ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE

K012595 · ACON Laboratories, Inc. · DJR · Oct 15, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012595
• Device Name: ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Oct 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The ACON® MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of methadone in urine at a cut-off concentration of 300 ng/mL. They are intended for professional and healthcare professional use.

Device Story

Lateral flow immunochromatographic assay; detects methadone in urine samples. Principle: competitive binding antigen-antibody immunochemistry. Input: urine specimen; output: visual colored line in test region (negative) or absence of line (positive). Control line confirms proper wicking/volume. Used in professional/point-of-care settings; operated by healthcare professionals. No instrumentation required. Provides preliminary analytical result; assists clinical decision-making regarding methadone presence.

Clinical Evidence

Clinical evaluation of 300 urine specimens. Compared against LifeSign Status DS MTD and GC/MS. Results vs. predicate: 100% positive, negative, and overall agreement. Results vs. GC/MS: 99% positive agreement, 94% negative agreement, 96% total agreement.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding format. Visual qualitative readout. No energy source required. Standalone test strip or device format.

Indications for Use

Indicated for qualitative detection of methadone in human urine at 300 ng/mL cutoff. Intended for healthcare professionals and professional point-of-care use.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone 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

• LifeSign Status DSTM MTD One-Step Methadone Test (K991080)

Submission Summary (Full Text)

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# OCT 1 5 2001

#### 8. SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS

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 Kolla595 - Color September i

# Submitter:

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

Tel.: [phone] Fax: [phone]

Date: August 6, 2001

Contact Person: Edward Tung, Ph.D.

# Product Names:

ACON® MTD One Step Methadone Test Strip

ACON® MTD One Step Methadone Test Device

### Common Name:

Immunochromatographic test for the qualitative detection of methadone in urine

### Device Classification:

The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are similar to other FDA-cleared devices for the qualitative detection of methadone in urine specimens. These tests are used to provide a preliminary analytical result (21 CFR 862.3620). Methadone test systems have been classified as Class II devices with moderate complexity.

### Classification Name:

Methadone test system

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# Intended Use:

The ACON® MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of methadone in urine at a cut-off concentration of 300 ng/mL. They are intended for professional and healthcare professional use.

# Description:

The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of methadone 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 methadone in urine at a cut-off concentration of 300 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 methadone 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 will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

# Predicate Device:

LifeSign Status DSTM MTD One-Step Methadone Test

510(k) Number: K991080

# Comparison to a Predicate Device:

A comparison of the features of the ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device versus the LifeSign Status DS™ MTD One-Step Methadone Test is shown below:

- Both tests are assays intended for the qualitative detection of methadone 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 ● methadone 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 cut-off methadone concentration of 300 ng/mL.

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# Safety and Effectiveness Data:

### Accuracy

A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with methadone concentrations at -25% cut-off range. This evaluation samples with memations concentrations at 25% on. On . Step Methadone Test Strip and Test Device with LifeSign Status DSM MTD One-Step Methadone Test; as well as against data Dovio with Enebig. Das Chromatography/Mass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:

ACON MTD One Step Methadone Test Strip versus LifeSign Status DSTM MTD One- Step Methadone Test:

> Positive Agreement: 132 / 132 = 100% (97% - 100%*) Negative Agreement: 168 / 168 = 100% (98% - 100%*) Overall Agreement: 300 / 300 = 100% (99% - 100%*)

> > * 95% Confidence Intervals

ACON MTD One Step Methadone Test Device versus the LifeSign Status DS™ MTD One-Step Methadone Test:

> Positive Agreement: 132 / 132 = 100% (97% - 100%*) Negative Agreement: 168 / 168 = 100% (98% - 100%*) Overall Agreement: 300 / 300 = 100% (99% - 100%*)

> > * 95% Confidence Intervals

ACON MTD One Step Methadone Test Strip versus GC/MS at the cutoff of 300 ng/ml:

Positive agreement with GC/MS: 122 / 123 = 99% (96% - 100%*) Negative agreement with GC/MS: 167 / 177 = 94% (90% - 97%*) Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)

* 95% confidence intervals

ACON MTD One-Step Methadone Test Device versus GC/MS at the cutoff of 300 ng/ml:

Positive agreement with GC/MS: 122 / 123 = 99% (96% - 100%*) Negative agreement with GC/MS: 167 / 177 = 94% (90% - 97%*) Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)

* 95% confidence intervals

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#### Conclusion:

These clinical studies demonstrate the substantial equivalency between the ACON MTD One Step Methadone Test Strip, ACON MTD One Step Methadone Test Device and the LifeSign Status Monadone Test Datpy Freeddone Test, which has already being marketed in the United States. It is Do - HITD One Diep Sizease tests are safe and effective in detecting methadone at a concentration also connemally demonstrated that these tests are suitable for healthcare professionals and professional point-of-care use.

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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 depiction of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 5 2001

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

k012595 Re:

Trade/Device Name: ACON® MTD One Step Methadone Test Strip and ACON® MTD One Step Methadone Test Device Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: August 8, 2001 Received: August 10, 2001

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, 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 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 1 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/cdrh/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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#### INDICATIONS FOR USE 10.

510(k) Number:

Kolasgs

Device Name: ACON® MTD One Step Methadone Test Strip

ACON® MTD One Step Methadone Test Device

The ACON MTD One Step Methadone Test Strip and ACON MTD One Indications for Use: Step Methadone Test Device are rapid chromatographic immunoassays Blog Moundone in etection of Methadone in human urine at a cut-off They are intended for healthcare concentration of 300 ng/mL. professionals and professional point-of-care use.

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

Prescription Use

(Per 21 CFR 801.109)

Kevia Alexander for Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012595

Or

Over-The-Counter Use_

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