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510(k) Data Aggregation
(238 days)
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma.
For in vitro diagnostic use.
The ARCHITECT iVancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The antivancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (ARCHITECT iVancomycin vs. AxSYM Vancomycin II) |
|---|---|
| Substantial equivalence in terms of precision | Demonstrated substantial equivalence |
| Substantial equivalence in terms of linearity | Demonstrated substantial equivalence |
| Substantial equivalence in terms of interferences | Demonstrated substantial equivalence |
| High correlation for quantitative measurement of vancomycin | Correlation coefficient of 0.996 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the clinical performance comparison, nor does it specify the country of origin of the data or whether it was retrospective or prospective. It only states that a "Summary of Clinical Performance" demonstrated "substantially equivalent performance" with a correlation coefficient of 0.996.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in vitro diagnostic device for quantitative measurement of vancomycin in human serum or plasma. Ground truth is established by a reference method (the predicate device) or by the inherent accuracy of the chemical measurement itself, rather than by human expert consensus or clinical assessment.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or diagnostic interpretation tasks where human readers are involved. For an in vitro diagnostic device like this, the comparison is between the new device and a predicate device in terms of analytical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance assessment of the ARCHITECT iVancomycin assay. The device itself performs the quantitative measurement without human interpretation as part of its core function, although human operators are involved in running the assay. The comparison directly evaluates the device's analytical output against that of a predicate device.
7. The Type of Ground Truth Used
The ground truth or reference standard for evaluating the ARCHITECT iVancomycin assay's performance was the AxSYM Vancomycin II assay, which is the legally marketed predicate device. The clinical performance summary indicates a direct comparison of results between the new device and the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is an immunoassay, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a system involves the development and optimization of the reagent formulations, reaction conditions, and calibration procedures, which are determined during the device development phase, not through a "training set" of patient data as in machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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