LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)

K141055 · Lin-Zhi International, Inc. · DJG · Jun 13, 2014 · Clinical Toxicology

Device Facts

• Record ID: K141055
• Device Name: LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)
• Applicant: Lin-Zhi International, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jun 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The LZI Hydrocodone Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of hydrocodone in human urine at the cutoff values of 100 and 300 ng/mL. The assay is designed for prescription 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 Hydrocodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Hydrocodone Enzyme Immunoassay at the cutoff values of 100 and 300 ng/mL. The LZI Hydrocodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Hydrocodone Enzyme Immunoassay at the cutoff values 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 hydrocodone detection in human urine; utilizes competitive binding between sample drug 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., AU480) by trained technicians. Provides rapid screening; positive results require confirmation via GC/MS or LC/MS. Assists clinicians in identifying potential hydrocodone use; supports laboratory specimen dilution and quality control workflows.

Clinical Evidence

Bench testing only. Evaluated 80 clinical urine specimens per cutoff (100 and 300 ng/mL) against GC/MS or LC/MS reference methods. 100 ng/mL cutoff showed 92.5% agreement; 300 ng/mL cutoff showed 95.0% agreement. Precision, linearity, and interference studies (endogenous compounds, pH, specific gravity) demonstrated acceptable performance.

Technological Characteristics

Homogeneous enzyme immunoassay; liquid reagents (R1: mouse monoclonal anti-hydrocodone antibody, G6P, NAD; R2: G6PDH-labeled hydrocodone). Spectrophotometric detection at 340 nm. Designed for automated clinical chemistry analyzers. Storage 2-8°C.

Indications for Use

Indicated for qualitative and semi-quantitative determination of hydrocodone in human urine at 100 or 300 ng/mL cutoffs. For prescription use in clinical laboratories to screen for hydrocodone presence. Preliminary result only; requires confirmation by GC/MS or LC/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).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k141055

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.