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K Number
K955851
Device Name
AXSYM VANCOMYCIN II
Manufacturer
ABBOTT LABORATORIES
Date Cleared
1996-05-09

(134 days)

Product Code
LEH
Regulation Number
862.3950
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

for the quantitative determination of vancomycin in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).

Device Description

automated fluorescence polarization immunoassays (FPIA).

AI/ML Overview

K955851: Abbott AxSYM® Vancomycin II - Acceptance Criteria and Study Details

This 510(k) summary focuses on demonstrating substantial equivalence of the AxSYM Vancomycin II assay to the previously cleared AxSYM Vancomycin assay. Therefore, the "acceptance criteria" here are implicitly related to the correlation between the two assays. The "study" described is a correlation study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance CriteriaReported Device PerformanceComments
Implicit Criteria: Correlation between AxSYM Vancomycin II and AxSYM Vancomycin assays.The exact numerical acceptance criteria are not explicitly stated. However, strong correlation coefficients and slopes close to 1 are generally accepted for demonstrating substantial equivalence between two similar assays.
Slope close to 11.03Indicates a good linear relationship.
Y-Intercept close to 0-1.08Indicates minimal systematic bias.
High Correlation Coefficient (R)0.99Very strong positive linear relationship, suggesting excellent agreement.
Low Standard Error of the Y estimate2.74Measures the average distance that the observed values fall from the regression line, indicating precision of the prediction. A lower value suggests better precision.

2. Sample Size and Data Provenance

  • Sample Size for Test Set: 217
  • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic device, it is highly likely that the data was collected prospectively in a controlled laboratory setting (e.g., within Abbott Laboratories or collaborating clinical sites) to specifically evaluate the new assay.

3. Number of Experts and Qualifications for Ground Truth

  • Not Applicable. This study is a correlation study comparing two automated assays against each other, not against a "ground truth" established by human experts in a diagnostic context. The "ground truth" here is effectively the performance of the predicate device (AxSYM Vancomycin assay).

4. Adjudication Method for the Test Set

  • Not Applicable. As this is a correlation study between two automated assays, there is no human adjudication process involved in establishing the "correct" values for individual samples. The comparison is purely statistical.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

  • No. This is not an MRMC study. MRMC studies are typically used to evaluate the impact of an AI algorithm on human reader performance, often in image-based diagnostics. This submission describes a correlation study for an in-vitro diagnostic device.

6. Standalone Performance Study

  • Yes (for the correlation aspect). The reported metrics (Slope, Y-Intercept, Correlation Coefficient, Std. Error of the Y estimate) are measures of the standalone performance of the AxSYM Vancomycin II assay relative to the AxSYM Vancomycin assay. This study demonstrates the equivalence of the new algorithm (AxSYM Vancomycin II) to the existing one in terms of quantitative results. It's important to note this isn't a standalone performance against a "true" vancomycin concentration from an independent method, but rather against a validated predicate device.

7. Type of Ground Truth Used

  • The "ground truth" in this context is the results obtained from the predicate device, the Abbott AxSYM Vancomycin assay. The study aims to show that the new AxSYM Vancomycin II assay produces results that are substantially equivalent to the established AxSYM Vancomycin assay.

8. Sample Size for the Training Set

  • Not explicitly stated in this summary. The document describes a "correlation study" with a sample size of 217, which serves as the test set for demonstrating equivalence. Information regarding a separate "training set" for the AxSYM Vancomycin II algorithm development is not provided in this summary. It's common for such information to be in other sections of the 510(k) submission if the device employed a trainable algorithm. However, for a fluorescence polarization immunoassay, the "algorithm" is often based on well-established chemical kinetics and calibration curves rather than machine learning requiring a separate training set in the modern sense.

9. How the Ground Truth for the Training Set Was Established

  • Not applicable / Information not provided in this summary. As mentioned above, a specific "training set" with separate ground truth establishment is not detailed. The "ground truth" for the overall development and calibration of such an assay would typically involve:
    • Purified material obtained from commercial sources: Used for preparing calibrators and controls.
    • Gravimetric preparation: Ensuring accurate concentrations of calibrators and controls.
    • Multiple instrument testing: Verification of calibrators and controls, implying a robust internal validation process.

§ 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.