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The CEDIA® DAU Multi-Drug Calibrators are intended for the calibration of qualitative and semiquantitative CEDIA® DAU Assays on automated clinical chemistry andy zers.

The CEDIA ® DAU Multi-Drug Calibrators are manufactured using drug free human urine, various drugs of abuse and a preservative. At this time, the drugs of abuse are d-methamphetamine, secobarbital, nitrazepam, morphine, benzoylecgonine, phencyclidine, and EDDP. The drug raw materials are obtained from a commercially available source and are spiked appropriately into the calibrator matrix to obtain the correct calibrator concentration levels. The calibrators are in-process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have had values confirmed using GC/MS by 3 laboratories.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CEDIA® DAU Multi-Drug Calibrators:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, specifically regarding EDDP (Methadone Metabolite) concentration. It does not contain a comprehensive "acceptance criteria" table as would typically be presented for a new or significantly modified device, nor does it detail a study that proves the device meets broad performance acceptance criteria beyond the specific EDDP concentration verification.

However, based on the information provided, we can extract the relevant performance data and study details for the EDDP component.

1. Table of Acceptance Criteria and Reported Device Performance

For the specific aspect of EDDP concentration within the CEDIA® DAU Multi-Drug Calibrators:

Note: The document implies that meeting these target concentrations demonstrates satisfactory performance for the EDDP component, thus serving as an implicit acceptance criterion for this specific performance characteristic in the context of substantial equivalence.

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

• Sample Size: Not explicitly stated how many individual calibrator samples were tested for each concentration level (Primary Cutoffs, Secondary Cutoffs, Intermediate, High). The results are presented as "Mean [EDDP] ng/mL," suggesting multiple replicates were tested to arrive at these means.
• Data Provenance: The calibrators were manufactured by Boehringer Mannheim Corporation (USA-based company). The testing was for an in-house product. The document does not specify the country of origin of the raw human urine used in the calibrators. The study is retrospective in the sense that it's a verification of a manufactured product designed to meet established concentration levels.

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

• Number of Experts/Laboratories: The "ground truth" for the calibrators with the addition of EDDP was established by 2 separate laboratories using GC/MS (Gas Chromatography/Mass Spectrometry).
• Qualifications of Experts: Not explicitly stated, but GC/MS is a highly precise analytical technique, implying the laboratories and their personnel would be qualified analytical chemists/scientists experienced in such methods.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The text states "The CEDIA® DAU Multi-Drug Calibrators were analyzed for EDDP by GC/MS in 2 separate laboratories. The results of the study were as follows:". This suggests that the results from the two laboratories were combined or compared, but the specific method of reconciliation if there were discrepancies (e.g., averaging, independent verification by a third party, or requiring agreement within a certain tolerance) is not detailed. The reported "Mean [EDDP] ng/mL" for each calibrator implies an averaging or consensus of results between the two labs.

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

• No, an MRMC comparative effectiveness study was not reported. This type of study is typically for diagnostic imaging devices where human readers interpret results with and without AI assistance. The CEDIA® DAU Multi-Drug Calibrators are in-vitro diagnostic products (calibrators for assays), and their performance evaluation methods differ.

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

• This question is not applicable in the traditional sense of an "algorithm" or "AI" device. The device is a set of chemical calibrators. The "standalone" performance here refers to the analytical accuracy of the calibrator itself, which was tested by GC/MS. The results in the table ("Mean [EDDP] ng/mL") represent this standalone performance, where the calibrators' concentrations were measured independently.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the EDDP concentrations was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is considered a definitive analytical method, often referred to as a "gold standard" for quantifying specific compounds in complex matrices. This method provides objective, quantitative measurement data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document describes the CEDIA® DAU Multi-Drug Calibrators as being "in-process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have had values confirmed using GC/MS by 3 laboratories."
  • This refers to the preparation and quality control of the calibrators themselves, rather than a "training set" for an algorithm. The reference calibrators could be considered analogous to a "training/development set" in that they are used to establish and verify the manufacturing process. However, a specific sample size for this "training" aspect is not provided.
  • For the drug raw materials, it mentions they are "obtained from a commercially available source and are spiked appropriately into the calibrator matrix to obtain the correct calibrator concentration levels." This process itself relies on prior knowledge and standards.

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

• Ground Truth for Training Set (Reference Calibrators): The ground truth for the "in-house reference calibrators" (which can be seen as the basis for developing and controlling the manufacturing process) was established using GC/MS by 3 laboratories. This indicates a high level of analytical rigor for these internal reference standards.

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