OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS

K050988 · Lin-Zhi International, Inc. · DLG · Apr 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K050988
• Device Name: OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
• Applicant: Lin-Zhi International, Inc.
• Product Code: DLG · Clinical Chemistry
• Decision Date: Apr 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2250
• Device Class: Class 1

Intended Use

The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte Morphine are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Device Story

Liquid reagent homogeneous enzyme immunoassay; detects opiates in human saliva. Principle: competition between G6PDH-labeled drug and free drug in saliva sample for fixed antibody binding sites; absence of free drug allows antibody to bind labeled enzyme, decreasing activity. Enzyme activity measured spectrophotometrically at 340 nm via conversion of NAD to NADH; drug concentration proportional to enzyme activity. Used in clinical laboratories; operated by professional staff on automated clinical chemistry analyzers. Provides preliminary qualitative results; requires GC/MS confirmation. Assists clinicians in drug-of-abuse screening.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing of assay performance, including sensitivity, specificity, and cross-reactivity profiles.

Technological Characteristics

Homogeneous enzyme immunoassay; liquid reagents (antibody/substrate and enzyme/drug conjugate). Sensing principle: competitive binding measured via absorbance change at 340 nm. Requires automated clinical analyzer (Roche Hitachi 717). Calibrators/controls based on oral fluid buffer. Stability: 18 months at 2-8°C.

Indications for Use

Indicated for the qualitative detection of opiates in human saliva specimens collected via Salivette collector for professional use in clinical chemistry laboratories. Not for point-of-care settings.

Regulatory Classification

Identification

A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.

Predicate Devices

• Opiates Intercept® Micro-plate EIA (K981341)

Submission Summary (Full Text)

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K050988

# 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

March 24, 2006

Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: [phone] [phone] Fax:

Contact: Marie Lin, Ph.D. President, R&D Director

#### Device Name and Classification

| Classification Name: | The Opiate test system has been placed in Class II by the Bureau of Medical Devices. Classification Number: DJG (21 CFR 862.3650) Panel: 91 Toxicology |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The “Drug Specific, Calibrators” has been placed in Class II by the Bureau of Medical Devices. Classification No.: DLJ, 21 CFR 862.3200 Panel: 91 Toxicology |
| | The “Single (Specified) Analyte Controls” has been placed in Class I by the Bureau of Medical Devices. Classification No.: LAS, 21 CFR 862.3280 Panel: 91 Toxicology |
| Common Name: | Opiate Oral Fluid Homogeneous Enzyme Immunoassays |
| Proprietary Name: | None |

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## Predicate Device(s)

The LZI Opiate Oral Fluid Enzyme Immunoassay is substantially equivalent to the Opiates Intercept® Micro-plate EIA (K981341) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use.

## Device Description

LZI's Oral Fluid Opiate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Opiate in oral fluid with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the saliva sample for a fixed amount of specific antibody. In the absence of free drug from the saliva sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.

### Intended Use

The Opiate Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect Opiate in human saliya with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt ) and diluted with 1 mL of buffer. The calibrators and controls of the analyte (Morphine) are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for Opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.

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## Comparison to Predicate Device

The LZI Opiate Oral Fluid Homogeneous Enzyme Immunoassay, including calibrators and controls, is substantially equivalent to OraSure's Opiates Intercept® Micro-plate EIA in its intended use and in for the qualitative determination of opiates in human oral fluid.

| Device<br>Characteristics | Subject Device<br>(LZI Opiate Oral Fluid Homogeneous<br>EIA) | Predicate Device<br>(OraSure Opiate Intercept® Micro-<br>plate EIA) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LZI Opiate Oral Fluid<br>Homogeneous EIA is a homogeneous<br>enzyme immunoassay system to detect<br>opiates in human saliva with a cutoff of<br>30 ng/mL when testing oral fluid<br>specimen collected with Salivette<br>collector (manufactured by Sarstedt )<br>and diluted with 1 mL of buffer. The<br>calibrators and controls of the analyte<br>(Opiate) are prepared with oral fluid<br>buffer so that it can be used to verify<br>and validate the assay. The assay is<br>intended for use in the qualitative<br>determination for Opiate drugs.<br><br>The Opiate Oral Fluid Enzyme<br>Immunoassay is a homogeneous<br>enzyme immunoassay system provides<br>only a preliminary analytical test<br>result. A more specific alternative<br>chemical method must be used to<br>obtain a confirmed analytical result.<br>Gas chromatography/mass<br>spectrometry (GC/MS) is the preferred<br>confirmatory method. Clinical<br>consideration and professional<br>judgment should be applied to any<br>drug-of-abuse test result, particularly<br>when preliminary positive results are<br>used. | The OraSure Opiate Intercept®<br>Micro-plate EIA is intended for use by<br>clinical laboratories in the qualitative<br>determination of opiates in oral fluid<br>collected with Intercept® DOA Oral<br>Specimen Collection Device using a<br>10 ng/mL cutoff. For <i>In Vitro</i><br>Diagnostic Use.<br><br>The OraSure Opiate Intercept®<br>Micro-plate EIA provides only a<br>preliminary analytical test result. A<br>more specific alternative chemical<br>method should be used in order to<br>obtain a confirmed analytical result.<br>Gas chromatography/mass<br>spectrometry (GC/MS) is the<br>preferred confirmatory method.<br>Clinical consideration and<br>professional judgement should be<br>applied to any drugs of abuse test<br>result, particularly when a<br>preliminary, positive result is<br>observed. |
| Analyte | Morphine | Morphine |
| Matrix | Saliva | Saliva |
| Calibrators/<br>Controls Level | 5 levels including a negative | 4 levels including a negative |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird symbol in the center. The text around the perimeter reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird symbol in the center is composed of three curved lines that form the shape of a bird in flight.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

6 2006 APR

Marie Lin, Ph.D. President Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085-2917

Re: k050988

Trade/Device Name: LZI Oral Fluid Opiate Enzyme Immunoassay. Calibrators and Controls Regulation Number: 21 CFR§862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DLJ, LAS Dated: March 24, 2006 Received: March 28, 2006

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 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. 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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# Indications for Use

510(k) Number (if known): k050988

Device Name: LZI Oral Fluid Opiate Enzyme Immunoassay, Calibrators and Controls.

Indications For Use:

The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte Morphine are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Division Sign-Off

Office of In Vitro Dinanostic Device Evaluation and Safety

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