(26 days)
The CEDIA Antibiotic TDM Multi-Cals are used to calibrate the CEDIA assays for tobramycin and gentamicin in human serum and plasma.
The CEDIA Antibiotic TDM Calibrators are manufactured using bovine serum albumin, tobramycin, gentamicin, stabilizers, and preservatives. The drugs are appropriately spiked into the calibrator matrix to 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 been value assigned by comparison to the
This document describes a 510(k) Summary for CEDIA Antibiotic TDM Multi-Cals, which are calibrators for tobramycin and gentamicin assays. The summary focuses on establishing substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, many of the requested categories (such as AI improvement, standalone performance, training set details, and expert adjudication) are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantially equivalent correlation between the new CEDIA Antibiotic TDM Multi-Cals and the kit calibrators of existing CEDIA tobramycin and gentamicin assays (predicate devices).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent correlation between predicate device kit calibrators and new calibrators (for tobramycin and gentamicin assays) | Method Comparison: "equivalent correlation between predicate device kit calibrators and CEDIA Antibiotic TDM Multi-Cals." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5." However, the provided text does not include the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective study design).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This concept is not applicable to this type of device (calibrators). The "ground truth" for calibrators is typically established by precise chemical or analytical methods, not by expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable for this type of device. Adjudication methods are relevant for human interpretation of clinical data, not for calibrator performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, this is not an AI/ML powered device. An MRMC study would not be relevant in this context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a set of calibrators, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the calibrators themselves is established by precise chemical spiking and value assignment. The document states: "The drugs are appropriately spiked into the calibrator matrix to 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 been value assigned by comparison to the..." (the sentence is cut off, but implies a reference method).
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device does not have a training set.
§ 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.