(114 days)
For in vitro diagnostic use only. VITROS Chemistry Products OP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semiquantitative or qualitative determination of opiates (OP) in human urine using a cutoff of either 300 ng/mL or 2000 ng/mL. Measurements obtained with the VITROS OP method are used in the diagnosis and treatment of opiate use or overdose.
The VITROS Chemistry Products OP 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.
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 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 Chemistry Products OP assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products OP Reagent with the VITROS Chemistry Products Calibrator Kit 26 and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems. Two protocols using the VITROS OP assay are available to support the two cutoff values. The OP-LO protocol is used to support the 300 ng/mL cutoff value. The OP-HI protocol is used to support the 2000 ng/mL cutoff value.
The VITROS OP Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect opiates 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 morphine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD'), followed by Reagent 2 containing morphine labeled with the enzyme glucose-6phosphate dehydrogenase (G6P-DH). The assay is based on competition between opiates in the treated urine sample and the morphine 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 opiates 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.
The 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 Calibrator Kit 26 is a single fluid and from it six dilutions are performed on the VITROS 5,1 FS Chemistry System to create a total of six calibrators. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative and semi-quantitative measurement of Opiates (OP).
The VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V are quality control materials 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 OP 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 by multiple assays on the VITROS 5,1 FS Chemistry 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 VITROS 5,1 FS System was cleared for marker by 510(k) premarket notification (K031924).
The document describes the VITROS Chemistry Products OP Reagent, Calibrator Kit 26, and DAT Performance Verifiers, which are used for the semi-quantitative or qualitative determination of opiates in human urine. The study presented in the Section 510(k) premarket notification demonstrated substantial equivalence to predicate devices, providing reasonable assurance of safety and effectiveness.
Here’s a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with specific performance metrics beyond general "good agreement" with the predicate device. The primary claim is substantial equivalence to the predicate devices (EMIT® II Plus Opiate assay and Bio-Rad Liquicheck™ Urine Toxicology Controls) for in vitro diagnostic use.
| Acceptance Criteria | Reported Device Performance (VITROS Chemistry Products OP Reagent) |
|---|---|
| Intended Use Equivalence: For in vitro diagnostic use, qualitative/semi-quantitative analysis of opiates in human urine at 300 ng/mL or 2000 ng/mL cutoff. Controls monitor performance. | Meets: Same intended use as predicate devices. Used for semi-quantitative or qualitative determination of opiates (OP) in human urine using a cutoff of either 300 ng/mL or 2000 ng/mL. DAT Performance Verifiers monitor performance of urine drugs of abuse screening assays. |
| Test Principle Equivalence: Homogeneous enzyme immunoassay. | Meets: Homogeneous enzyme immunoassay. |
| Cut-Off Values: 300 ng/mL or 2000 ng/mL. | Meets: Available to support both 300 ng/mL and 2000 ng/mL cutoff values. |
| Specimen Type: Human Urine. | Meets: Detects opiates in human urine. |
| Reagent Format: Liquid, ready to use. | Meets: Liquid, ready-to-use reagents. |
| Antibody Source: Sheep polyclonal antibodies reactive to morphine. | Meets: Sheep polyclonal antibodies reactive to morphine. |
| Calibration Traceability: Traceable to morphine with GC/MS confirmation. | Meets: Traceable to morphine with confirmation by GC/MS. |
| Calibrator Matrix: Human Urine. | Meets: Prepared from human urine. |
| Control Matrix: Human Urine. | Meets: Prepared from a human urine pool. |
| Overall Performance: Good agreement with predicate immunoassay method. | Met: "The results demonstrated good agreement between the two immunoassay methods." (VITROS OP assay vs. EMIT® II Plus Opiate assay). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "patient samples" were used to demonstrate equivalence but does not specify the exact number or size of the test set.
- Data Provenance: Not explicitly stated, but clinical studies are generally expected to involve diverse patient populations, often implying data from the country of manufacture or where clinical trials are conducted (e.g., USA, given the FDA submission). The study is retrospective in the sense that it compares to an existing, legally marketed predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set.
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 versus without AI assistance
This is an in vitro diagnostic device for laboratory analysis, not an imaging or AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the primary evaluation presented is a standalone performance of the VITROS Chemistry Products OP assay system, compared to another standalone laboratory assay (EMIT® II Plus Opiate assay). The device itself is an automated chemistry system.
7. The Type of Ground Truth Used
The ground truth for the test set appears to be established by comparison to a "commercially available assay" (EMIT® II Plus Opiate assay) that is already cleared. Additionally, for calibration traceability, it is stated that it is "Traceable to morphine with confirmation by GC/MS." Gas chromatography/mass spectrometry (GC/MS) is considered the preferred confirmatory method for drug-of-abuse test results and would represent the highest level of ground truth in this context.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" as this is not a machine learning or AI-based device in the sense that it requires a separate training phase. The device is a chemical reagent and instrument system, calibrated using a specified calibrator kit.
9. How the Ground Truth for the Training Set was Established
As there's no "training set" in the context of an AI/ML model, this question is not applicable. The device is calibrated using the VITROS Chemistry Products Calibrator Kit 26, which is prepared from human urine with drugs of abuse, metabolites, and other substances added. This calibration is stated to be "Traceable to morphine with confirmation by GC/MS."
§ 862.3650 Opiate test system.
(a)
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.(b)
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).