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K Number
K024038
Device Name
N LATEX IGA
Manufacturer
DADE BEHRING, INC.
Date Cleared
2003-02-13

(69 days)

Product Code
CZP
Regulation Number
866.5510
Type
Traditional
Panel
IM
Reference & Predicate Devices
K993549
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

In vitro diagnostic reagents for the quantitative determination of IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgA aids in the evaluation of the patient's immune system.

Device Description

Polystyrene latex particles coated with specific antibodies to human IgA are agglutinated when mixed with samples containing IgA. The intensity of scattered light in the BN™ Systems depends on the IgA concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the N Latex IgA device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implicit)Reported Device Performance
Correlation with Predicate Device: The device should show strong correlation with the legally marketed predicate device (Beckman Coulter IMMAGE® Immunochemistry System IGALC assay) for quantitative determination of IgA in human CSF and serum samples.Correlation (N Latex IgA vs. Predicate):
  • CSF (n=50): Slope = 1.008, Intercept = -0.324, Correlation Coefficient = 0.991
  • Serum (n=50): Slope = 1.123, Intercept = -0.067, Correlation Coefficient = 0.992
  • Serum/CSF Ratio (n=50): Slope = 0.910, Intercept = -0.146, Correlation Coefficient = 0.988 |

Note: The document explicitly states the N Latex IgA is "substantially equivalent in intended use and results obtained to the IMMAGE® IGALC assay." The provided "Device Performance Characteristics" table directly reports the correlation metrics (slope, intercept, and correlation coefficient) as evidence of this equivalence, implying these values met the internal acceptance criteria for demonstrating substantial equivalence. Excellent correlation coefficients (all above 0.98) and slopes close to 1.0, with small intercepts, typically indicate strong agreement between two measurement methods.

Study Details:

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

    • Sample Size:
      • CSF: 50 samples
      • Serum: 50 samples
      • Serum/CSF Ratio: 50 samples (presumably derived from the same CSF and Serum samples)
    • Data Provenance: Not explicitly stated (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:

    • The concept of "ground truth" established by experts is not applicable here as this is a quantitative diagnostic device comparing its performance to a predicate device.
    • The "ground truth" in this context is the quantitative result obtained from the legally marketed predicate device (Beckman Coulter IMMAGE® Immunochemistry System IGALC assay).

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable. This is a comparison between a new device and a predicate device, not an interpretation task requiring adjudication of expert opinions.

  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 a study comparing a new diagnostic device's quantitative measurements to an existing predicate device, not an MRMC study involving human readers or AI assistance.

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

    • Yes, this was a standalone performance evaluation. The N Latex IgA device (an in vitro diagnostic reagent system) was tested to determine its quantitative output for IgA, and these outputs were then correlated with results from a predicate device. There is no human-in-the-loop component described for the measurement process itself, although human operators would run the tests.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • The "ground truth" for this study was the quantitative IgA measurements obtained from the legally marketed predicate device, the Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) assay (K993549).

  7. The sample size for the training set:

    • Not applicable. This document describes a performance evaluation for regulatory submission, not the development or training of an algorithm in the machine learning sense. The device is a "particle-enhanced immunonephelometry system," which relies on biochemical reactions and optical detection, not a machine learning model that requires a training set.

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

    • Not applicable, as there is no "training set" in the context of this type of diagnostic device.

§ 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).