LZI Fentanyl II Enzyme Immunoassay

K201938 · Lin-Zhi International, Inc. · DJG · Aug 7, 2020 · Clinical Toxicology

Device Facts

• Record ID: K201938
• Device Name: LZI Fentanyl II Enzyme Immunoassay
• Applicant: Lin-Zhi International, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Aug 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The LZI Fentanyl II Enzyme Immunoassay is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. 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 qualitative norfentanyl detection in human urine. Uses competitive binding between sample drug and fentanyl-labeled G6PDH enzyme for fixed antibody sites. Enzyme activity is inhibited when antibody binds to drug-labeled conjugate; free drug in sample displaces conjugate, increasing enzyme activity. Active enzyme converts NAD to NADH, measured spectrophotometrically at 340 nm. Used in clinical labs on automated chemistry analyzers (e.g., Beckman Coulter AU480) by professional staff. Provides preliminary screening results; requires confirmatory testing via chromatography/mass spectrometry. Assists clinicians in identifying potential fentanyl exposure; supports clinical decision-making regarding drug use.

Clinical Evidence

Bench testing only. Evaluated 100 clinical urine samples against LC/MS confirmation. Precision studies (N=88) performed on Beckman Coulter AU480. Cross-reactivity and interference testing (endogenous, pH, specific gravity) conducted. Dextromethorphan (40,000 ng/mL) and Boric Acid (1% w/v) showed interference. No clinical prospective/retrospective trials on patients reported.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: R1 (mouse monoclonal anti-fentanyl antibody, G6P, NAD, stabilizers, 0.09% sodium azide); R2 (fentanyl-labeled G6PDH, buffer, 0.09% sodium azide). Detection: Spectrophotometric absorbance at 340 nm. Storage: 2-8°C. Compatible with automated clinical chemistry analyzers.

Indications for Use

Indicated for qualitative detection of norfentanyl in human urine at 5 ng/mL cutoff. For prescription use in clinical settings to aid in drug of abuse screening. Requires confirmatory testing via 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)

{0}

1

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

510(k) Number: K201938

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.