(31 days)
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.
Immunalysis cTHC Urine Control Set: The Immunalysis cTHC Urine Control Set is used as control materials in the Immunalysis Cannabinoids Urine Enzyme Immunoassay.
Immunalysis cTHC Urine Calibrators: The Immunalysis cTHC Urine Calibrators are used as calibrators in the Immunalysis Cannabinoids Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Cannabinoids in urine on automated clinical chemistry analyzers.
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal and polyclonal antibodies to Cannabinoids, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Cannabinoids derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use.
All of the Immunalysis cTHC Urine Calibrators and Controls are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.
The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control and HIGH Control are prepared by spiking known concentrations of 11-nor-9-carboxy-Δ'-THC (cTHC) into the negative calibrator matrix. The negative calibrator, Level 1 calibrator, Level 2 calibrator, Level 3 calibrator, Level 4 calibrator and two controls are sold as individual bottles.
The document describes the Immunalysis Cannabinoids Urine Enzyme Immunoassay, its calibrators, and control set, which are intended for qualitative and semi-quantitative analysis of Cannabinoids in human urine with a cutoff of 50ng/mL. The study evaluates the performance of the device against this cutoff.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document for each test. However, the studies demonstrate the device's performance relative to its intended use and consistency around the 50 ng/mL cutoff. The implicit acceptance criteria appear to be:
- Qualitative Analysis: Accurate classification of samples as negative below the -25% cutoff and positive above the +25% cutoff, with consistent results at the cutoff.
- Semi-Qualitative Analysis: Similar to qualitative, with consistent results around the cutoff.
- Specificity and Cross-Reactivity: Structurally similar compounds should show expected cross-reactivity, and structurally dissimilar compounds should not interfere.
- Interference: Various endogenous compounds, pH levels, and specific gravity should not cause interference.
- Recovery: Expected concentrations should be recovered within an acceptable range.
- Method Comparison: High agreement with LC/MS confirmation for both qualitative and semi-quantitative modes.
- Calibration and Control Performance: Traceability and stability of calibrators and controls within specifications.
| Test Category | Acceptance Criteria (Implicit from study design) | Reported Device Performance |
|---|---|---|
| Qualitative Analysis (50ng/mL cutoff) | Samples at -100%, -75%, -50%, -25% of cutoff should be Negative. Samples at +25%, +50%, +75%, +100% of cutoff should be Positive. At cutoff (50ng/mL), mixed results are expected. | Table 2: |
- Samples at 0, 12.5, 25, 37.5 ng/ml (cutoffs -100% to -25%) showed 80 Negative results (100% agreement).
- Samples at 50 ng/ml (cutoff) showed 40 Negative/40 Positive results.
- Samples at 62.5, 75, 87.5, 100 ng/ml (cutoffs +25% to +100%) showed 80 Positive results (100% agreement). |
| Semi-Quantitative Analysis (50ng/mL cutoff)| Similar to qualitative analysis. | Table 3: - Samples at 0, 12.5, 25, 37.5 ng/ml showed 80 Negative results (100% agreement).
- Samples at 50 ng/ml (cutoff) showed 38 Negative/42 Positive results.
- Samples at 62.5, 75, 87.5, 100 ng/ml showed 80 Positive results (100% agreement). |
| Specificity & Cross-Reactivity (Structurally Related Compounds - Qualitative)| Expected varying cross-reactivity for structurally similar compounds at specific concentrations. | Table 4: - 11-nor-9-carboxy-Δ9-THC (50ng/mL): 100% Cross-Reactivity (Positive)
- (±) 11-Hydroxy-Δ9-THC (100ng/mL): 50.0% Cross-Reactivity (Positive)
- 11-nor-Δ8-carboxy-THC (40ng/mL): 125.0% Cross-Reactivity (Positive)
- Cannabinol (75ng/mL): 66.7% Cross-Reactivity (Positive)
- Cannabidiol (1,000,000ng/mL):
§ 862.3870 Cannabinoid test system.
(a)
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 includedelta -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.(b)
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).