(71 days)
VITROS Chemistry Products THC Reagent: For in vitro diagnostic use only. VITROS Chemistry Products THC Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of cannabinoids (THC) in human urine using a cutoff of either 20 ng/mL or 50 ng/mL. Measurements obtained with the VITROS THC method are used in the diagnosis and treatment of cannabinoid use or overdose.
The VITROS Chemistry Products THC assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result.
VITROS Chemistry Products Calibrator Kit 30: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 30 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of cannabinoids (THC).
VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V: For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
The VITROS THC assay is a homogeneous enzyme immunoassay that is performed using the VITROS THC Reagent with the VITROS Calibrator Kit 30, VITROS FS Calibrator 1 and VITROS FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems.
The VITROS THC Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect cannabinoids in urine. Sample, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibodies reactive to delta-9-tetrahydrocannabinol (delta-9-THC), glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD+), followed by Reagent 2 containing delta-9-THC labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH), The assay is based on competition between delta 9-THC metabolites in the treated urine sample and the delta 9 -THC labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of delta-9-THC metabolites in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD+) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.
VITROS Calibrator Kit 30 is prepared from human urine to which analyte, surfactant, and preservatives have been added. The VITROS FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline). These calibrators are used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semiquantitative measurement of cannabinoids (THC).
VITROS DAT Performance Verifiers I, II, III, IV and V are prepared from a human urine pool to which analytes, surfactant, and preservative have been added. These are assayed controls used to monitor performance of the VITROS THC assay on VITROS 5,1 FS Chemistry Systems.
The VITROS FS Diluent Pack 4 (DAT Diluent/ DAT Diluent 2) is a common reagent that is used with several drugs of abuse assays to dilute calibrators and samples on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. DAT Diluent is prepared from human urine to which organic salt, surfactants, and preservative have been added. DAT Diluent 2 is prepared from processed water to which surfactant and preservative have been added.
The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) Premarket Notification (K031924).
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the VITROS THC assay, which is a homogeneous enzyme immunoassay for the semi-quantitative or qualitative determination of cannabinoids (THC) in human urine. The acceptance criteria are implicitly defined by the device's substantial equivalence to predicate devices, meaning its performance should be comparable to or better than previously cleared devices.
| Performance Characteristic | Acceptance Criteria (Implicit - based on predicate equivalence) | Reported Device Performance (VITROS THC assay) |
|---|---|---|
| Accuracy/Agreement | Good agreement with predicate immunoassay methods. | "The results demonstrated good agreement between each of the immunoassay methods [VITROS THC assay vs. SYVA® EMIT® II Plus Cannabinoid assay on OLYMPUS® AU400™ and SYVA® 30R Biochemical System]." |
| Precision | Not explicitly stated, but expected to be acceptable. | Bench testing was performed to determine "assay precision." (Specific values not provided in this summary) |
| Linearity | Not explicitly stated, but expected to be acceptable. | Bench testing was performed to determine "linearity." (Specific values not provided in this summary) |
| Specificity | Not explicitly stated, but expected to be acceptable. | Bench testing was performed to determine "specificity." (Specific values not provided in this summary) |
| Limit of Detection | Not explicitly stated, but expected to be acceptable. | Bench testing was performed to determine "limit of detection." (Specific values not provided in this summary) |
| Stability | Not explicitly stated, but expected to be acceptable. | Bench testing was performed to determine "stability" of the VITROS THC assay. (Specific values not provided in this summary) |
| Intended Use | Same as predicate devices (in vitro diagnostic for cannabinoids in human urine). | "The assays are intended for use in the qualitative and semi-quantitative analysis of cannabinoids in human urine." (Matches predicate) |
| Test Principle | Homogeneous enzyme immunoassay. | "Homogeneous enzyme immunoassay." (Matches predicate) |
| Sample Type | Human Urine. | "Human Urine." (Matches predicate) |
| Reagent Format | Liquid ready to use. | "Liquid ready to use." (Matches predicate) |
| Antibody Source | Mouse monoclonal antibodies reactive to delta 9-tetrahydrocannabinol. | "Mouse monoclonal antibodies reactive to delta 9-tetrahydrocannabinol." (Matches predicate) |
| Calibrator Analyte | 11-nor-delta-9-THC-9-COOH. | "11-nor-delta-9-THC-9-COOH." (Matches predicate) |
| Calibrator/Control Format | Refrigerated: Liquid, ready to use. | "Refrigerated: Liquid, ready to use." (Matches predicate) |
| Calibrator Matrix | Human urine. | "Human urine." (Matches predicate) |
| Control Matrix | Human urine. | "Human urine." (Matches predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that "patient samples" were used for correlation studies. However, the exact number or size of the test set is not explicitly provided in the summary.
- Data Provenance: Not explicitly stated, but the context of an FDA 510(k) submission for a diagnostic product generally implies regulated, clinical laboratory-generated data. The mention of "patient samples" suggests a clinical setting. The country of origin is not specified but is implicitly in the US due to the FDA submission. The study is retrospective in the sense that it uses existing data or samples to compare the new device to already marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable or not specified. In this type of diagnostic device submission, the "ground truth" for the test set is established by the results from the predicate devices (SYVA® EMIT® II Plus Cannabinoid Assay on OLYMPUS® AU400™ and SYVA® 30R Biochemical System) or by a "more specific alternative chemical method" like GC/MS for confirmation.
- Qualifications of Experts: Not applicable, as expert consensus is not the method for establishing ground truth described here. The predicate devices themselves are considered the established standard.
4. Adjudication Method for the Test Set:
- Not applicable as expert adjudication is not described. The study compared the VITROS THC assay results directly to the results obtained from the predicate devices. For positive results, confirmation by Gas Chromatography/Mass Spectrometry (GC/MS) is stated as the preferred method, implying a definitive or "gold standard" for confirmation, rather than human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) chemistry product, not an imaging or AI-assisted diagnostic tool that involves human readers interpreting output. Its performance is assessed directly against chemical measurements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This device is inherently a standalone algorithm/device in its function. It performs an automated chemical analysis on a sample and provides a result (qualitative or semi-quantitative for THC). Human involvement is limited to sample loading, system operation, and interpretation of the numerical result as per clinical guidelines, not in generating the primary diagnostic output itself.
7. The Type of Ground Truth Used:
- The ground truth for the test set was established by comparison to predicate immunoassay methods (SYVA® EMIT® II Plus Cannabinoid Assay) and implied confirmatory methods such as Gas Chromatography/Mass Spectrometry (GC/MS) for preliminary positive results, as stated in the intended use. This represents a form of established diagnostic standard/reference method.
8. The Sample Size for the Training Set:
- The document does not provide information regarding a specific "training set" or its sample size. This is typical for such diagnostic assays, which are developed through iterative optimization and validation processes rather than machine learning training on a distinct "training set" in the common sense. The extensive bench testing for precision, linearity, specificity, and LOD would involve numerous samples, but these are part of the overall development and validation, not a separate "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established:
- As a distinct "training set" is not described in the context of this traditional IVD product, the method for establishing its ground truth is not applicable. The underlying chemical principles and established reference methods (like GC/MS) guide the development and optimization of such assays.
§ 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).