(67 days)
The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
Serum or plasma is mixed with Reagent 1, which contains vancomycin labeled with the enzyme glucose-6-phosphate dehydrogenase (G6)DH). Subsequently, Reagent 2, which contains antibodies to vancomvcin and the coenzyme nicotinamide adenine dinucleotide (NAD), is added. Vancomycin in the sample and vancomycin-labeled G6PDH compete for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the vancomycin concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized NAD to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
Here's a breakdown of the acceptance criteria and the study details for the Dade Behring Inc. Emit® 2000 Vancomycin Assay, based on the provided 510(k) notification:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation | 0.99 |
| Slope | 0.96 |
| Intercept | -0.12 µg/dL |
Note: The acceptance criteria themselves are implied by the comparison to the predicate device. The stated performance metrics of the Emit® 2000 Vancomycin Assay in comparison to the predicate exceed typical internal acceptance thresholds for linearity and correlation in quantitative assays (e.g., correlation coefficient often expected to be >0.95 or >0.98, slope close to 1, and intercept close to 0).
Study Details
-
Sample Size used for the test set and the data provenance:
- Sample Size: 100 patient samples
- Data Provenance: Not explicitly stated, but the context of "patient samples" implies human biological samples. It's retrospective as it's a split sample comparison to an existing predicate.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The ground truth for this type of assay comparison is established by the measurements obtained from the predicate device (Emit® Vancomycin Assay, K881040), which itself would have undergone its own validation.
-
Adjudication method for the test set:
- Not applicable. This is a technical comparison of an in-vitro diagnostic device's quantitative output against a predicate device, not a diagnostic decision based on expert review.
-
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:
- Not applicable. This is not an AI-assisted diagnostic imaging or interpretation device. It's a quantitative chemical assay.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This study is a standalone performance evaluation of the Emit® 2000 Vancomycin Assay directly compared to a legally marketed predicate device. The assay itself operates without human intervention in the result generation, only in sample preparation and loading.
-
The type of ground truth used:
- The ground truth for this comparison study was established by the measurements obtained from the predicate device (Emit® Vancomycin Assay, K881040). The predicate device's performance characteristics served as the reference standard. The samples ranged from 5 to 50 µg/dL.
-
The sample size for the training set:
- Information on a separate "training set" is not provided as this is a traditional chemical assay validation for substantial equivalence, not a machine learning model. The development of the assay itself would have involved extensive R&D and optimization, but those details are not part of this 510(k) summary.
-
How the ground truth for the training set was established:
- Not applicable, as a distinct training set (in the context of machine learning) is not described. The assay's analytical performance is based on its chemical and enzymatic reactions, which were developed and characterized to accurately measure vancomycin concentration.
§ 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.