Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set

K151203 · Immunalysis Corporation · LDJ · Jun 5, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151203
• Device Name: Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
• Applicant: Immunalysis Corporation
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Indications for Use

The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers. This assay is calibrated against 11-nor-9-carboxy-A9-THC (cTHC). This in-vitro device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Cannabinoids Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/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

The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay used in clinical laboratories to detect cannabinoids in human urine. The device utilizes an antibody/substrate reagent containing monoclonal and polyclonal antibodies to cannabinoids, G6P, and NAD, and an enzyme conjugate reagent containing a cannabinoid derivative labeled with G6PDH. When cannabinoids are present in the urine sample, they compete with the enzyme-labeled drug for antibody binding sites, modulating enzyme activity. The assay is performed on automated clinical chemistry analyzers. Results are qualitative or semi-quantitative, providing a preliminary screen that requires confirmation via GC-MS or LC/MS. The device includes liquid, ready-to-use calibrators and controls spiked with 11-nor-9-carboxy-Δ9-THC. The output assists healthcare providers in identifying potential drug use, necessitating clinical judgment and confirmatory testing for definitive diagnosis.

Clinical Evidence

Bench testing only. Precision study (N=80) performed over 20 days verified cutoff performance. Specificity and cross-reactivity evaluated against structurally related and non-similar compounds. Interference testing confirmed assay performance is unaffected by endogenous compounds, pH, or specific gravity. Method comparison study against LC/MS (N=80) showed 100% agreement for both qualitative and semi-quantitative modes at the 50ng/mL cutoff.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: antibody/substrate (monoclonal/polyclonal antibodies, G6P, NAD) and enzyme conjugate (G6PDH-labeled cannabinoid derivative) in Tris buffer with sodium azide. Liquid, ready-to-use form. Designed for automated clinical chemistry analyzers. Storage at 2-8°C.

Indications for Use

Indicated for the qualitative and semi-quantitative analysis of Cannabinoids in human urine for laboratory use on automated clinical chemistry analyzers. Intended for prescription use only. Provides preliminary analytical test results requiring confirmation by GC-MS or LC/MS.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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) #: k151203

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.