OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS

K050733 · Lin-Zhi International, Inc. · DJG · Jun 13, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050733
• Device Name: OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
• Applicant: Lin-Zhi International, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jun 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 and 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of oxycodone and its metabolite in human urine. The LZI Oxycodone Enzyme Immunoassay 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

Ready-to-use liquid reagent homogeneous enzyme immunoassay; detects oxycodone and oxymorphone in human urine. Principle: competition between G6PDH-labeled oxycodone derivative and free drug in sample for fixed antibody; binding of antibody to labeled drug decreases enzyme activity. Enzyme activity measured spectrophotometrically at 340 nm via NAD to NADH conversion. Used on automated clinical chemistry analyzers (e.g., Hitachi 717) in clinical laboratory settings. Provides preliminary screening results; requires confirmatory testing via GC/MS. Clinical decision-making relies on professional judgment of preliminary results. Benefits include rapid, simple screening for drug-of-abuse testing.

Clinical Evidence

Bench testing only. Performance evaluated using clinical urine specimens (n=59 to 112 depending on protocol). Compared against predicate device and GC/MS. Qualitative and semi-quantitative agreement with GC/MS ranged from 88.1% to 100%. Precision evaluated over 10 days (n=120 per sample) on Hitachi 717 analyzer; total CVs generally <3%. Analytical sensitivity (LOD) determined as 7.5 ng/mL (100 ng/mL cutoff) and 15 ng/mL (300 ng/mL cutoff).

Technological Characteristics

Homogeneous enzyme immunoassay; liquid reagent. Sensing principle: spectrophotometric measurement of G6PDH enzyme activity at 340 nm. Storage: 2°C to 8°C. Compatible with automated clinical chemistry analyzers.

Indications for Use

Indicated for qualitative and semi-quantitative analysis of oxycodone and its metabolite (oxymorphone) in human urine. Used as a preliminary analytical screening procedure. Requires confirmation by alternative chemical methods (e.g., GC/MS).

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• DRI® Oxycodone Assay (K040411)

Submission Summary (Full Text)

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050733

# 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. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: [phone] Fax: [phone]

Cheng-I Lin, Ph.D. Contact: President, R&D Director

# Device Name and Classification

| Classification Name: Enzyme Immunoassay, Opiate<br>Class II, DJG (91 Toxicology),<br>21CFR 862.3650 |
|-----------------------------------------------------------------------------------------------------|
| Oxycodone calibrators,<br>Class II, DLJ, (91 Toxicology),<br>21CFR 862.3200 |

Oxycodone controls, Class I, LAS (91 Toxicology), 21CFR 862.3280

| Common Name: | Homogeneous Oxycodone Enzyme Immunoassay |
|-------------------|------------------------------------------|
| Proprietary Name: | LZI Oxycodone Assay |

### Legally Marketed Predicate Device(s)

The LZI Oxycodone Enzyme Immunoassay is substantially equivalent to the DRI® Oxycodone Assay (K040411) manufactured by DRI/Microgenics Corp.

LZI's Oxycodone Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.

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# Device Description

LZI's Oxycodone Enzyme Immunoassay is a ready-to-use liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect oxycodone and oxymophone in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.

The assay is based on competition between oxycodone derivative labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme and free drug from sample for a fixed amount of specific antibody. In the absence of free drug from the sample, the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 mm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.

# Intended Use

The LZI Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 and 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of oxycodone and its metabolite in human urine. The LZI Oxycodone Enzyme Immunoassay 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.

# Comparison to Predicate Device

LZI's Oxycodone Enzyme Immunoassay is substantially equivalent to the product in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed DRI® Oxycodone Assay (K040411) by Microgenics Corporation.

The following table compares LZI's Oxycodone Enzyme Immunoassay with the predicate device, DRI Oxycodone Enzyme Immunoassay by Microgenics Corp.

Similarities:

- Both assays are for qualitative and semi-quantitative determination of oxycodone . and its metabolite in human urine.
- Both are ready-to-use liquid reagents. .
- Both have 100 and 300 ng/mL cutoffs. .
- Both assays use the same method principle, and device components. .
- Both stored at 2℃ to 8℃ until expiration date. .

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#### Differences:

- DRI assay uses 5 points calibration (0, 100, 300, 500, 1000 ng/ml) for semi-. quantitative determination. LZI assay uses three different calibrator/control sets (0, 75, 100, 225, and 300 ng/mL) (0, 100, 300, 500 and 800 ng/mL) for semiquantitative determination.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### JUN 1 3 2005

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

Re: k050733

Trade/Device Name: Oxycodone Enzyme Immunoassay and Oxyodone Calibrators and Controls Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DLJ, LAS Dated: May 20, 2005 Received: May 24, 2005

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) This icter will anow you to oogin manteenig your device of your device to a legally premarket notification: - The PDT Intactig sification 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, If you desire specific infortion and advertising of your device, please contact the Office of In of questions on the premier Evaluation and Safety at [phone]. Also, please note the v mo Diagnostic Develop Branding by reference to premarket notification" (21CFR Part 807.97). regulation ontaou, "Thiordians" of stimment on your responsibilities under the Act from the I va may other 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,

Carol C. Benem

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): __ K050733

# Device Name: Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls.

# Indications for Use:

The Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 The Oxyodone Enzynie Intended for use in the qualitative and semi-qualitative and semi-quantitative and 500 ing mill outone and its metabolite, oxymorphone in human urine.

analyses of Uxyoodone ans are used to calibrate the oxycodone enzyme immunoassay for I he Oxyoodone canorators are The Oxycodone controls are used to validate the assay. the assay provides a simple and rapid analytical screening procedure to detect oxycodone and its metabolite in human urine.

allo its nictaoonie in haman anner of automated clinical chemated clinical chemistry analyzers. Performance data submitted was obtained using the Hitachi 717 analyzer. analyzers: Forformance ammunoassay provides only a preliminary analytical test result. A The Oxyoodene Lingine chemical method must be used to obtain a confirmed analytical more specific atchiatry of themass 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.

V Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

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

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

Qute a Chele (Per 21 CFR 801.109)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) k050733