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510(k) Data Aggregation

    K Number
    K243489
    Device Name
    Alinity m EBV (09N43-095)
    Manufacturer
    Abbott Molecular Inc.
    Date Cleared
    2025-07-28

    (258 days)

    Product Code
    QLX
    Regulation Number
    866.3183
    Type
    Traditional
    Panel
    Microbiology (MI)
    Reference & Predicate Devices
    K212778
    Why did this record match?
    Device Name :

    Alinity m EBV (09N43-095)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Epstein-Barr Virus (EBV) DNA in human EDTA plasma on the automated Alinity m System.

    Alinity m EBV is intended for use as an aid in the management of EBV in transplant patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment.

    The results from Alinity m EBV must be interpreted within the context of all relevant clinical and laboratory findings.

    Alinity m EBV is not cleared for use as a screening test for donors of blood, blood products, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for EBV.

    Device Description

    Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of EBV DNA in human plasma.

    This device is similar to the predicate device originally cleared (K212778) with the exception that the subject device may use MomentaTaq DNA Polymerase as an alternative to KAPA2G DNA Polymerase in the reagent formulation of the assay. This formulation difference does not introduce any changes to sample processing, assay procedure, or data reduction.

    Additional studies were initiated to support the formulation of the assay with MomentaTaq DNA Polymerase. Supplemental data from these studies were used with data previously obtained from the analytical and clinical testing studies submitted in K212778.

    The steps of the Alinity m EBV consist of sample preparation, real-time PCR assembly, amplification/detection, result calculation, and reporting. All stages of the Alinity m EBV procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m EBV assay in parallel with other Alinity m assays on the same instrument.

    Alinity m EBV requires three separate assay specific kits as follows:

    • Alinity m EBV AMP Kit (List No. 09N43-095), consisting of 2 types of multi-well assay trays. The amplification trays (AMP TRAY 1) contain lyophilized, unit-dose PCR amplification/detection reagents and lyophilized, unit-dose IC in separate wells, and the activation trays (ACT TRAY 2) contain liquid unit-dose activation reagent. The intended storage condition for the Alinity m EBV AMP Kit is 2°C to 8°C.

    • Alinity m EBV CTRL Kit (List No. 09N43-085), consisting of negative controls, low positive controls, and high positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m EBV CTRL Kit is –25°C to –15°C.

    • Alinity m EBV CAL Kit (List No. 09N43-075), consisting of 2 calibrator levels, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m EBV CAL Kit is –25°C to –15°C.

    EBV DNA from human plasma is extracted automatically on-board in the Alinity m System using the Alinity m Sample Prep Kit 2, Alinity m Lysis Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with liquid unit-dose Alinity m EBV activation reagent and lyophilized unit-dose Alinity m EBV amplification/detection reagents and transferred into a reaction vessel. Alinity m Vapor Barrier Solution is then added to the reaction vessel which is then transferred to an amplification/detection unit for PCR amplification, and real-time fluorescence detection of EBV targets.

    At the beginning of the Alinity m EBV sample preparation process, a lyophilized unit-dose IC on the AMP Tray is rehydrated by the Alinity m System and delivered into each sample preparation reaction. The IC is then processed through the entire sample preparation and real-time PCR procedure along with the specimens, calibrators, and controls to demonstrate proper sample processing and validity.

    The Alinity m EBV amplification/detection reagents consist of enzymes, primers, probes, and activation reagents that enable polymerization and detection.

    An EBV calibration curve is required for determination of EBV DNA concentration. Two levels of calibrators are processed through sample preparation and PCR to generate the calibration curve. The concentration of EBV DNA in specimens and controls is then calculated from the stored calibration curve.

    Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remains satisfactory. During each control event, a negative control, a low-positive control, and a high-positive control are processed through sample preparation and PCR procedures that are identical to those used for specimens.

    The Alinity m EBV assay also utilizes the following:

    • Alinity m EBV Application Specification File, (List No. 09N43-05B)
    • Alinity m System and System Software (List No. 08N53-002)
    • Alinity m Sample Prep Kit 2 (List No. 09N12-001)
    • Alinity m Specimen Dilution Kit I (List No. 09N50-001)
    • Alinity m System Solutions, (List No. 09N20):
      • Alinity m Lysis Solution (List No. 09N20-001)
      • Alinity m Diluent Solution (List No. 09N20-003)
      • Alinity m Vapor Barrier Solution, (List No. 09N20-004)
    • Alinity m Tubes and Caps (List No. 09N49):
      • Alinity m LRV Tube (List No. 09N49-001)
      • Alinity m Transport Tubes Pierceable Capped (List No. 09N49-010)
      • Alinity m Transport Tube (List No. 09N49-011)
      • Alinity m Pierceable Cap (List No. 09N49-012)
      • Alinity m Aliquot Tube (List No. 09N49-013)
    AI/ML Overview

    This document, K243489, is a 510(k) clearance letter for the Alinity m EBV assay, specifically focusing on the use of MomentaTaq DNA Polymerase as an alternative to KAPA2G DNA Polymerase. The primary goal of the studies described is to demonstrate that the device formulated with MomentaTaq DNA Polymerase performs equivalently to the previously cleared device formulated with KAPA2G DNA Polymerase (K212778).

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria with MomentaTaq Formulation (Implicitly compared to KAPA2G performance)Reported Device Performance (MomentaTaq Formulation)
    Limit of Detection (LoD)Overall detection rate of ≥ 95% at 20 IU/mL (based on previous clearance of K212778).Overall detection rate of 97.2% at 20 IU/mL.
    Linear RangeLinear across 50 IU/mL (1.70 Log IU/mL) to 200,000,000 IU/mL (8.30 Log IU/mL).Linear across 15 IU/mL to 250,000,000 IU/mL (1.18 Log IU/mL to 8.40 Log IU/mL).
    Precision (Within-laboratory SD)≤ 0.25 Log IU/mL for 500 IU/mL to 200,000,000 IU/mL (2.70 Log IU/mL to 8.30 Log IU/mL).Achieved for all panels in this range (0.06-0.19 Log IU/mL).
    Precision (Within-laboratory SD)≤ 0.50 Log IU/mL for 20 IU/mL to
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