(61 days)
The ADVIA Chemistry TDM DRUG Calibrator II is for in vitro diagnostic use in the calibration of Carbamazepine 2 (CARB_2), Gentamicin_2 (GENT_2), Tobramycin_2 (TOBR 2), Valproic Acid 2 (VPA 2), and Vancomycin 2 (VANC 2) methods on the ADVIA Chemistry Systems.
ADVIA Chemistry TDM DRUG Calibrator II is a multi-analyte, liquid, bovine serum based product containing multiple analytes. The kit consists of 2 vials of each of 5 calibrator levels which are ready for use (no preparation is required). The volume per vial is 5.0 mL. Tobramycin, Carbamazepine, Valproic Acic, Vancomycin and Gentamicin analytes are value assigned for ADVIA Chemsitry systems.
The provided document is a 510(k) summary for a calibrator device, not a diagnostic device that performs human-in-the-loop analysis or has complex acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, or AUC. Therefore, many of the typical questions for diagnostic devices, especially those involving AI or human readers, are not applicable.
This document describes a submission for demonstrating substantial equivalence of a new calibrator (ADVIA Chemistry DRUG Calibrator II) to a previously cleared predicate calibrator (Dade Behring Dimension Drug Calibrator II). The core of the study is a comparison of characteristics between the new and predicate devices to show they are fundamentally the same for their intended use.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a diagnostic performance study. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device. The comparison table below highlights the key characteristics that were evaluated to demonstrate this equivalence. The "performance" is that these characteristics are largely identical or comparable.
| Characteristic | Acceptance/Equivalence Criteria (Implicit) | Reported Device Performance (ADVIA Chemistry TDM Drug II Calibrator) |
|---|---|---|
| Intended Use | For in vitro diagnostic use in the calibration of specific therapeutic drug monitoring (TDM) methods on chemistry systems. (Slight variations in specific analytes calibrated are noted but overall purpose is equivalent). | For in vitro diagnostic use in the calibration of Carbamazepine_2 (CARB_2), Gentamicin_2 (GENT_2), Tobramycin_2 (TOBR_2), Valproic Acid_2 (VPA_2), and Vancomycin_2 (VANC_2) methods on ADVIA Chemistry systems. |
| Formulation/Analytes Present | Similar set of analytes for TDM, often with overlapping crucial components. | Carbamazepine, gentamicin, tobramycin, valproic acid, vancomycin. |
| Measured Analytes (value assigned) | Similar TDM analytes for which values are assigned. | Carbamazepine (CARB_2), Gentamicin (GENT_2), Tobramycin (TOBR_2), Valproic Acid_2 (VPA_2), Vancomycin (VANC_2). |
| Form | Liquid. | Liquid. |
| Traceability | USP standards. | USP. |
| Matrix | Bovine serum-based. | Bovine. |
| Number of Levels | Five calibrator levels. | Five. |
| Packaging | Ten vials: two vials at five levels (5.0 mL each). | Ten vials: two vials at five levels (5.0 mL each). |
| Stability | Similar shelf-life and open-vial stability. | 12 months shelf-life, 30 days open vial. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of clinical samples or patient data being analyzed by the device. The "study" here is a comparison of the characteristics of the new calibrator against a predicate calibrator. The "data provenance" refers to the characteristics and specifications of the calibrator products themselves.
The comparison is based on the inherent properties of the calibrators (e.g., active ingredients, matrix, form, stability specifications) rather than a performance study on a specific dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "test set" of clinical cases or images to establish ground truth from experts. The "ground truth" for a calibrator relates to the accuracy of the assigned values of the analytes within the calibrator, which would be established through a rigorous manufacturing and quality control process using recognized reference methods and standards (like USP Traceability mentioned).
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for a calibrator device, not a diagnostic device that would involve human readers or AI assistance in interpreting results for patient cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a calibrator, a component used to ensure the accuracy of other diagnostic methods (ADVIA Chemistry Systems). It does not involve algorithms or standalone performance analysis in the sense of a diagnostic test. Its performance is tied to its stability and the accuracy of its assigned values, which are verified through manufacturing and quality control.
7. The Type of Ground Truth Used
The "ground truth" for a calibrator typically refers to the certified or assigned values of the analytes within the calibrator itself. This is established through:
- Reference standards: The document states "USP Traceability," indicating that the analyte concentrations are traceable to United States Pharmacopeia reference standards.
- Validated analytical methods: High-precision and accurate analytical methods are used during manufacturing to determine the precise concentration of each analyte in the calibrator levels.
- Quality control processes: Extensive quality control ensures that each batch of calibrators meets the specified concentration ranges.
8. The Sample Size for the Training Set
Not applicable. "Training set" is a concept for machine learning algorithms or AI, which is not relevant to a chemical calibrator device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.