LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS

K133710 · Lin-Zhi International, Inc. · DKB · Feb 21, 2014 · Clinical Toxicology

Device Facts

• Record ID: K133710
• Device Name: LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
• Applicant: Lin-Zhi International, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Feb 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The LZI Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepam, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers. The LZI Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepam, and Secobarbital. The controls are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.

Device Story

Device consists of liquid, ready-to-use calibrators and controls for drugs of abuse testing. Input: processed, drug-free human urine matrix spiked with known concentrations of specific drug analytes. Operation: used by laboratory technicians on automated clinical chemistry analyzers to calibrate assays and monitor performance. Output: calibration curves and quality control results used by clinicians to verify assay accuracy. Clinical context: preliminary analytical results; requires confirmation by GC/MS or LC/MS. Benefit: ensures accuracy and reliability of drug screening assays, supporting clinical decision-making in toxicology.

Clinical Evidence

Bench testing only. Stability studies conducted at 2-8°C, room temperature, and 30°C; results showed <10% variation. Real-time stability confirmed for at least 12 months at 2-8°C. Value assignment verified gravimetrically using NIST-traceable weights and confirmed by GC/MS to be within ±10% of target concentrations.

Technological Characteristics

Liquid, ready-to-use human urine matrix containing drug analytes and 0.09% sodium azide preservative. Analyte concentrations verified by GC/MS. Storage at 2-8°C. Compatible with automated clinical chemistry analyzers using homogeneous enzyme immunoassay technology.

Indications for Use

Indicated for in vitro diagnostic calibration and performance monitoring of homogeneous enzyme immunoassays for drugs of abuse (Benzoylecgonine, Methamphetamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepam, Secobarbital) in human urine. For prescription use on automated clinical chemistry analyzers.

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.

Submission Summary (Full Text)

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# FEB 2 1 2014

## k133,710

# 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. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: [phone] Fax: [phone] · e-mail: [e-mail]

Contact: Bernice Lin. Ph.D. VP Operations

#### Submission Date

February 21, 2014

#### Multi-calibrator Set A, B, and C Device Name and Classification

Multi-calibrator Set A:

| Classification Name: | Drug Mixture Calibrator Materials<br>Class II, DKB (91 Toxicology)<br>21 CFR862.3200 |
|-------------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Benzoylecgonine, Methamphetamine, Methadone, and 6-<br>acetylmorphine Calibrators |
| Proprietary Name: | LZI Multiple Analyte Set A Drugs of Abuse Calibrators |
| Classification Name: | Drug Mixture Control Materials<br>Class I, DIF (91 Toxicology),<br>21 CFR 862.3280 |
| Common Name: | Benzoylecgonine, Methamphetamine, Methadone, and 6-<br>acetylmorphine Controls |
| Proprietary Name: | LZI Multiple Analyte Set A Drugs of Abuse Controls<br>Page 1 of 9 |
| Classification Name: | Drug Mixture Calibrator Materials<br>Class II, DKB (91 Toxicology),<br>21 CFR862.3200 |
| Common Name: | MDMA, Morphine, Oxazepam, and Secobarbital Calibrators |
| Proprietary Name: | LZI Multiple Analyte Set B Drugs of Abuse Calibrators |
| Classification Name: | Drug Mixture Control Materials<br>Class I, DIF (91 Toxicology),<br>21 CFR 862.3280 |
| Common Name: | MDMA, Morphine, Oxazepam, and Secobarbital Controls |
| Proprietary Name: | LZI Multiple Analyte Set B Drugs of Abuse Controls |
| Multi-calibrator Set C: | |
| Classification Name: | Drug Mixture Calibrator Materials<br>Class II, DKB (91 Toxicology),<br>21 CFR862.3200 |
| Common Name: | Benzoylecgonine, Methamphetamine, Methadone, Morphine,<br>Oxazepam, and Secobarbital Calibrators |
| Proprietary Name: | LZI Multiple Analyte Set C Drugs of Abuse Calibrators |
| Classification Name: | Drug Mixture Control Materials<br>Class I, DIF (91 Toxicology),<br>21 CFR 862.3280 |
| Common Name: | Benzoylecgonine, Methamphetamine, Methadone, Morphine,<br>Oxazepam, and Secobarbital Controls |
| Proprietary Name: | LZI Multiple Analyte Set C Drugs of Abuse Controls |

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# Multi-calibrator Set B:

# Previous Submission Information

There were no prior submissions for this subject device (k133710).

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## Legally Marketed Predicate Device(s)

The LZI Multiple Analyte Set A. B. and C Drugs of Abusc Calibrators and Controls (k133710) are substantially equivalent to the Multiple Analyte Drugs of Abuse Calibrators and Controls (k051088) manufactured by Lin-Zhi International, Inc. The LZI Multiple Analyte Set A. B. and C Drugs of Abuse Calibrators and Controls are identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance. ·

#### Device Description

All of the LZI Multiple Analyte Set A, B, and C Drugs of Abuse 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 in human urine with sodium azide (0.09%) as preservative. 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. These five calibrators and two controls are sold as individual bottles. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:

| | Low<br>Calibrator<br>ng/mL | Cutoff<br>Calibrator<br>ng/mL | Intermediate<br>Calibrator<br>ng/mL | High<br>Calibrator<br>ng/mL | Control<br>Level 1<br>ng/mL | Control<br>Level 2<br>ng/mL |
|-------------------|----------------------------|-------------------------------|-------------------------------------|-----------------------------|-----------------------------|-----------------------------|
| Material | | | | | | |
| Benzoylecgonine | 75 | 150 | 300 | 1000 | 112.5 | 187.5 |
| d-Methamphetamine | 250 | 500 | 750 | 1000 | 375 | 625 |
| Methadone | 150 | 300 | 600 | 1000 | 225 | 375 |
| 6-AM | 5 | 10 | 20 | 40 | 7.5 | 12.5 |

Table 1: LZI Multiple Analyte Set A Calibrators and Controls:

* 5" Calibrator is the Negative Calibrator

Table 2: LZI Multiple Analyte Set B Calibrators and Controls:

| | 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 |
| MDMA | 250 | 500 | 750 | 1000 | 375 | 625 |
| Morphine | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Oxazepam | 100 | 200 | 500 | 1000 | 150 | 250 |
| Secobarbital | 100 | 200 | 500 | 1000 | 150 | 250 |

* 5th Calibrator is the Negative Calibrator

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| | 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 |
| Benzoylecgonine | 75 | 150 | 300 | 1000 | 112.5 | 187.5 |
| d-Methamphetamine | 250 | 500 | 750 | 1000 | 375 | 625 |
| Methadone | 150 | 300 | 600 | 1000 | 225 | 375 |
| Morphine | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Oxazepam | 100 | 200 | 500 | 1000 | 150 | 250 |
| Secobarbital | 100 | 200 | 500 | 1000 | 150 | 250 |

## Table 3: LZI Multiple Analyte Set C Calibrators and Controls:

* 5th Calibrator is the Negative Calibrator

·

.

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## Intended Use

Device Name: LZI Multiple Analyte Set A, B, and C Urine Drugs of Abusc Calibrators

The LZI Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of assavs for the analytes currently listed in the package insert: Benzovlecgonine. Methamphetamine, Methadone. 6-acetylmorphine, MDMA, Morphine. Oxazepam, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassavs on automated clinical chemistry analyzers.

Device Name: LZI Multiple Analyte Set A. B. and C Urine Drugs of Abuse Controls

The LZI Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzovlecgonine. Methamphetamine. Methadone. 6-acctylmorphine. MDMA, Morphine, Oxazepam, and Secobarbital. The controls are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.

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The LZI Multiple Set A, B, and C Dnies of Abuse Calibralors and Control (List Miller Andent (o them (o them (o them (o the 1) in the Ander (o the Milital )
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| Device<br>Characteristics | Subject Device<br>(k133710)<br>LZI Multiple Analyte<br>Set A<br>DAU Calibrators and Controls | Subject Device<br>(k133710)<br>LZI Multiple Analyte<br>Set B<br>DAU Calibrators and Controls | Subject Device<br>(k133710)<br>LZI Multiple Analyte<br>Set C<br>DAU Calibrators and Controls | Predicate Device<br>(k051088)<br>LZI Multiple Analyte DAU<br>Calibrators and Controls |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for in vitro diagnostic<br>use for the calibration and<br>validation of LZI DAU enzyme<br>immunoassays to detect<br>benzoylecgonine,<br>methamphetamine, methadone,<br>and 6-acetylmorphine, in<br>human urine.<br><br>The assays used with the multiple<br>analyte calibrators and controls only<br>provide a preliminary analytical result.<br>A more specific alternative chemical<br>method must be used in order to obtain<br>a confirmed analytical result. Gas or<br>liquid chromatography/mass<br>spectrometry (GC/MS or LC/MS) is<br>the preferred confirmatory method.<br>Clinical consideration and<br>professional judgment should be<br>exercised with any drug of abuse test<br>result, particularly when the | Intended for in vitro diagnostic<br>use for the calibration and<br>validation of LZI DAU enzyme<br>immunoassays to detect<br>MDMA, morphine, oxazepam,<br>and secobarbital in human<br>urine.<br><br>The assays used with the multiple<br>analyte calibrators and controls only<br>provide a preliminary analytical result.<br>A more specific alternative chemical<br>method must be used in order to obtain<br>a confirmed analytical result. Gas or<br>liquid chromatography/mass<br>spectrometry (GC/MS or LC/MS) is<br>the preferred confirmatory method.<br>Clinical consideration and<br>professional judgment should be<br>exercised with any drug of abuse test<br>result, particularly when the<br>preliminary test result is positive. | Intended for in vitro diagnostic<br>use for the calibration and<br>validation of LZI DAU enzyme<br>immunoassays to detect<br>benzoylecgonine,<br>methamphetamine, methadone,<br>morphine, oxazepam, and<br>secobarbital in human urine.<br><br>The assays used with the multiple<br>analyte calibrators and controls only<br>provide a preliminary analytical result.<br>A more specific alternative chemical<br>method must be used in order to obtain<br>a confirmed analytical result. Gas or<br>liquid chromatography/mass<br>spectrometry (GC/MS or LC/MS) is<br>the preferred confirmatory method.<br>Clinical consideration and<br>professional judgment should be<br>exercised with any drug of abuse test<br>result, particularly when the | Intended for in vitro diagnostic<br>use for the calibration and<br>validation of LZI DAU enzyme<br>immunoassays to detect<br>methamphetamine, opiate,<br>phencyclidine,<br>benzoylecgonine,<br>benzodiazepines, barbiturates,<br>methadone, and propoxyphene<br>in human urine. |

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| Device<br>Characteristics | Subject Device<br>(k133710)<br>LZI Multiple Analyte<br>Set A<br>DAU Calibrators and Controls | Subject Device<br>(k133710)<br>LZI Multiple Analyte<br>Set B<br>DAU Calibrators and Controls | Subject Device<br>(k133710)<br>LZI Multiple Analyte<br>Set C<br>DAU Calibrators and Controls | Predicate Device<br>(k051088)<br>LZI Multiple Analyte DAU<br>Calibrators and Controls | | Low<br>Calibrator | Cutoff<br>Calibrator | Intermediate<br>Calibrator | High<br>Calibrator | Control<br>Level 1 | Control<br>Level 2 |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------|-------------------|----------------------|----------------------------|--------------------|--------------------|--------------------|
| Analyte | benzoylecgonine,<br>d-methamphetamine,<br>methadone,<br>6-acetylmorphine | morphine,<br>oxazepam,<br>secobarbital,<br>MDMA | benzoylecgonine<br>d-methamphetamine,<br>methadone,<br>morphine,<br>oxazepam,<br>secobarbital | benzoylecgonine,<br>d-methamphetamine,<br>methadone,<br>morphine,<br>oxazepam,<br>secobarbital,<br>phencyclidine,<br>propoxyphene | ng/mL | 250 | 500 | 750 | 1000 | 375 | 625 |
| Materials are<br>applicable for assays<br>with the cutoff<br>concentrations listed<br>(ng/mL) | COC - 150<br>MAMP or AMP - 500<br>MTD - 300<br>6AM - 10 | OPI - 2,000<br>BZO - 200<br>BARB - 200<br>MDMA - 500 | COC - 150<br>MAMP or AMP - 500<br>MTD - 300<br>OPI - 2,000<br>BZO - 200<br>BARB - 200 | COC - 150<br>MAMP or AMP - 500<br>MTD - 300<br>OPI - 2,000<br>BZO - 200<br>BARB - 200<br>PCP - 25<br>PPX - 300 | ng/mL | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Matrix | Urine | Urine | Urine | Urine | | | | | | | |
| Calibrators Level | 5 Levels - See Table 1<br>(under "Device<br>Description") | 5 Levels - See Table 2<br>(under "Device<br>Description") | 5 Levels - See Table 3<br>(under "Device<br>Description") | 5 Levels - See Table 4<br>(below) | | | | | | | |
| Controls Level | 2 Levels - See Table 1<br>(under "Device<br>Description") | 2 Levels - See Table 2<br>(under "Device<br>Description") | 2 Levels - See Table 3<br>(under "Device<br>Description") | 2 Levels - See Table 4<br>(below) | | | | | | | |
| Storage | 2-8 °C until expiration<br>date | 2-8 °C until expiration<br>date | 2-8 °C until expiration<br>date | 2-8 °C until expiration<br>date | | | | | | | |

Comparison to Predicate Device (continued

Page 7 of 9

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:

Table 4: Predicate Multiple Analyte Calibrators and Controls (k051088)

5" Calibrator is the Negative Calibrator

,

.

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# Performance Characteristics Summary:

## Multiple Analyte Sets A,B, and C Drugs of Abuse Calibrators and Controls Stability:

Based on the largest % change for any individual concentration or % change in Total Separation (versus Day 0 measurements) at Cold (2-8 ℃), Room Temperature, and Accelerated (30 ℃) Temperature sudies, the LZ1 Multiple Analyte Set A. B. and C Drugs of Abuse Calibrators and Controls did not vary greater than ±10%. In Set A. the only analyte for which this differed was the 6- acetylmorphine (6AM) Calibrator and Control. In Set B and C. the only analyte for which this differed was the Benzodiazeoine (Oxazepam) Calibrator and Control. All calibrators and controls held steady when stored at 2 ℃ to 8 ℃ (refrigerated) up to Day 366 real time. Based on these data we have capped our predicted shelf-life to the current cold temperature real-time study for the LZI Multiple Analyte Sets A. B. and C Drugs of Abuse Calibrators and Controls to at least 12 months.

## Traceability and Value Assignment:

The starting materials for the calibrators and controls were commercially available standard stock solutions in methanol. The standard solution was found to be 99% in purity, analvzed by GC/MS, Secondary stock solutions were prepared using negative urine calibrator matrix and the concentrations were verified gravimetrically using balances calibrated with NIST traceable weights. The secondary stock solutions were then spiked into the negative urine calibrator matrix to the desired concentration and verified by GC/MS to be within ± 10% of the uarget concentration.

#### Summary:

The information provided in this pre-market notification demonstrates that the LZJ Multiple Analyte Sets A. B. and C Drugs of Abuse Calibrators and Controls are substantially equivalent to the legally marketed predicate device for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by gas chromatography/mass spectrometry (GC/MS), an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Multiple Analyte Sets A, B, and C Drugs of Abuse Calibrators and Controls are safe and cflective for its stated intended use.

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Image /page/9/Picture/0 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 and body. The eagle is enclosed in a circle of text that reads "Department of Health & Human Services USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO64-(isa) Silver Spong, MI) 20043-00002

February 21, 2014

LIN-ZHI INTERNATIONAL, INC. BERNICE LIN, PH.D. VP OPERATIONS 670 ALMANOR AVE SUNNYVALE CA 94085

Received: December 4, 2013

Re: K133710

Trade/Device Name: Lin-Zhi Multiple Analyte Set A. B and C Urine Drugs of Abuse Calibrators Lin-Zhi Multiple Analyte Set A. B and C Urine Drugs of Abuse Controls Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: II Product Code: DKB, DIF Dated: December 2, 2013

Dear Dr. Lin:

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 dute 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. Please note: CDRH does not evaluate information related to contract fiability warranties. We remind you, however, that device labeling must be truthful and not misleading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 Parts 801 and 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the

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Page 2-Ms Lin

electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 80) and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part -807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 805), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address hup://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

# Ruth A. Chesler -S

#### lior

Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) k133710

#### Device Name

Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Callbrators; Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls

Indications for Use (Describe)

The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in viro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphelamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepan, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.

The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphelamine, Methadone, 6-acetylmorphine, Oxazepan, and Secobarbital. The controls are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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