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K Number
K032251
Device Name
IMMUNETECH TOTAL IGE SYSTEM
Manufacturer
IMMUNETECH CORPORATION
Date Cleared
2003-12-19

(150 days)

Product Code
DGC
Regulation Number
866.5510
Type
Traditional
Panel
IM
Reference & Predicate Devices
K020387,K991945
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system that measures total IgE in human serum. The ImmuneTech™ Total IgE System is intended for clinical laboratory use. The ImmuneTech™ Total IgE System may only be run on the Luminex 100TM Integrated System.

The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system used as an aid in the clinical diagnosis of IgE mediated allergic disorders.

Device Description

ImmuneTech™ Total IgE System is a test for the measurement of total IgE in human serum. The ImmuneTech™ Total IgE System consists of two components.

    1. Flow Cytometer instrument with software for ImmuneTech™ Total IgE System
    1. ImmuneTech™ Total IgE System Reagents

A serum sample is mixed with anti-IgE coupled microspheres. If present, IgE in the sample will bind with the microspheres and form an anti-human IgE / IgE complex. This complex is then sequentially incubated with biotin-labeled-anti-human IgE antibody and fluorescent-labeled-streptavidin. If IgE is present in the sample, the final sandwich complex of anti-human IgE / IgE / biotin-anti IgE / fluorescent-streptavidin will form. Measurement of the fluorescent signal from the sandwich complex is directly proportional to the concentration of total IgE in the sample. The flow cytometer with ImmuneTech ™ Total IgE System specific software will measure total IgE concentrations.

AI/ML Overview

This summarizes the acceptance criteria and study details for the ImmuneTech™ Total IgE System, based on the provided 510(k) summary.

I. Acceptance Criteria and Reported Device Performance

Performance MetricAcceptance Criteria (Implied)Reported Device Performance (ImmuneTech™ Total IgE System)
Method ComparisonHigh correlation to predicateCorrelation Coefficient 0.97; y=1.00x+6.03
SensitivityLow detection limit2 IU/mL
SpecificityNo cross-reactivityNon cross reactive to IgG, IgA or IgM
RecoveryHigh recovery rate99.8%
Between Day Precision (CV)Low variability3-10%
Within Day Precision (CV)Low variability2-9%

II. Study Details

  1. Sample size used for the test set and the data provenance:

    • The document does not explicitly state the specific sample size for the test set.
    • The data provenance is not specified (e.g., country of origin, retrospective or prospective).

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. The ground truth for this in vitro diagnostic device is based on analytical performance metrics (e.g., comparison to a predicate device, known concentrations for sensitivity, specificity, and recovery).

  3. Adjudication method for the test set:

    • Not applicable. This is an in vitro diagnostic device assessing analytical performance, not a diagnostic imaging or clinical judgment study requiring expert adjudication.

  4. 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:

    • No. This is an in vitro diagnostic system, not a device that involves human readers or AI assistance in interpretation in the context of an MRMC study.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Yes, at least in part. The studies evaluating "Method Comparison, Sensitivity, Specificity, Accuracy (recovery) and Precision" describe the analytical performance of the ImmuneTech™ Total IgE System itself, independent of human interpretation. While the system operates on a flow cytometer, the reported performance metrics focus on the device's ability to measure IgE concentrations directly.

  6. The type of ground truth used:

    • The ground truth appears to be established through:
      • Comparison to a legally marketed predicate device: "MyAllergyTest™ System" and "Pharmacia CAP System IgE FEIA" were used as comparators for method comparison.
      • Known concentrations/samples: For sensitivity, specificity, recovery, and precision studies, it is implied that samples with known IgE concentrations or characteristics (e.g., non-atopic vs. atopic individuals, samples without cross-reacting substances) were used.

  7. The sample size for the training set:

    • Not specified. The document does not mention details about a training set, as this typically applies more to machine learning algorithms, which are not explicitly detailed here beyond the software component. The performance data focuses on analytical validation.

  8. How the ground truth for the training set was established:

    • Not applicable, as a training set and its ground truth establishment are not discussed in the provided summary.

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).