LZI Tramadol Enzyme Immunoassay
Device Facts
| Record ID | K201223 |
|---|---|
| Device Name | LZI Tramadol Enzyme Immunoassay |
| Applicant | Lin-Zhi International, Inc. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Jun 4, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The LZI Tramadol Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of tramadol in human urine at the cutoff value of 100 ng/mL when calibrated against tramadol. 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 gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures. 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
LZI Tramadol Enzyme Immunoassay is a homogeneous enzyme immunoassay for detecting tramadol in human urine. Input: human urine sample. Principle: competitive binding between drug in sample and drug-labeled G6PDH enzyme for fixed antibody; enzyme activity inhibited when bound to antibody; free drug in sample displaces labeled drug, increasing enzyme activity. Output: absorbance change measured spectrophotometrically at 340 nm, proportional to drug concentration. Used in clinical laboratories on automated chemistry analyzers by laboratory technicians. Results are preliminary; used to guide specimen dilution for confirmatory testing (GC/MS or LC/MS) or quality control. Benefits patient by providing rapid screening for tramadol presence, facilitating clinical decision-making regarding drug use.
Clinical Evidence
Bench testing only. Precision evaluated using modified NCCLS-EP5 protocol (N=88). Analytical recovery ranged 89-116%. Method comparison with 86 clinical samples against LC/MS showed 97.7% agreement for qualitative results. Cross-reactivity and interference studies (endogenous compounds, pH, specific gravity) performed on Beckman Coulter AU480 analyzer.
Technological Characteristics
Homogeneous enzyme immunoassay. Reagents: R1 (mouse monoclonal anti-tramadol antibody, G6P, NAD, stabilizers, 0.09% sodium azide) and R2 (tramadol-labeled G6PDH, buffer, 0.09% sodium azide). Sensing principle: spectrophotometric absorbance at 340 nm. Form factor: liquid reagents for automated clinical chemistry analyzers. Storage: 2-8°C.
Indications for Use
Indicated for qualitative and semi-quantitative determination of tramadol in human urine at a 100 ng/mL cutoff. For prescription use in clinical laboratories using automated chemistry analyzers. Provides preliminary results requiring 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).
