ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE

K022589 · ACON Laboratories, Inc. · LAF · Oct 28, 2002 · Clinical Toxicology

Device Facts

• Record ID: K022589
• Device Name: ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Oct 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The ACON® MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are rapid chromatographic immunoassays for the qualitative detection of MDMA in urine at a cutoff concentration of 500 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

Device Story

Lateral flow immunochromatographic assay; detects MDMA in human urine; competitive binding principle using antigen-antibody interactions. Input: urine sample; Output: visual colored line in test region (negative) or absence of line (positive); procedural control line confirms proper wicking. Used at point-of-care sites by healthcare professionals. Provides preliminary analytical result; requires confirmation by alternative method (e.g., GC/MS). Benefits patient by enabling rapid screening for MDMA presence.

Clinical Evidence

Clinical evaluation of 240 urine specimens compared ACON test strips/devices against a predicate device and GC/MS. Results showed 100% positive agreement and 99% negative agreement. Overall agreement was 99% (95% CI: 98%-99%). Study included samples near the cutoff range (+/- 25%).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding format; visual qualitative readout; 500 ng/mL cutoff concentration. No instrumentation required. Standalone test strip or device format.

Indications for Use

Indicated for healthcare professionals at point-of-care sites for the qualitative detection of MDMA in human urine at a 500 ng/mL cutoff concentration.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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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# OCT 2 8 2002

#### 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.

The Assigned 510(k) number is K022589.

#### Submitter:

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

Tel.: [phone] Fax: [phone]

#### Date:

July 30, 2002

### Contact Person:

Edward Tung, Ph.D.

### Product Names:

ACON® MDMA One Step Ecstasy Test Strip ACON® MDMA One Step Ecstasy Test Device

### Common Name:

Immunochromatographic test for the qualitative detection of MDMA in urine.

#### Device Classification:

The ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are similar to other FDA-cleared devices for the qualitative detection of MDMA in urine specimens. These tests are used to provide a preliminary analytical

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result. MDMA test systems have been classified as Class II devices with moderate complexity.

#### Classification Name:

Methylenedioxymetamphetamines (MDMA) test system

#### Intended Use:

The ACON® MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are rapid chromatographic immunoassays for the qualitative detection of MDMA in urine at a cutoff concentration of 500 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

#### Description:

The ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of MDMA in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of MDMA in urine at a cutoff concentration of 500 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 MDMA 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 MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device versus a FDA-cleared MDMA (Ecstasy) Test is shown below:

- . Both tests are assays intended for the qualitative detection of MDMA 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 MDMA with a visual, qualitative end result.

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- 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 cut-off MDMA concentration of 500 ng/mL. ●

#### Safety and Effectiveness Data:

#### Accuracy

A clinical evaluation was conducted using 240 clinical urine specimens including approximately 12% of the MDMA containing specimens with MDMA concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON® MDMA One Step Ecstasy Test Strip and ACON® MDMA One Step Ecstasy Test Device with a FDA-cleared MDMA Ecstasy Test; as well as comparing against data obtained from the customary Gas ChromatographyMass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:

#### A CON MDMA One Step Ecstasy Test Strip versus FDA-cleared MDMA Test:

Positive Agreement: 90 / 90 = 100% (96% - >99%*) Negative Agreement: 149 / 150 = 99% (96% - >99%*) Overall Agreement: 239/ 240 = 99% (98% - >99%*)

* Denotes 95% Confidence Intervals.

#### ACON MDMA One Step Ecstasy Test Device versus FDA-cleared MDMA Test:

Positive Agreement: 90 / 90 = 100% (96% - >99%*) Negative Agreement: 149 / 150 = 99% (96% - >99%*) Regative Pigroement: 1177 136 = 99% (98% - 99% (98% - 99%*)

* Denotes 95% Confidence Intervals

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ACON MDMA One Step Ecstasy Test Strips were tested with 93 MDMA positive and 147 MDMA negative urine samples in a clinical study. Nine of these positive urine samples in the +/- 25% cutoff range were derived from the concentrated MDMA clinical specimens; the rest were true clinical specimens. All positive samples used in this study were confirmed by GC/MS. Negative clinical samples were screened by a commercial MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by GC/MS. The following results were tabulated.

| | | Negative | -25% cutoff to<br>cutoff | Cutoff to +25%<br>cutoff | >+25% cutoff |
|-----------------------|----------|----------|--------------------------|--------------------------|--------------|
| ACON<br>MDMA<br>Strip | Positive | | | | 82 |
| | Negative | 147 | | | |

ACON MDMA One Step Ecstasy Test Devices were also tested with 93 MDMA positive and 147 MDMA negative urine samples in a clinical study. Nine of these positive urine samples in the +/- 25% cutoff range were derived from the concentrated MDMA clinical specimens; the rest were true clinical specimens. All positive samples used in this study were confirmed by GC/MS. Negative clinical samples were screened by a commercial MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by GC/MS. The following results were tabulated.

| | | Negative | -25% cutoff to<br>cutoff | Cutoff to +25%<br>cutoff | >+25% cutoff |
|------------------------|----------|----------|--------------------------|--------------------------|--------------|
| ACON<br>MDMA<br>Device | Positive | 0 | 3 | 6 | 82 |
| | Negative | 147 | 2 | 0 | 0 |

#### Conclusion:

These clinical studies demonstrated substantial equivalency on performance between the ACON MDMA One Step Ecstasy Test Strip, ACON MDMA One Step Ecstasy Test Device and a FDA-cleared Ecstasy Test, which is being marketed in the United States. It is also demonstrated that these tests are safe and effective in qualitatively detecting MDMA at a concentration of 500 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 (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 2 8 2002

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

k022589 Re:

> Trade/Device Name: ACON® MDMA One Step Ecstasy Test Strip ACON® MDMA One Step Ecstasy Test Device Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF Dated: August 1, 2002 Received: August 5, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 10. INDICATIONS FOR USE

510(k) Number:

K022589

Device Name: ACON® MDMA One Step Ecstasy Test Strip

ACON® MDMA One Step Ecstasy Test Device

Indications for Use:

The ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are rapid chromatographic the immunoassays detection Methylenedioxymethamphetamine (MDMA) in human urine at a designated cutoff concentration of 500 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

(Per 21 CFR 801.109)

Or

Over-The-Counter Use

Tonlough

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number