ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE

K013380 · ACON Laboratories, Inc. · DJG · Dec 18, 2001 · Clinical Toxicology

Device Facts

• Record ID: K013380
• Device Name: ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

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

Device Story

Rapid chromatographic immunoassay for qualitative screening of opiates in urine; competitive binding lateral flow principle; utilizes mouse monoclonal antibody to detect morphine at 300 ng/mL cut-off. Instrument-free; visual readout. Positive result: absence of colored line in test region; negative result: presence of colored line. Procedural control line confirms proper wicking. Used by healthcare professionals in point-of-care settings. Provides preliminary analytical result; requires confirmation by alternative chemical method (e.g., GC/MS). Benefits include rapid, on-site screening for opiate presence.

Clinical Evidence

Clinical evaluation of 300 urine specimens compared ACON test formats against predicate device and GC/MS. Results: 100% positive/negative agreement with predicate device. Comparison against GC/MS at 300 ng/mL cut-off showed 100% positive agreement, 94% negative agreement, and 97% overall agreement. Study included 10% of samples near the cut-off range (±25%).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding format. Utilizes mouse monoclonal antibodies. Form factors: test strip and test device. Instrument-free operation. Qualitative visual readout.

Indications for Use

Indicated for healthcare professionals for the qualitative detection of opiates in human urine at a cut-off concentration of 300 ng/mL.

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).

Predicate Devices

• Screener Opiate Test Drugscreen™ DIP Opiate Test (K000273)

Submission Summary (Full Text)

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# DEC 1 82001

#### SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS 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 K-013380.

# Submitter:

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

Tel.: [phone] Fax: [phone]

Date: October 5, 2001

Contact Person: Edward Tung, Ph.D.

### Product Names:

ACON® MOP One Step Opiate Test Strip ACON® MOP One Step Opiate Test Device

### Common Name:

Immunochromatographic test for the qualitative detection of Opiates in urine

# Device Classification:

The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are similar to other FDA-cleared devices for the qualitative detection of Opiates in urine specimens. These tests are used to provide a preliminary analytical result (21 CFR 862.3650). These test systems have been classified as Class II devices with moderate complexity. Product code DJG has been assigned for these Opiate test systems.

# Classification Name:

Opiate test system

### Intended Use:

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

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# Description:

The ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Opiates in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Opiates in urine at a cut-off concentration of 300 ng/mL for morphine. 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 Opiates at the concentration wills a logan of 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:

Screener Opiate Test Drugscreen™ DIP Opiate Test 510(k) Number: K000273

# Comparison to a Predicate Device:

- A comparison of the features of the ACON MOP One Step Opiate Test Strip and ACON MOP One Step Opiate Test Device versus the Screener Opiate Test Drugscreen™ DIP Opiate Test is shown below:
- Both tests are assays intended for the qualitative detection of Opiates 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 . Opiates 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 for morphine concentration of 300 ng/mL. .

# Safety and Effectiveness Data:

#### Accuracy:

A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with Opiate concentrations at -25% cut-off to +25% cut-off range. This evaluation compared the test results between ACON® MOP One Step Opiate Test Strip and Test Device with Screener Opiate Test Drugscreen™ DIP Opiate Test; as well as against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:

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ACON MOP One Step Opiate Test Strip versus the Screener Opiate Test Drugscreen™ DIP Opiate Test:

> Positive Agreement: 150 / 150 = 100% (98% - 100%*) Negative Agreement: 150 / 150 = 100% (98% - 100%*) Overall Agreement: 300 / 300 = 100% (98% - 100%*)

> > * 95% Confidence Intervals

ACON MOP One Step Opiate Test Device versus Screener Opiate Test Drugscreen™ DIP Opiate Test:

> Positive Agreement: 150 / 150 = 100% (98% - 100%*) Negative Agreement: 150 / 150 = 100% (98% - 100%*) Overall Agreement: 300 / 300 = 100% (98% - 100%*)

> > * 95% Confidence Intervals

ACON MOP One Step Opiate Test Strip versus GC/MS at the cut-off of 300 ng/ml:

Positive Agreement: 141 / 141 = 100% (97% - 100%*) Negative Agreement: 150 / 159 = 94% (89% - 97%*) Overall Agreement: 291 / 300 = 97% (94% - 98%*)

* 95% confidence intervals

ACON MOP One Step Opiate Test Device versus GC/MS at the cut-off of 300 ng/ml:

Positive Agreement: 141 / 141 = 100% (97% - 100%*) Negative Agreement: 150 / 159 = 94% (89% - 97%*) Overall Agreement: 291 / 300 = 97% (94% - 98%*)

* 95% confidence intervals

#### Conclusion:

These clinical studies demonstrate the substantial equivalency between the ACON MOP One Step Opiate Test Strip, ACON MOP One Step Opiate Test Device and Screener Opiate Test Drugscreen™ DIP Opiate Test, which has already being marketed in the United States. It is also demonstrated that these tests are safe and effective in detecting Opiates at a concentration of 300 ng/mL. They are intended for healthcare professionals' The POL study demonstrated that these tests are also suitable for healthcare use. professionals at point-of-care site use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

DEC 1 8 2001

Re: k013380

Trade/Device Name: ACON® MOP One Step Opiate Test Strip and ACON® MOP One Step Opiate Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: October 11, 2001 Received: October 12, 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/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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#### INDICATIONS FOR USE 10.

510(k) Number:

Kor3380

Device Name: ACON® MOP One Step Opiate Test Strip

ACON® MOP One Step Opiate Test Device

Indications for Use:

The ACON MOP One Step Opiate Test Strip and ACON MOP The ACON MOT One Diop Opice are rapid chromatographic One Step Oplate Test Totalitative detection of Opiate in human Infinunoassays for the qualitation of 300 ng/mL. They are intended for healthcare professional use.

Thomas L. Darts for Jean Cooper
10/16/2023

ion Sigr (Division Sign-On)
Division of Clinical Laboratory Devices KO13380 510(k) Number

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_*** Or over-the-counter Use **_**

(Per 21 CFR 801.109)