LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS

Q: Who is the manufacturer of LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS?

Lin-Zhi International, Inc. filed the 510(k) submission for LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS (K120763).

Q: What is the FDA product code for LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS?

DJG. It is classified under 21 CFR 862.3650 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS?

LZI Oxycodone Enzyme Immunoassay (k050733).

Q: Who can help prepare an FDA 510(k) submission like LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K120763 · Lin-Zhi International, Inc. · DJG · Jun 1, 2012 · Clinical Toxicology

Device Facts

Record ID	K120763
Device Name	LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
Applicant	Lin-Zhi International, Inc.
Product Code	DJG · Clinical Toxicology
Decision Date	Jun 1, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3650
Device Class	Class 2

Intended Use

The LZI Oxycodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of Oxycodone in human urine at the cutoff values of 100 and 300 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures. The LZI Oxycodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oxycodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL. The LZI Oxycodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Oxycodone Enzyme Immunoassay at the cutoff value of 100 and 300 ng/mL. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Device Story

Homogeneous enzyme immunoassay for detection of oxycodone in human urine; utilizes competitive binding between drug in sample and G6PDH-labeled drug for fixed antibody amount. Enzyme activity inversely proportional to drug concentration; active enzyme converts NAD to NADH, measured spectrophotometrically at 340 nm. Used in clinical laboratories on automated chemistry analyzers (e.g., Hitachi 717) by trained technicians. Provides preliminary screening results; requires confirmation by GC/MS or LC/MS. Assists clinicians in identifying potential drug presence for further diagnostic or forensic evaluation.

Clinical Evidence

Bench testing only. Precision evaluated using 88 determinations per concentration level. Method comparison performed on 89 clinical samples (100 ng/mL cutoff) and 101 clinical samples (300 ng/mL cutoff) against GC/MS or LC/MS. 100 ng/mL cutoff showed 93.75% positive agreement and 100% negative agreement. 300 ng/mL cutoff showed 96.1% positive agreement and 98.0% negative agreement. Linearity (0-800 ng/mL) confirmed with r2 = 0.998.

Technological Characteristics

Homogeneous enzyme immunoassay; reagents include mouse monoclonal anti-oxycodone antibody, G6PDH-labeled oxycodone, G6P, NAD, and sodium azide preservative. Spectrophotometric detection at 340 nm. Designed for automated clinical chemistry analyzers. Storage at 2-8 °C.

Indications for Use

Indicated for qualitative and semiquantitative determination of Oxycodone in human urine at 100 and 300 ng/mL cutoffs. For professional use in clinical laboratories. No specific age or gender restrictions.

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

LZI Oxycodone Enzyme Immunoassay (k050733)

Related Devices

K050733 — OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS · Lin-Zhi International, Inc. · Jun 13, 2005
K131168 — IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY · Immunalysis Corporation · Jan 17, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ # 120763 #### CONFIDENTIAL ## JUN - 1 2012 Lin-Zhi International, Inc. ... ## 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: (408) 732-3856 Fax: (408) 732-3849 e-mail: bclin@lin-zhi.com Contact: Bernice Lin. Ph.D. VP Operations #### Device Name and Classification Classification Name: Enzyme Immunoassay, Oxycodone Class II, DJG (91 Toxicology), 21 CFR 862.3650 Drug Specific Calibrators, Class II, DLJ (91 Toxicology), 21 CFR 862.3200 Drug Specific Controls, Class I, LAS (91 Toxicology), 21 CFR 862.3280 Common Name: Proprietary Name: Homogeneous Oxycodone Enzyme Immunoassay LZI Oxycodone Enzyme Immunoassay, LZI Oxycodone Drugs of Abuse (DAU) Calibrators LZI Oxycodone Drugs of Abuse (DAU) Controls {1}------------------------------------------------ #### CONFIDENTIAL ### Legally Marketed Predicate Device(s) The LZI Oxycodone Enzyme Immunoassay (EIA) is substantially equivalent to the Lin-Zhi International, Inc. Oxycodone Enzyme Immunoassay (k050733) manufactured by Lin-Zhi International, Inc. The LZI Oxycodone Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance. #### Device Description The LZI Oxycodone assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, oxycodone-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound oxycodone-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm. The LZI Oxycodone Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2, which are bottled separately but sold together within the kit. The R. solution contains mouse monoclonal anti-Oxycodone antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with oxycodone in buffer with sodium azide (0.09%) as preservative. The LZI Oxycodone Enzyme Immunoassay (k050733) calibrators and controls designated for use at the 100 and 300 ng/mL cutoffs contain 0, 50, 75, 100, 125, 225, 300, 375, 500, and 800 ng/mL of oxycodone in human urine with sodium azide (0.09%) as preservative. These six calibrators and four controls are sold as individual bottles. {2}------------------------------------------------ #### CONFIDENTIAL Lin-Zhi International, Inc. #### Intended Use The LZI Oxycodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of Oxycodone in human urine at the cutoff values of 100 and 300 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures. The LZI Oxycodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oxycodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL. The LZI Oxycodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Oxycodone Enzyme Immunoassay at the cutoff value of 100 and 300 ng/mL. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. {3}------------------------------------------------ ## CONFIDENTIAL ## Comparison to Predicate Device The LZI Oxycodone Enzyme Immunoassay is substantially equivalent to the Lin-Zhi International, Inc. Oxycodone Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification k050733 for its stated intended use. The following table compares LZI's Oxycodone Enzyme Immunoassay with the predicate device. | Device Characteristics | Subject Device LZI Oxycodone Enzyme Immunoassay, Calibrators and Controls | Predicate Device (k050733) LZI Oxycodone Enzyme Immunoassay, Calibrators and Controls | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The LZI Oxycodone Enzyme Immunoassay, when used in conjunction with Hitachi 717 automated clinical system analyzers, is intended for the qualitative and semi-quantitative determination of oxycodone and oxymorphone in human urine at cutoff values of 100 or 300 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. | The LZI Oxycodone Enzyme Immunoassay, when used in conjunction with Hitachi 717 automated clinical system analyzers, is intended for the qualitative and semi-quantitative determination of oxycodone and oxymorphone in human urine at cutoff values of 100 or 300 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. | | | This assay provides a rapid screening procedure for determining the presence of oxycodone and oxymorphone in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. | This assay provides a rapid screening procedure for determining the presence of oxycodone and oxymorphone in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. | | Analyte | Oxycodone | Oxycodone | | Cutoff | 100 or 300 ng/ml | 100 or 300 ng/mL | | Matrix | Urine | Urine | | Calibrators Level | 0, 50, 100, 300, 500, and 800 ng/mL | 100 ng/mL Cutoff: 5 Levels (0, 75, 100, 225, 300 ng/mL) 300 ng/mL Cutoff: 5 Levels (0, 100, 300, 500, 800 ng/mL) | | Controls Level | 100 ng/mL Cutoff: 2 Levels (75 ng/mL, 125 ng/mL) 300 ng/mL Cutoff: 2 Levels (225 ng/mL, 375 ng/mL) | 100 ng/mL Cutoff: 2 Levels (75 ng/mL, 125 ng/mL) 300 ng/mL Cutoff: 2 Levels (225 ng/mL, 375 ng/mL) | | Storage | 2-8 °C until expiration date | 2-8 °C until expiration date | {4}------------------------------------------------ ## Performance Characteristics Summary: 100 ng/mL Cutoff Hitachi 717 Analyzer ## Precision: 100 ng/mL Cutoff Semi-Quantitative Positive/Negative Results: | 100 ng/mL Cutoff Result: | | Within Run | | Total Precision | | |--------------------------|-------------|----------------------------|-----------------------|----------------------------|-----------------------| | Sample Concentration | % of Cutoff | Number of Determination | Immunoassay Result | Number of Determination | Immunoassay Result | | 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative | | 25 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative | | 50 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative | | 75 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative | | 100 ng/mL | 100.0% | 22 | 9 Pos/13 Neg | 88 | 39 Pos/49 Neg | | 125 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive | | 150 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive | | 175 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive | | 200 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive | ## Qualitative Positive/Negative Results: | 100 ng/mL Cutoff Result: | | Within Run | | Total Precision | | |--------------------------|-------------|----------------------------|-----------------------|----------------------------|-----------------------| | Sample Concentration | % of Cutoff | Number of Determination | Immunoassay Result | Number of Determination | Immunoassay Result | | 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative | | 25 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative | | 50 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative | | 75 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative | | 100 ng/mL | 100.0% | 22 | 6 Pos/ 16 Neg | 88 | 25 Pos/63 Neg | | 125 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive | | 150 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive | | 175 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive | | 200 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive | ## Precision: 300 ng/mL Cutoff Semi-Quantitative Positive/Negative Results: | 300 ng/mL Cutoff Result: | | Within Run | | Total Precision | | |--------------------------|-------------|----------------------------|-----------------------|----------------------------|-----------------------| | Sample Concentration | % of Cutoff | Number of Determination | Immunoassay Result | Number of Determination | Immunoassay Result | | 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative | | 75 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative | | 150 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative | | 225 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative | | 300 ng/mL | 100.0% | 22 | 3 Pos/ 19 Neg | 88 | 26 Pos/ 62 Neg | | 375 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive | | 450 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive | | 525 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive | | 600 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive | {5}------------------------------------------------ #### Precision: 300 ng/mL Cutoff Continued Oualitative Positive/Negative Results: | 300 ng/mL Cutoff Result: | | Within Run | | Total Precision | | |--------------------------|-------------|----------------------------|-----------------------|----------------------------|-----------------------| | Sample Concentration | % of Cutoff | Number of Determination | Immunoassay Result | Number of Determination | Immunoassay Result | | 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative | | 75 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative | | 150 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative | | 225 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative | | 300 ng/mL | 100.0% | 22 | 1 Pos/21 Neg | 88 | 23 Pos/65 Neg | | 375 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive | | 450 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive | | 525 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive | | 600 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive | ## Performance Characteristics Summary: 100 & 300 ng/mL Cutoff #### Hitachi 717 Analyzer #### Linearity: 100 & 300 ng/mL Cutoff Hitachi 717 Instrument: 0 - 800 ng/mL When comparing the result (y) and target (x) value, using the least squares regression i technique, the regression equation and correlation are as follows: y = 0.974x + 1.4518, r2 = 0.998 ## Method Comparison - Clinical Samples: 100 ng/mL Cutoff From a total of eighty-nine (89) clinical unaltered samples: Semi-Quantitative & Qualitative Data: 93.75% agreement with positive, 100.0% agreement with negative samples ## Method Comparison - Clinical Samples: 300 ng/mL Cutoff From a total of one-hundred and one (101) clinical unaltered samples: Semi-Quantitative & Qualitative Data: 96.1% agreement with positive, 98.0% agreement with negative samples ## Endogenous Compound Interference & Specificity & Cross-Reactivity: No significant undesired cross-reactants or endogenous substance interference was observed. ### Summary: The information provided in this pre-market notification demonstrates that the LZI Oxycodone Enzyme Immunoassay is substantially equivalent to the legally marketed Oxycodone Emerine 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 chromatography/mass spectrometry (GC/MS {6}------------------------------------------------ or LC/MS), an independent analytical method. The information supplied in this premarket notification provides reasonable assurance that the LZI Oxycodone Enzyme Immunoassay is safe and effective for its stated intended use. . · : 上 . . {7}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like bird figure with three curved lines representing its wings and body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". #### Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Lin-Zhi International, Inc c/o Bernice Lin, Ph.D. 670 Almanor Avenue Sunnyvale, CA 94085 JUN - 1 2012 k120763 Re: Trade Name: LZI Oxycodone Enzyme Immunoassay LZI Oxycodone Drugs of Abuse (DAU) Calibrators, LZI Oxycodone Drugs of Abuse (DAU) Controls Regulation Number: 21 CFR §862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Codes: DJG, DLJ, LAS Dated: April 27, 2012 Received: April 30, 2012 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 Eederal 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {8}------------------------------------------------ #### Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice for your as . Device Evaluation and Safety at (301) 796-5450. Also, comaci the Office of In Viro Diaghostics Dolive by reference to premarket notification" (2) please note the regulation entition, "Milion nownarket surveillance, please contact CDRH 's CI's Fat 607.97). I of questions regarding postmarket Surveillance at (01) Office of Surveinance and Dromotive of OSE of of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/Safety/ReportaProblem/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 Tou may other builer general memational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm Sincerely vours, Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ Lin-Zhi International, Inc. #### CONFIDENTIAL ### Premarket Notification ### Indications for Use Statement 510(k) Number (if known): #### Device Name: LZI Oxycodone Enzyme Immunoassay #### Indications for Use: The LZI Oxycodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of Oxycodone in human urine at the cutoff values of 100 and 300 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures. The LZI Oxycodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oxycodone Enzyme Immunoassay. The LZI Oxycodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Oxycodone Enzyme Immunoassay. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. Prescription Use V V AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D). (21 CFR 807 Subpart C) **Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)** (Per 21 CFR 801.109) Division Sign-Off Office of In Vitro Diagnostic Office of in wills brand Safety 510(k) K120763 Page of of 10