LogoFDA 510(k) Search
K Number
K974111
Device Name
QUIDEL CH50 EQ EIA
Manufacturer
QUIDEL CORP.
Date Cleared
1998-07-29

(271 days)

Product Code
DAE
Regulation Number
866.5240
Type
Traditional
Panel
Immunology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The QUIDEL CH50 Eq EIA intended to measure the total classical complement pathway activity in human serum, thereby allowing detection of a deficiency of one or more of the complement components C1 through C9. The QUIDEL CH50 Eq EIA is intended for laboratory and professional use.

Device Description

The QUIDEL CH50 Eq EIA provides a direct measure of the total classical complement activity in serum by quantifying the amount of TCC generated under standard conditions. The test uses a monoclonal antibody to a unique neoantigen to capture the TCC analyte. Since both the QUIDEL CH50 Eq EIA and the CH50 test rely on the generation of TCC and correlate, the QUIDEL CH50 Eq EIA's results are expressed in CH50 unit equivalents per milliliter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the QUIDEL CH50 Eq EIA, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance CriterionReported Device PerformanceComments
Overall AccuracyGreater than 97%Compared to the combined results from three hemolytic and one EIA-based assay.
Intra-assay precisionGoodSpecific metrics (e.g., CV%) not provided, but stated as "good".
Inter-assay precisionGoodSpecific metrics (e.g., CV%) not provided, but stated as "good".
Lot-to-lot consistencyReproducibly manufacturableConfirmed with "Lot-to-lot consistency analyses".
InterferencePotentially interfering substances were shown not to interfere with the test's performance.No specific interfering substances or their concentrations cited.
Similarity to other commercially available testsSimilar in terms of features and intended use.This is a qualitative assessment of substantial equivalence.
Stability/Shelf-lifeUnderwayStability studies were ongoing at the time of submission.

Study Details

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

    • Sample Size: 226 patient samples.
    • Data Provenance: Tested at a "major clinical reference laboratory in the United States." The samples were likely retrospective, though not explicitly stated as such.

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

    • The document does not specify the number of experts or their qualifications for establishing ground truth.
    • The ground truth was established by "the combined results from three hemolytic and one EIA-based assay," rather than expert consensus on individual cases.

  3. Adjudication method for the test set:

    • Not applicable directly. Ground truth was established by comparing the QUIDEL CH50 Eq EIA results against a combination of reference assays, not by human adjudication of individual cases.

  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 study is for an in-vitro diagnostic (IVD) device (an EIA assay) that directly measures an analyte. It does not involve human readers or AI in the interpretation of images or other subjective data, so an MRMC study is not relevant here.

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

    • Yes, effectively. The "overall accuracy" of the QUIDEL CH50 Eq EIA "when compared to the combined results from three hemolytic and one EIA-based assay" demonstrates its standalone analytical performance. The device is intended for laboratory and professional use, implying a human operator performs the test and interprets the result, but the accuracy measurement itself is of the device's output.

  6. The type of ground truth used:

    • Comparative Reference Assays: The ground truth was established by the "combined results from three hemolytic and one EIA-based assay." These are established laboratory methods for measuring total classical complement activity.

  7. The sample size for the training set:

    • The document does not indicate a separate "training set" or its size. For an IVD assay like this, development typically involves optimizing reagents and protocols during analytical validation, rather than distinct training and test sets in the machine learning sense. The 226 patient samples can be considered the core clinical validation dataset.

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

    • As no explicit training set is identified, this question is not directly applicable. If developmental work used samples, the ground truth would have likely been established through similar reference methods to those used for the test set, or through known healthy/diseased donor samples.

§ 866.5240 Complement components immunological test system.

(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).