(76 days)
The CEDIA® Vancomycin Assay is a homogenous enzyme immunoassay intended for in vitro diagnostic use in the quantitative determination of vancomycin in human serum or plasma for the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
The CEDIA® Vancomycin Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive 8-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.
The provided text is a 510(k) summary for the CEDIA® Vancomycin Assay, a diagnostic device. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific performance acceptance criteria through a dedicated study with the information requested. Therefore, much of the requested information is not available in the provided document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics (like accuracy, precision, limits of detection). Instead, it focuses on demonstrating substantial equivalence to a predicate device based on intended use and physical properties.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (Summary of Equivalence) |
|---|---|---|
| Intended Use | Equivalent to predicate (quantitative determination of vancomycin in human serum/plasma for diagnosis/treatment of overdose and monitoring therapy) | The CEDIA® Vancomycin Assay has an identical intended use to the predicate device. |
| Analyte | Vancomycin | Vancomycin |
| Matrix | Serum or plasma | Serum or plasma |
| Calibrator Form | Not explicitly defined, but predicate uses liquid. | Liquid |
| Calibrator Levels | Not explicitly defined, but predicate uses 6 levels. | Two (2) Levels (0 and 50 µg/mL) - Note: This is a characteristic difference, but deemed substantially equivalent. |
| Storage | 2°C to 8°C until expiration date | 2°C to 8°C until expiration date |
| Stability | Until expiration date on vial label | Until expiration date on vial label and Package Insert for Kit and reconstituted reagents. |
| Principle of Use | Homogeneous enzyme immunoassay | Homogeneous enzyme immunoassay |
The "study that proves the device meets the acceptance criteria" is implicitly the comparison to the predicate device (Abbott AxSYM® Vancomycin II, K955851). The 510(k) process relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials to establish de novo performance criteria. The summary states: "The information provided in this pre-market notification demonstrates that the CEDIA® Vancomycin Assay is substantially equivalent to the Abbott AxSYM® Vancomycin II assay, the previously cleared predicate device (K955851). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device."
2. Sample size used for the test set and the data provenance
The document does not provide specific details on a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in the more comprehensive study reports or validation data submitted to the FDA, which are not part of this 510(k) summary. The summary focuses on comparing the new device's characteristics and intended use to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. Given that this is an in vitro diagnostic (IVD) device for quantitative measurement, the "ground truth" would likely be established through reference methods (e.g., HPLC-MS) rather than expert consensus on images or interpretations.
4. Adjudication method for the test set
This information is not provided in the 510(k) summary. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiology) to resolve discrepancies. For a quantitative IVD, the "adjudication" would be related to statistical analysis and agreement with reference methods.
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
An MRMC study is not applicable to this device. This is a quantitative immunoassay for vancomycin concentration, not an AI-assisted diagnostic imaging device requiring human readers or interpretation improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the typical sense for this type of IVD. The device itself performs the quantitative measurement. Its "standalone" performance would be its analytical performance (accuracy, precision, linearity, etc.), which would have been part of the validation studies submitted to the FDA but is not detailed in this 510(k) summary.
7. The type of ground truth used
The ground truth for a quantitative immunoassay like the CEDIA® Vancomycin Assay would typically be established by a reference method (e.g., liquid chromatography-mass spectrometry (LC-MS)) or well-characterized control samples with known vancomycin concentrations, rather than expert consensus, pathology, or outcomes data in the usual sense. The summary does not explicitly state the specific reference method used for validation studies.
8. The sample size for the training set
This information is not provided in the 510(k) summary. For an enzyme immunoassay, the "training set" would refer to samples used during the assay development and optimization phases to establish calibration curves, reagent formulations, and operating parameters. This is distinct from machine learning model training sets.
9. How the ground truth for the training set was established
This information is not provided in the 510(k) summary. Similar to item 7, the ground truth for samples used in development and optimization would have been established by reference methods or gravimetric preparation of standards.
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.