SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

K020769 · Lin-Zhi International, Inc. · DLJ · Apr 3, 2002 · Clinical Toxicology

Device Facts

• Record ID: K020769
• Device Name: SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
• Applicant: Lin-Zhi International, Inc.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine. The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

Device Story

Device consists of human urine-based liquid calibrators and controls; used for calibration and validation of enzyme immunoassays (EIA) for drugs of abuse (phencyclidine, opiates, cocaine metabolite, amphetamines). Negative calibrator is drug-free human urine; other levels prepared by spiking known drug concentrations. Concentrations confirmed via GC/MS. Used in clinical laboratory settings by laboratory professionals. Output provides reference points for assay calibration and quality control validation; ensures accuracy of patient urine drug screening results. Benefits include standardized, reliable detection of drug analytes in clinical toxicology testing.

Clinical Evidence

No clinical data. Performance characteristics (precision, accuracy, stability) established via bench testing. Nominal concentrations confirmed by GC/MS.

Technological Characteristics

Human urine-based liquid matrix; ready-to-use. Analyte concentrations confirmed by GC/MS. Storage at 2°C to 8°C. No unique technical characteristics; standard chemical calibrator/control formulation.

Indications for Use

Indicated for in vitro diagnostic calibration and validation of enzyme immunoassays detecting phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

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

• Drugs of Abuse Urine Calibrators and Controls (K983159)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

APR 0 3 2002

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:

Contact: Chiu Chin Chang, Ph.D. 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: | Phencyclidine Calibrators,<br>Opiate Calibrators,<br>Cocaine Calibrators, and<br>Amphetamine Calibrators |
| Proprietary Name: | None |
| (b) Classification Name: | Single (Specified) Analyte Controls (Assayed and Unassayed);<br>Class I, LAS (91 Toxicology), 21 CFR 862.3280 |
| Common/Usual Name: | Phencyclidine Controls,<br>Opiate Controls,<br>Cocaine Controls, and<br>Amphetamines Controls |
| Proprietary Name: | None |

#### Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.' Single Analyte Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to the Drugs of Abuse Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notification K983159.

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# Device Description

All of the Single Analyte 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. When applicable, they contain known concentration of a specific drug analyte.

The Negative DAU Calibrator is a processed, drug-free human urine matrix. The Low, Cutoff, Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:

| | Phencyclidine EIA | Opiate EIA | Cocaine Metabolite EIA | Amphetamines EIA |
|-------------------------|-------------------|------------|------------------------|-------------------|
| Reference Material | Phencyclidine | Morphine | Benzoylecgonine | d-Methamphetamine |
| Low Calibrator | 12.5 ng/mL | 150 ng/mL | 150 ng/mL | 500 ng/mL |
| Cutoff Calibrator | 25 ng/mL | 300 ng/mL | 300 ng/mL | 1000 ng/mL |
| Intermediate Calibrator | 50 ng/mL | 600 ng/mL | 1000 ng/mL | 1500 ng/mL |
| High Calibrator | 100 ng/mL | 1000 ng/mL | 3000 ng/mL | 2000 ng/mL |
| Control Level 1 | 18 ng/mL | 225 ng/mL | 225 ng/mL | 750 ng/mL |
| Control Level 2 | 32 ng/mL | 375 ng/mL | 375 ng/mL | 1250 ng/mL |

The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed by GC/MS.

# Intended Use

The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

## Comparison to Predicate Device

LZI's Single Analyte Urine DAU Calibrators and Controls are similar in intended use, matrix, and performance to the DRI's Drugs of Abuse Urine Calibrators and Controls.

Similarities:

- Both are for the calibration and validation of DAU enzyme immunoassays to detect the . same commonly abused drug analytes (phencyclidine, opiates, cocaine metabolite, or amphetamines) in human urine.

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- The cutoff concentration for each analyte is the same per recommendations of The . Substance Abuse and Mental Health Services Administration (SAMHSA).
- Both use 2 levels of Controls, and the concentrations are set at equal to or approximately . ± 25% of the cutoff concentration for each analyte according to the SAMHSA guideline.
- The nominal concentrations of the analyte in the calibrators and controls are determined . and confirmed by 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. �

| Characteristics | DRI's DAU Urine<br>Calibrators and Controls | LZI's Single Analyte Urine<br>DAU Calibrators and Controls |
|--------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| No. of Analytes in each<br>Calibrator or Control | All 4 drugs in each Calibrator or Control | Single drug only in each<br>Calibrator or Control. |
| No. of Calibrators | 3 levels* including the<br>Negative Calibrator. | 5 levels including the Negative<br>Calibrator |
| Nomenclature/Labeling<br>of Calibrators | Negative, Low (= Cutoff),<br>and High | Negative, Low, Cutoff,<br>Intermediate, and High |
| Concentration of<br>Analyte(s) | Phencyclidine Controls: 20<br>and 35 ng/mL<br>Cocaine High Calibrator:<br>1000 ng/mL | Phencyclidine Controls: 18 and<br>32 ng/mL,<br>Cocaine High Calibrator: 3000<br>ng/mL |

Differences:

* Additional calibrators are now available. Currently 5 levels of calibrators (Cal 0, 1, 2, 3, and 4) are available from DRI/Microgenics Corp. (under "Multi-drug Urine Calibrators and Controls" product name).

# Conclusion

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services U.S.A. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract shapes resembling human profiles or figures, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

## APR 0 3 2002

k020769 Re:

Trade/Device Name: Single Analyte Urine Drugs of Abuse Calibrators and Controls Regulation Number: 21 CFR 862.3280; 21 CFR 862.3200 Regulation Name: Clinical toxicology control material; Clinical toxicology calibrator Regulatory Class: Class I; Class II Product Code: LAS; DLJ Dated: February 28, 2002 Received: March 7, 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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#### 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 Putman

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): K020769

Device Name: Single Analyte Urine Drugs of Abuse Calibrators and Controls

#### Indications for Use:

The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

P. Bernhardt for J. Cooper

ision of Clinical Laboratory Devices 510(k) Number LO2 O

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)