUM

Jean M. Cooper, MS, D.V.M. 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 11.

510(k) Number (if known): K043507

ACON OXY II One Step Oxycodone Test Strip Device Name:

ACON OXY II One Step Oxycodone Test Device

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 levels in urine at a designated cutoff 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.

Prescription Use X (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)

Division Sign-Off
acting

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K043507

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