CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

K021449 · Lin-Zhi International, Inc. · DLJ · Jun 18, 2002 · Clinical Toxicology

Device Facts

• Record ID: K021449
• Device Name: CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
• Applicant: Lin-Zhi International, Inc.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Jun 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The Cannabinoid Urine DAU Calibrators are intended for in vitro diagnostic use for the calibration of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine. The Cannabinoid Urine DAU Controls are intended for in vitro diagnostic use for the validation of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

Device Story

Device consists of human urine-based liquid calibrators and controls containing known concentrations of 11-nor-Δ9-THC-9-Carboxylic Acid; used in clinical laboratories to calibrate and validate cannabinoid enzyme immunoassays. Analyte concentrations are confirmed via GC/MS. Calibrators and controls are ready-to-use; stored at 2°C to 8°C. Healthcare providers use these materials to ensure accuracy and precision of urine drug screening tests for cannabinoids. Benefits include standardized assay performance and reliable detection of THC abuse in accordance with SAMHSA cutoff recommendations.

Clinical Evidence

No clinical data. Bench testing only. Performance characteristics including precision, accuracy, and stability were evaluated and compared to predicate devices.

Technological Characteristics

Human urine-based liquid matrix; ready-to-use. Analyte: 11-nor-Δ9-THC-9-Carboxylic Acid. Concentration verification via GC/MS. Storage: 2°C to 8°C. No unique technical characteristics.

Indications for Use

Indicated for in vitro diagnostic use to calibrate and validate cannabinoid (THC) enzyme immunoassays in human urine samples. Intended for clinical laboratory use.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

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

Predicate Devices

• A-Cannabinoid (THC) Urine Calibrators and Controls (K923386)
• A-Cannabinoid (THC) Urine Calibrators and Controls (932113)

Submission Summary (Full Text)

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KO21449

# 510(k) Summary of Safety and Effectiveness

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

## Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

#### Submitter name, Address, and Contact

Lin-Zhi International, Inc. 2391 Zanker Road, Suite 340 San Jose, CA 95131 Phone: [phone] [phone] Fax:

Chiu Chin Chang, Ph.D. Contact: VP, R&D

#### Device Name and Classification

| (a) Classification Name: | Calibrators, Drug Specific;<br>Class II, DLJ (91 Toxicology), 21 CFR 862.3200 |
|--------------------------|-----------------------------------------------------------------------------------|
| Common/Usual Name: | Cannabinoid Calibrators |
| Proprietary Name: | None |
| (b) Classification Name: | Drug Specific Control Materials;<br>Class I, LAS (91 Toxicology), 21 CFR 862.3280 |
| Common/Usual Name: | Cannabinoid Controls |
| Proprietary Name: | None |

## Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.' Cannabinoid Urine Drugs of Abuse (DAU) Calibrators and Controls are substantially equivalent to the A-Cannabinoid (THC) Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notifications K923386 and 932113.

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# Device Description

ﺮﮮ ﮐﮯ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔

All of the Cannabinoid Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. They each contain a known concentration of 11-nor-A -THC-9-Carboxylic Acid.

All of the Cannabinoid Urine DAU Calibrators and Controls are prepared by spiking known concentrations of 11-nor-A -THC-9-Carboxylic Acid into the Negative DAU Calibrator. which is a processed, drug-free human urine-based matrix. The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed by GC/MS.

## Intended Use

The Cannabinoid Urine DAU Calibrators are intended for in vitro diagnostic use for the calibration of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

The Cannabinoid Urine DAU Controls are intended for in vitro diagnostic use for the validation of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

## Comparison to Predicate Device

LZI's Cannabinoid Urine DAU Calibrators and Controls are similar in intended use, matrix. and performance to the DRI's A -Cannabinoid (THC) Urine Calibrators and Controls.

Similarities:

Both are for the calibration and validation of Cannabinoid Enzyme Immunoassav to detect cannabinoids (THC) in human urine.

- The cutoff concentration(s) for the analyte are the same. which include the cutoff of 50 . ng/mL per recommendation of The Substance Abuse and Mental Health Services Administration (SAMHSA) for the initial screening test of cannabinoids (THC) abuse. The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed bv GC/MS.
- . Both are urine-based liquids. Storage condition is the same, at 2℃ to 8℃. Performance characteristics on precision, accuracy and stability are similar.

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# Comparison to Predicate Device (continued)

Differences:

| Characteristics | DRI's Δ9-Cannabinoid<br>(THC) Urine<br>Calibrators and Controls | LZI's Cannabinoid Urine<br>DAU Calibrators and Controls |
|-----------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|
| No. of Calibrators | 5 levels including the<br>Negative Calibrator. | A total of 9 levels including<br>the Negative Calibrator are<br>available. |
| No. of Controls | 4 levels of controls available | 2 levels of controls for each<br>cutoff assay. |
| Concentration of<br>Analyte | 0, 20, 40, 50, 60, 75, 100,<br>125, and 200 ng/mL | 0, 10, 20, 30, 37.5, 50, 62.5,<br>75, 100, 125, 150, and 200<br>ng/mL |

## Conclusion

The information provided in the premarket notification demonstrates that the LZI's Cannabinoid Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to previously approved predicate devices, notably the DRI's A -Cannabinoid (THC) Urine Calibrators and Controls, and safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." are arranged in a circle around the eagle image.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN 1 8 2002

Chiu Chin Chang, Ph.D. VP. R&D Lin-Zhi International. Inc. 2391 Zanker Road, Suite 340 San Jose. CA 95131

Re: k021449

> Trade/Device Name: Cannabinoid Urine Drugs of Abuse Calibrators and Controls Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical Toxicology Calibrator Regulatory Class: Class II Product Code: DLJ Dated: April 29, 2002 Received: May 6, 2002

Dear Dr. Chang:

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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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/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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# Premarket Notification

# Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

#### Device Name: Cannabinoid Urine Drugs of Abuse Calibrators and Controls

#### Indications for Use:

The Cannabinoid Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

The Cannabinoid Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

Jean

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021449

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)