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For in vitro diagnostic use only. VITROS Chemistry Products AMPH Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi- quantitative or qualitative determination of amphetamines (AMPH) in human urine using a cutoff of either 500 or 1000 ng/mL. Measurements obtained with the VITROS AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The VITROS Chemistry Products AMPH 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 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 AMPH assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products AMPH 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 AMPH Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect amphetamines 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 d-amphetamine and d-methamphetamine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD*), followed by Reagent 2 containing damphetamine and d-methamphetamine, both labeled with the enzyme glucose-6phosphate dehydrogenase (G6P-DH). The assay is based on competition between amphetamines in the treated urine sample and the d-amphetamine and dmethamphetamine 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 amphetamines 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 Chemistry Products FS Calibrator 1 is prepared from sodium chloride and processed water. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative and semiquantitative measurement of amphetamines (AMPH).

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 VITROS AMPH 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.

1. A table of acceptance criteria and the reported device performance

The provided text does not contain explicit acceptance criteria in a quantitative format (e.g., minimum sensitivity, specificity, or agreement percentages). Instead, the claim is based on "substantial equivalence" to a predicate device. The performance comparison focuses on similarities in intended use, methodology, and general performance characteristics.

Therefore, the table below will reflect the comparison made in the document to establish substantial equivalence rather than pre-defined acceptance criteria.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as a comparison study between the new VITROS AMPH assay and the predicate device, Syva® EMIT II Plus Amphetamines assay. The summary states: "The performance of the VITROS AMPH assay on the VITROS 5,1 FS Chemistry System was compared to the Syva® EMIT II Plus Amphetamines assay on the SYVA 30R System. The results demonstrated good agreement between the two immunoassay methods." This comparison, along with detailed characteristics, aimed to establish "substantial equivalence" as the basis for market clearance.

2. Sample sized used for the test set and the data provenance

• Sample Size (Test Set): The document states "patient samples" were used for the comparison study, but it does not specify the exact number or sample size of these patient samples.
• Data Provenance: The document does not specify the country of origin for the patient samples. It also doesn't explicitly state whether the data was retrospective or prospective, though the nature of comparing a new device against a legally marketed predicate often includes prospective testing of new samples or retrospective analysis of samples previously tested by the predicate. Given "patient samples" were used, it implies clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information regarding the number of experts, their qualifications, or their role in establishing ground truth for the test set.

4. Adjudication method for the test set

The document does not specify any adjudication method used 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 vs without AI assistance

This is an in vitro diagnostic device (an assay for amphetamines in urine), not an imaging or diagnostic device that requires human "readers" or AI assistance in the way a MRMC study would typically evaluate. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance was not applicable and not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance evaluation described for the VITROS AMPH assay is a standalone (algorithm only) performance assessment. The assay is an automated chemical test run on a chemistry system, and its performance is evaluated in direct comparison with the predicate immunoassay. Human interpretation is involved in setting cutoffs and clinical judgment, but the performance of the assay itself is automatic.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the comparison appears to be primarily the results obtained from the predicate device (Syva® EMIT II Plus Amphetamines assay), which is also an immunoassay. The document also mentions that d-methamphetamines for calibration traceability are confirmed by GC/MS (Gas chromatography/mass spectrometry), which is generally considered a highly specific and confirmatory method for drug testing and would likely be the ultimate "ground truth" if independent confirmation was sought for the patient samples used in the comparison. However, the direct comparison used the predicate as the reference.

8. The sample size for the training set

This document describes a premarket notification for an in vitro diagnostic assay, not a machine learning or AI algorithm in the contemporary sense that would have an explicit "training set" for model development. The assay is based on chemical reactions and immunoassay principles. Therefore, there is no identifiable "training set" sample size for an AI model.

9. How the ground truth for the training set was established

As there is no "training set" in the context of an AI algorithm, the concept of establishing ground truth for it is not applicable to this device. The development of an immunoassay involves extensive biochemical and analytical validation, not machine learning training. The calibrators and controls used are prepared standards with known concentrations, traceable to GC/MS, serving as reference points.

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