ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE

K040274 · ACON Laboratories, Inc. · DJG · May 3, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040274
• Device Name: ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: May 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The ACON® OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device are rapid chromatographic immunoassays for the qualitative detection of Opiate in urine at a cutoff concentration of 2,000 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.

Device Story

Lateral flow, competitive binding immunochromatographic assay; detects opiates in urine. Principle: mouse monoclonal antibody-antigen interaction. Input: urine sample; Output: visual colored line on test strip/device. No instrumentation required. Used at point-of-care sites by healthcare professionals. Positive result: absence of colored line in test region; Negative result: presence of colored line. Procedural control line confirms proper sample volume and wicking. Preliminary screening only; requires GC/MS confirmation. Assists clinicians in identifying potential opiate presence to guide further diagnostic or clinical decision-making.

Clinical Evidence

Clinical evaluation of 300 urine specimens compared ACON OPI II devices against an FDA-cleared predicate and GC/MS. Overall agreement with predicate was >99% (95% CI: 98%-99%). Agreement with GC/MS at 2,000 ng/mL cutoff showed 98% positive agreement and 97% negative agreement. Study included specimens with concentrations ranging from -25% to +25% of the cutoff. Additional bench testing verified analytical sensitivity, specificity, cross-reactivity, interference, precision, and environmental robustness.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding format. Utilizes mouse monoclonal antibodies. Qualitative visual readout. No external energy source or instrumentation required. Standalone test strip or cassette device. Sterilization not specified.

Indications for Use

Indicated for the qualitative detection of opiates in human urine at a 2,000 ng/mL cutoff. Intended for use by healthcare professionals, including those at point-of-care sites, as a preliminary screening test. Requires confirmation by an alternate chemical method, preferably 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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MAY - 3 2004

#### 510(k) SUMMARY 8.

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

K040274 The Assigned 510(k) number is __

### Submitter:

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

Tel.: [phone] Fax: [phone]

### Date:

February 2, 2004

### Contact Person:

Edward Tung, Ph.D.

### Product Names:

ACON® OPI II One Step Opiate Test Strip ACON® OPI II One Step Opiate Test Device

### Common Name:

Immunochromatographic test for the qualitative detection of Opiate in urine.

### Regulation Name:

Opiates test system.

### Product Code:

DJG

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### Classification Number:

### 21 CFR, 862.3650

### Device Classification:

The Opiate test systems have been classified as Class II devices with moderate complexity. The ACON OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device are similar to another FDA-cleared device for the qualitative detection of Opiate 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® OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device are rapid chromatographic immunoassays for the qualitative detection of Opiate in urine at a cutoff concentration of 2,000 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 OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Opiate 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 Opiate and its metabolite in urine at a cutoff concentration of 2,000 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 Opiate at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

### Comparison to a Predicate Device:

A comparison of the features of the ACON OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device versus a FDA-cleared Opiate Test Device with 2,000 ng/mL Opiate cutoff is shown below:

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- Both tests are assays intended for the qualitative detection of Opiate 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 Opiate . 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 Opiate concentration of 2,000 ng/mL. �

#### Safety and Effectiveness Data:

#### Accuracy

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

### A CON OPI II One Step Opiate Test Strip versus FDA-cleared Opiate Test Device:

Positive Agreement: 131 / 132 = 99% (96 % - 99 %*) Negative Agreement: 168 / 168 > 99% (98 % - 99 % **) Overall Agreement: 299 / 300 > 99% (98 % - 99 %*) * 95% confidence intervals

** Since the proportion can not go above 100%, this is really a 97.5% confidence interval

### ACON OPI II One Step Opiate Test Device versus FDA-cleared Opiate Test Device :

Positive Agreement: 131 / 132 = 99% (96 % - 99 %*) Negative Agreement: 168 / 168 > 99% (98 % - 99 % **) Overall Agreement: 299 / 300 > 99% (98 % - 99 %*) * 95% confidence intervals

** Since the proportion can not go above 100%, this is really a 97.5% confidence interval

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## ACON OPI II One Step Opiate Test Strip versus data obtained with GC/MS at the cutoff concentration of 2,000 ng/mL:

| | | Specimen Cutoff Range by GC/MS Data | | | | | % Agreement with GC/MS Data |
|---------------------------------|----------|-------------------------------------|---------------|----------------|----------------|---------------|-----------------------------|
| | | Negative | < -25% Cutoff | -25% to Cutoff | Cutoff to +25% | > +25% Cutoff | |
| ACON<br>OPI II<br>Test<br>Strip | Positive | 0 | 0 | 2 | 20 | 109 | 98%<br>(95% - 99%)* |
| ACON<br>OPI II<br>Test<br>Strip | Negative | 150 | 0 | 14 | 3 | 2 | 97%<br>(93% - 99%)* |

* Denotes 95% Confidence Interval.

ACON OPI II One Step Opiate Test Device versus data obtained with GC/MS at the cutoff concentration of 2,000 ng/mL

| | | Specimen Cutoff Range by GC/MS Data | | | | % Agreement with GC/MS Data | |
|---------------------------------|----------|-------------------------------------|---------------|----------------|-------------------------|-----------------------------|---------------------|
| | | Negative | < -25% Cutoff | -25% to Cutoff | Cutoff to > +25% Cutoff | | |
| ACON<br>OPI II<br>Test<br>Strip | Positive | 0 | 0 | 2 | 20 | 109 | 98%<br>(95% - 99%)* |
| | Negative | 150 | 0 | 14 | 3 | 2 | 97%<br>(93% - 99%)* |

### Performance Characteristics and Other information:

The performance characteristics of ACON OPI II One Step Opiate Test Strip, ACON OPI II One Step Opiate 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.

### Conclusion:

These clinical studies demonstrated substantial equivalency on performance between the ACON OPI II One Step Opiate Test Strip, ACON OPI II One Step Opiate Test Device and a FDA-cleared Opiate Test Device with the same Opiate cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Opiate at a concentration of 2,000 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/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 3 2004

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

Re: k040274

> Trade/Device Name: ACON OPI II One Step Opiate Test Strip ACON OPI II One Step Opiate Test Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test System Regulatory Class: Class II Product Code: DJG Dated: February 4, 2004 Received: February 5, 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 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (QS) 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/dsma/dsmamain.html.

Sincerely vours.

Jean M. Cooper, MS, DVM.
MS, DVM.

Yean 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

#### 510(k) Number:

K040274

#### Device Name:

ACON OPI II One Step Opiate Test Strip and ACON OPI II One Step Opiate Test Device

#### Indications for Use:

The ACON OPI II One Step Opiate Test Strip or the ACON OPI II One Step Opiate Test The FCON OFFIC one chromatographic immunoassay for the qualitative detection of Dovice is a lacerar now ext a cut-off concentration of 2,000 ng/mL. It is a prescription oplaces in numan anne a battern > professionals including those at the point of care sites.

This assay provides only a preliminary analytical test result. A more specific alternate Themical 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

**Division Sign-Off**

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagne Device Evaluation an

510(k) K040274

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