ACON ONE STEP DRUG SCREEN TEST CARD

K020771 · ACON Laboratories, Inc. · DIO · May 15, 2002 · Clinical Toxicology

Device Facts

• Record ID: K020771
• Device Name: ACON ONE STEP DRUG SCREEN TEST CARD
• Applicant: ACON Laboratories, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The ACON One Step Drug Screen Test Card and ACON One Step Drug Screen Test Card with Integrated Cup are rapid chromatographic immunoassay devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine. The test is calibrated using analytes with their respective cutoff concentrations listed in the following table. [Table omitted for brevity]. The configurations of the ACON One Step Multi-Drug Screen Test Card and ACON One Step Multi-Drug Screen Test Card with Integrated Cup come with any combination of the above listed drug analytes. They are intended for the healthcare professionals including professionals at point-of-care sites.

Device Story

Rapid chromatographic immunoassay for qualitative drug screening in human urine. Device utilizes competitive binding lateral flow technology with mouse monoclonal antibodies to detect specific drug analytes. Input is human urine specimen; output is visual colored-line presence/absence in test region. No instrumentation required. Used by healthcare professionals at point-of-care sites. Positive result indicated by absence of colored line in test region; negative result indicated by colored line. Procedural control line confirms proper specimen volume and membrane wicking. Provides preliminary analytical results to assist in clinical decision-making regarding drug presence.

Clinical Evidence

No clinical data provided; device relies on bench testing of analytical performance (cutoff concentrations and qualitative detection).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; mouse monoclonal antibodies; visual readout; no instrumentation; point-of-care use.

Indications for Use

Indicated for healthcare professionals at point-of-care sites for qualitative, simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and barbiturates in human urine at specified cutoff concentrations.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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 1 5 2002

K020771

#### 510(k) SUMMARY 7.

This 510 (k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Assigned 510(k) number is K020771.

#### Submitter:

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

Tel.: [phone] Fax: [phone]

#### Date:

March 4, 2002

### Contact Person:

Edward Tung, Ph.D.

#### Product Names:

ACON® One Step Drug Screen Test Card ACON® One Step Drug Screen Test Card with Integrated Cup

#### Common Name:

test for the qualitative detection of of Marijuana. Cocaine. Immunochromatographic Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and barbiturate in human urine.

#### Device Classification:

The ACON One Step Drug Screen Test Card ACON One Step Drug Screen Test Card with Integrated Cup is similar to other FDA-cleared devices for the qualitative and simultaneous detection of drugs in urine specimens. These drug test devices are used only to provide a preliminary analytical result (21 CFR 862.3650). The test systems have been classified as Class II devices with moderate complexity. Product codes LDJ, DIO, LAF, DKZ, DJG, LCM, JXM, DJR, and DIS have been assigned for the test system.

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# Classification Name:

Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and barbiturate test systems

# Intended Use:

The ACON One Step Drug Screen Test Card and ACON One Step Drug Screen Test Card with Integrated Cup are rapid chromatographic immunoassay devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine. The test is calibrated using analytes with their respective cutoff concentrations listed in the following table.

| Test | Calibrator | Cut-off |
|-------------------------------|--------------------------------|-------------|
| Amphetamine (AMP) | D-Amphetamine | 1,000 ng/mL |
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methamphetamine (mAMP) | D-Methamphetamine | 1,000 ng/mL |
| Morphine (MOP 300 or OPI 300) | Morphine | 300 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Opiates (OPI 2000) | Morphine | 2,000 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Marijuana (THC) | 11-nor- $\Delta^9$ -THC-9 COOH | 50 ng/mL |

The configurations of the ACON One Step Multi-Drug Screen Test Card and ACON One Step Multi-Drug Screen Test Card with Integrated Cup come with any combination of the above listed drug analytes. They are intended for the healthcare professionals including professionals at point-of-care sites.

# Description:

The ACON One Step Drug Screen Test card are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous screening of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine.

The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Marijuana, Cocaine, Methamphetamine. Amphetamine. Opiates. Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in urine. 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 the drug concentration below the cut-off 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 applied and membrane wicking has occurred.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

MAY 1 5 2002

Re: k020771

Trade/Device Names: ACON® One Step Drug Screen Test Card ACON® One Step Drug Screen Test Card with Integrated Cup Regulation Numbers: 21 CFR 862.3610; 21 CFR 862.3650; 21 CFR 862.3100; 21 CFR 862.3150; 21 CFR 862.3170; 21 CFR 862.3870; 21 CFR 862.3250; 21 CFR 862.3640; 21 CFR 862.3620 Regulation Names: Methamphetamine test system; Opiate test system; Amphetamine test system: Barbiturate test system: Benzodiazephine test system: Cannabinoid test system; Cocaine and cocaine metabolite test system;

Morphine test system; Methadone test system

Regulatory Class: Class II

Product Codes: DJG; LCM; DKZ; DIS; JXM; LDJ; DIO; DPK; DJR Dated: March 6, 2002 Received: March 8, 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, 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.

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#### Page 2

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.

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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 Part 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 Sutman

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

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#### INDICATIONS FOR USE 10.

K020771 510(k) Number:

ACON One Step Drug Screen Test Card Device Name: ACON One Step Drug Screen Test Card with Integrated Cup

### Indications for Use:

The ACON One Step Drug Screen Test Card and ACON One Step Drug Screen Test Card with Integrated Cup are rapid chromatographic immunoassay devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, and/or barbiturate in human urine. The test is calibrated against analytes with their respective cutoff concentrations listed in the following table.

| Test | Calibrator | Cut-off |
|-------------------------------|--------------------------------|-------------|
| Amphetamine (AMP) | D-Amphetamine | 1,000 ng/mL |
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methamphetamine (mAMP) | D-Methamphetamine | 1,000 ng/mL |
| Morphine (MOP 300 or OPI 300) | Morphine | 300 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Opiates (OPI 2000) | Morphine | 2,000 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Marijuana (THC) | 11-nor- $\Delta^9$ -THC-9 COOH | 50 ng/mL |

The configurations of the ACON One Step Multi-Drug Screen Test Card and ACON One Step Multi-Drug Screen Test Card with Integrated Cup come with any combination of the above listed drug analytes. They are intended for the healthcare professionals including professionals at point-of-care sites. (Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K220771

(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 **__**