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The UDAT CAL is an in vitro diagnostic product for the calibration of Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTQ), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC) methods on the Dimension Vista™ System.

Device Description

UDAT CAL is a liquid, multi-analyte, drug free human urine based product containing: D-methamphetamine, Secobarbital, Lormetazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, 11-nor- $\Delta$ 9-THC-9-COOH, Propoxyphene, and Methylqualone. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL for Calibrator A and 2.6 mL for Calibrator B. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

AI/ML Overview

The provided text describes a 510(k) submission for the Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510). This is a calibrator material, not an AI/ML-driven device, so many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable or directly addressed in the context of typical AI/ML device evaluations.

However, based on the performance characteristics provided for this calibrator material, here's an attempt to structure the information as requested, highlighting where the AI/ML specific criteria do not apply.

Acceptance Criteria and Device Performance for Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Stability (Shelf Life)	Target shelf life for the calibrator is nine months. Percent change over time should be less than or equal to 10% when comparing results of product stored at 4°C with control stored at -20°C.	Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc. (Implies satisfactory performance against the 10% change criterion for 9 months).
Punctured Vial Stability (On-instrument)	A vial punctured by the instrument and stored on board is stable for 24 hours.	Stated as "stable for 24 hours." (Implies satisfactory performance).
Opened Vial Stability (Recapped, Refrigerated)	An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days.	Stated as "stable for 31 days." (Implies satisfactory performance).
Traceability	Assigned values of the UDAT CAL are traceable to specified reference materials (USP for most analytes, Cerilliant for others).	The document explicitly lists the specific USP standards or Cerilliant sources for each analyte's constituent. (Implies successful traceability).
Bottle Value Assignment (Verification)	Master Lot values are verified against previously approved Master Lot values and GC/MS testing. The approved Master Lot values are assigned with an instrument calibrated with the corresponding standard reference material. Commercial lot concentrations are verified using an instrument calibrated with Master Lot and GC/MS testing. Values are approved if acceptable ranges are met.	The description details the multi-step verification process, including GC/MS testing and calibration against Master Lot values to ensure concentrations are within acceptable ranges. (Implies this process is followed and criteria met).

2. Sample Size Used for the Test Set and Data Provenance

This is not an AI/ML device testing data set in the traditional sense. The "testing" refers to internal validation studies of the calibrator's performance characteristics like stability and value assignment.

Sample Size for Test Set: Not explicitly stated as a single "test set" sample size. Stability testing involved multiple vials over time (e.g., punctured vials tested on Day 0, 1, 2, and 8; manually opened vials on Day 32). Bottle value assignment involved testing stock solutions and commercial lots.
Data Provenance: The data is internally generated by Dade Behring, Inc. as part of their product development and validation. This would be considered prospective in the context of their internal studies for product validation. The country of origin is implicitly the USA, where Dade Behring Inc. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as this is not an AI/ML device requiring expert interpretation of output. The "ground truth" for calibrators is established through analytical and metrological methods, primarily using highly pure reference materials (like USP standards and Cerilliant pure substances) and quantitative analytical techniques such as GC/MS. The "experts" involved would be analytical chemists or equivalent personnel qualified in laboratory methods and metrology. Their number and specific qualifications (e.g., years of experience) are not detailed as they are for clinical expert reviews.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for a calibrator's performance; it's based on objective analytical measurements against defined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, this is not an AI/ML device or an imaging device, therefore an MRMC study is not relevant or performed for a calibrator.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical calibrator material, not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth for the analyte concentrations in the calibrator material is established through:

Reference Materials: Highly characterized chemical reference materials (e.g., USP standards, Cerilliant 99% purity analytes).
Gravimetric Preparation: Exact weighing of these reference materials into drug-free human urine to create stock solutions and master lots.
Analytical Verification: Confirmation of concentrations using established analytical methods like Gas Chromatography/Mass Spectrometry (GC/MS), which provides highly accurate and specific quantification.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set." The product is manufactured and its performance characteristics (stability, accuracy of value assignment) are validated.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set. The "ground truth" for the calibrator's values is established from the reference materials, gravimetric preparation, and analytical verification methods described in point 7.

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