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For in vitro diagnostic use only. VITROS Chemistry Products BARB Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose.

The VITROS Chemistry Products BARB 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 BARB assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products BARB 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 BARB Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect barbiturates 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 secobarbital, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD*), followed by Reagent 2 containing secobarbital labeled with the enzyme glucose-6phosphate dehydrogenase (G6P-DH). The assay is based on competition between barbiturates in the treated urine sample and secobarbital labeled with the enzyme glucose-6phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of barbiturates 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 barbiturates (BARB).

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 BARB 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 market by 510(k) premarket notification (K031924).

The provided text describes a 510(k) premarket notification for the VITROS Chemistry Products BARB Reagent and associated calibrators and verifiers. This is a submission for an in-vitro diagnostic device, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting a new clinical efficacy study with acceptance criteria often seen in device approvals.

Therefore, the information traditionally requested for acceptance criteria and a study proving a device meets these criteria (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available in this type of submission.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. The "study" described is a comparison study against a predicate device.

Here's a breakdown of what can be extracted or inferred from the provided text, framed within your request:

1. Table of Acceptance Criteria and Reported Device Performance

Formal, pre-defined acceptance criteria (e.g., target specificity/sensitivity thresholds) for performance against a gold standard are not explicitly stated as they would be for a novel device efficacy claim. Instead, the "acceptance" hinges on demonstrating "good agreement" and "similar performance characteristics" to the predicate device.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "patient samples" were used to demonstrate equivalence. The exact number of patient samples used in the comparison study is not provided.
• Data Provenance: Not specified, but likely from a clinical laboratory or labs in the US, given the submission to the FDA. The term "patient samples" suggests a retrospective or prospective collection, but this detail is also not specified.

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

• Ground Truth Establishment: For in vitro diagnostic assays for drugs of abuse, the "ground truth" is typically established by a highly sensitive and specific reference method, not by expert consensus (e.g., pathologists or radiologists). The document explicitly 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."
• Expert Qualifications: Not applicable in the context of establishing ground truth for this type of assay.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is common. For an in vitro diagnostic assay with a quantitative gold standard (GC/MS), this process would not be used.

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

• Not applicable. This is not an imaging or AI-assisted diagnostic device that involves human readers interpreting results. It is an automated laboratory assay.

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

• The VITROS BARB assay is an automated homogeneous enzyme immunoassay performed on the VITROS 5,1 FS Chemistry System. Therefore, its performance is inherently standalone (algorithm/instrument only) as it provides a result without direct human interpretation of the reaction signals, though human laboratory personnel operate the system and interpret the final reported numerical or qualitative result. This study implicitly demonstrates standalone performance relative to the predicate device.

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

• The implicit "ground truth" for confirmation is Gas Chromatography/Mass Spectrometry (GC/MS), which is stated as the preferred confirmatory method for positive results. The calibration traceability is also tied to secobarbital confirmed by GC/MS. This is a highly accurate analytical chemistry method.

8. The sample size for the training set

• Not applicable. For this type of immunoassay, there isn't a "training set" in the machine learning sense. The assay is developed based on chemical and biological principles (antibody-antigen reactions, enzyme kinetics) rather than being trained on a dataset. Reference standards and controls are used for calibration and quality control, but this is distinct from a machine learning training set.

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

• Not applicable, as there is no "training set" in the machine learning context. The calibrators and controls used are prepared standards with known concentrations, traceable to secobarbital with GC/MS confirmation (as mentioned for calibration traceability).

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