MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

K051088 · Lin-Zhi International, Inc. · DKB · Jun 24, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051088
• Device Name: MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
• Applicant: Lin-Zhi International, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Jun 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine. Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Calibrators intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines. barbiturates, methadone, phencyclidine or propoxyphene in human urine. The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine.

Device Story

Liquid, ready-to-use calibrators and controls; human urine matrix spiked with known concentrations of drug analytes (benzoylecgonine, methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propoxyphene). Used in clinical laboratory settings by technicians to calibrate and validate enzyme immunoassay (EIA) systems for drugs of abuse testing. Calibrators establish assay response curves; controls verify assay performance and accuracy. Values confirmed via GC/MS. Provides standardized reference points for clinical decision-making regarding drug screening results.

Clinical Evidence

No clinical data. Bench testing only. Stability demonstrated over 244 days at 2-8°C and room temperature; concentrations confirmed by GC/MS and HPLC; traceability to USP reference materials established.

Technological Characteristics

Liquid, ready-to-use urine matrix. Calibrators/controls contain spiked drug analytes. Concentrations confirmed by GC/MS and HPLC. Storage at 2-8°C. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to calibrate and validate enzyme immunoassays for the detection of d-methamphetamine, benzoylecgonine, opiates, benzodiazepines, barbiturates, methadone, phencyclidine, or propoxyphene in human urine samples.

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 (K993755)
• DRI Drugs of Abuse Urine Calibrators and Controls (K983159)

Submission Summary (Full Text)

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K051088

#### JUN 2 4 2005

## 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is heing 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. 687 North Pastroia Avenue Sunnyvale, CA 94085 Phone: [phone] Fax: [phone]

| Contact: | Cheng-I Lin, Ph.D |
|----------|-------------------|
| | President |

#### Device Name and Classification

| (A) Classification Name: | Drug Mixture Calibrator Materials<br>Class II, DKB (91 Toxicology), 21 CFR862.3200 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Benzoylecgonine, Methamphetamine, Methadone, Morphine,<br>Oxazepam, Secobarbital, Phencyclidine, Propoxyphene<br>Calibrators |
| Proprietary Name: | None |
| (B) Classification Name: | Drug Mixture Control Materials;<br>Class I, DIF (91 Toxicology), 21 CFR 862.3280 |
| Common/Usual Name: | Benzoylecgonine, Methamphetamine, Methadone, Morphine.<br>Oxazepam, Secobarbital, Phencyclidine, Propoxyphene<br>Controls |
| Proprietary Name: | None |

#### Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.'s Multiple Analyte Urine Drugs of Abuse Calibrators and Controls are prepared according to the SAMHSA's guideline and confirmed with GC/MS. Lin-Zhi International, Inc.' Multiple Analyte Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to the Drugs of Abuse Urine Calibrators and Controls (Dade Behring, Microgenics), cleared under premarket notification K993755 (Dade Behring), K983159 (DRI, now Microgenics).

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## Device Description

All of the DAU Calibrators and Controls are liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte as a mixture.

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:

| | Low<br>Calibrator | Cutoff<br>Calibrator | Intermediate<br>Calibrator | High<br>Calibrator | Control<br>Level 1 | Control<br>Level 2 |
|-----------------|-------------------|----------------------|----------------------------|--------------------|--------------------|--------------------|
| Material | ng/mL | ng/mL | ng/mL | ng/mL | ng/mL | ng/mL |
| Methamphetamine | 250 | 500 | 750 | 1000 | 375 | 625 |
| Secobarbital | 100 | 200 | 500 | 1000 | 100 | 300 |
| Oxazepam | 100 | 200 | 500 | 1000 | 100 | 300 |
| Benzoylecgonine | 75 | 150 | 300 | 1000 | 110 | 190 |
| Methadone | 150 | 300 | 600 | 1000 | 225 | 375 |
| Morphine | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Phencyclidine | 12.5 | 25 | 50 | 100 | 18 | 35 |
| Propoxyphene | 150 | 300 | 600 | 1000 | 225 | 375 |

Multiple Analyte Calibrators and Controls:

## Intended Use

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine. Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Calibrators intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines. barbiturates, methadone, phencyclidine or propoxyphene in human urine.

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine.

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#### Comparison to Predicate Device

LZI's Multiple Analyte urine DAU Calibrators and Controls are prepared according to the SAMHSA published guidelines. They are similar in intended use, matrix, and performance to the Microgenics's Drugs of Abuse Urine Calibrators and Controls, and Dade Behring Multianslyte Calibrators and Controls.

all spiked values of calibrators and controls were confirmed with GC/MS. Performance characteristics on precision, accuracy and stability are acceptable.

## Conclusion

The information provided in the premarket notification demonstrates that the LZI's urine Multi-Analyte Drugs of Abuse Calibrators and Controls are safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

JUN 2 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cheng-I Lin, Ph.D. President Lin-Zhi International, Inc. 687 North Pastoria Ave. Sunnyvale, CA 94085

k051088 Re:

K051000
Trade/Device Name: Multiple Analyte Urine Calibrators and Controls Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB, DIF Dated: April 26, 2005 Received: April 28, 2005

Dear Dr. Lin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premium is substantially equivalent (for the indications felerenced above and nave acterimined by marketed predicate devices marketed in interstate for use stated in the encrosule) to tegans actment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Forley of Dr commerce prior to May 20, 1970, the excordance with the provisions of the Federal Food, Drug, devices mat have been rechasified in asse e approval of a premarket approval application (PMA). and Costinetic Act (11ct) that do not request to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rice labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 acove) inrols. Existing major regulations affecting your device it may be subject to such additions comes of the result to 895. In addition, FDA can be found in This 21, Occaments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri- 5 issuance or a cadevice complies with other requirements of the Act that IDA has made a acternations administered by other Federal agencies. You must br any I cochar statutes and regulations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice erequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms icter will anow you to organ maing of substantial equivalence of your device to a legally premarket notification: "The PDs in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, r you destre specific inte motion and advertising of your device, please contact the Office of In of quostions on the promotion and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the Tou may other general mistmannianal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Premarket Notification

## Indications for Use Statement

# 510(k) Number (if known): _ KOS 1088

## Device Name: Multiple Analyte Urine Calibrators and Controls

#### Indications for Use:

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine.

The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine.

*(Division Sign-Off)*

Division of Clinical Laboratory Devices
510(k) Number K051688

> Prescription Use AND/OR (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)