(137 days)
VITROS Chemistry Products BENZ Reagent is used on VITROS 5.1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
The VITROS Chemistry Products BENZ 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 drugof-abuse test result, particularly when evaluating a preliminary positive result.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
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.
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 BENZ assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products BENZ Reagent with the VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems.
The VITROS BENZ Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect benzodiazepines 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 antibody reactive to diazepam, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD), followed by Reagent 2 containing diazepam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between benzodiazepines in the treated urine sample and diazepam 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 benzodiazepines 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 Chemistry Products Calibrator Kit 26 is prepared from human urine to which drugs of abuse, metabolites of drugs of abuse, organic salt, surfactants, and preservative have been added. VITROS FS Calibrator 1 is prepared from sodium chloride and processed water. VITROS Calibrator Kit 26 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of benzodiazepine (BENZ).
VITROS Chemistry Products 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 BENZ assay on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products 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 Chemistry Products MicroTip® and MicroSlides® range of products.
The provided text describes a 510(k) premarket notification for the VITROS Chemistry Products BENZ assay and associated calibrators and verifiers. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI device might.
Therefore, much of the requested information (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, and specific acceptance criteria with reported performance values) is not detailed in this type of regulatory submission. The document emphasizes comparison to a predicate device for equivalence rather than setting and meeting novel performance benchmarks.
However, I can extract information related to the device, its intended use, and the comparison to the predicate.
Here's an attempt to answer based only on the provided text, with many fields necessarily left blank or noted as "Not applicable" due to the nature of the document:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, accuracy, or other performance metrics. Instead, it claims "good agreement" with the predicate device.
| Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device | "demonstrated good agreement between the two immunoassay methods." |
| Similar performance characteristics to predicate device | (Implied by the "good agreement" statement) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document generically mentions "patient samples" were used for comparison.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth for drug screening assays typically refers to confirmatory methods rather than expert interpretation of images or clinical data.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. The "ground truth" for drug screening is established through highly specific alternative chemical methods like GC/MS, not expert adjudication in the traditional sense.
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
- MRMC Study: No, this is not an AI device or an imaging device requiring human reader interpretation in the context of an MRMC study. This is an in vitro diagnostic assay.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The device is a standalone automated chemical assay (an in vitro diagnostic). Its performance is evaluated by comparing its results to a predicate device and, implicitly, to confirmatory methods. There is no "human-in-the-loop" component in the sense of a diagnostic interpretation aid, though lab personnel operate the system. The reported performance refers to the assay's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The document states: "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." Therefore, GC/MS serves as the reference standard (ground truth) for confirming benzodiazepine presence.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that undergoes "training" in the computational sense. It is an enzymatic immunoassay.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an immunoassay. The calibrators are prepared from human urine with known added drugs/metabolites, and controls are prepared similarly, but these are for calibration and monitoring, not for training a learning algorithm.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).