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Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Device Description

The Elecsys IgE II immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.

AI/ML Overview

The given document is a 510(k) summary for the Elecsys IgE II Immunoassay. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria or a dedicated study section detailing how the device met those criteria in the format typically used for AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to a previously approved device (Elecsys IgE Immunoassay, K984326, K961481/A003) for the purpose of 510(k) clearance. This means the assessment is primarily a device comparison rather than a standalone performance study against pre-defined acceptance criteria for a novel device.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission for an in vitro diagnostic (IVD) immunoassay, the "acceptance criteria" are implicitly met by demonstrating comparable performance to the predicate device across various analytical characteristics. There isn't a single table of "acceptance criteria" with pass/fail thresholds in the typical sense for AI/ML performance. Instead, the document presents comparative performance data to show the new device is "substantially equivalent" to the predicate.

The table below summarizes the key analytical performance characteristics presented in the document, comparing the Elecsys IgE II (Modified Device) to the predicate Elecsys IgE. The "acceptance criteria" here are effectively that the new device's performance should be comparable enough to the predicate to be considered substantially equivalent.

Performance Characteristic	Predicate Device (Elecsys IgE)	Elecsys IgE II (Modified Device)	"Acceptance Criteria" (Implicit for Substantial Equivalence)	Outcome
Intended Use	Immunoassay for IgE quantification in human serum and plasma; aid in diagnosis of allergic diseases.	Same	Functionally equivalent to predicate.	Met
Analyzers	Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170	Roche Elecsys 2010 and MODULAR ANALYTICS E170	Compatible with similar clinical analyzer platforms.	Met
Traceability	Standardized against 2nd IRP WHO Reference Standard 75/502	Same	Same standardization as predicate.	Met
Assay Protocol	Sandwich	Same	Same assay principle.	Met
Sample Type	Serum and plasma	Same	Same clinical utility.	Met
Calibrator, Calibration Verification & Controls	IgE CalSet, IgE CalCheck, PreciControl Universal	Same	Uses same calibration materials and controls.	Met
Measuring Range	0.10 - 2500 IU/mL	Same	Same analytical range.	Met
Analytical Sensitivity	0.10 IU/mL	Same	Same lower limit of detection.	Met
Functional Sensitivity	0.50 IU/ml	Same	Same functional lower limit.	Met
Composition	R1: 2.4 mg/L AB-Bi, buffer, preservative; R2: 4.8 mg/L AB-Ru, buffer, preservative; M: 0.72 mg/ml streptavidin-coated microparticles, preservative	R1: 2.5 mg/L (mono-Bi)AB-Bi, buffer, preservative; R2: 5.5 mg/L AB-Ru, buffer, preservative; M: 0.72 mg/ml streptavidin-coated microparticles, preservative	Minor compositional changes that do not alter fundamental performance.	Met
Dilution Recommendation	> 60 IU/mL	> 125 IU/mL	Acceptable adjustment based on method validation.	Met
Interferences (Bilirubin)	No affect up to 37 mg/dl	Same	Comparable resistance to common interferents.	Met
Interferences (Hemoglobin)	No affect up to 1.1 g/dl	No affect up to 0.1 g/dl	While the value is different, the FDA found it acceptable for substantial equivalence.	Met
Interferences (Triglycerides)	No affect up to 2200 mg/dl	Same	Comparable resistance to common interferents.	Met
Interferences (Biotin)	No affect up to 100 ng/ml	Same	Comparable resistance to common interferents.	Met
Precision (Elecsys 2010 Intra-assay CV)	HS1 3.6% @ 5.18 IU/mL; HS2 3.2% @ 398 IU/mL; HS3 2.4% @ 1010 IU/mL	HS1 4.1% @ 32.7 IU/mL; HS2 2.4% @ 265 IU/mL; HS3 2.6% @ 1295 IU/mL	Comparable precision performance.	Met
Precision (Elecsys 2010 Total CV)	HS1 4.2% @ 5.18 IU/mL; HS2 3.9% @ 398 IU/mL; HS3 3.1% @ 1010 IU/mL	HS1 5.1% @ 32.7 IU/mL; HS2 3.8% @ 265 IU/mL; HS3 3.9% @ 1295 IU/mL	Comparable precision performance.	Met
Precision (E170 Intra-assay CV)	HS1 2.3% @ 3.36 IU/mL; HS2 2.2% @ 457 IU/mL; HS3 2.6% @ 1128 IU/mL	HS1 1.4% @ 4.4 IU/mL; HS2 0.7% @ 261 IU/mL; HS3 1.0% @ 1018 IU/mL	Comparable precision performance.	Met
Precision (E170 Total CV)	HS1 4.3% @ 3.31 IU/mL; HS2 3.8% @ 443 IU/mL; HS3 6.5% @ 1215 IU/mL	HS1 2.7% @ 30.2 IU/mL; HS2 2.8% @ 245 IU/mL; HS3 3.4% @ 1207 IU/mL	Comparable precision performance.	Met

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Performance): The document does not explicitly present a "test set" in the context of clinical performance data in the way an AI/ML device would. Instead, it compares analytical performance characteristics (sensitivity, measuring range, precision, interference) of the new device against the predicate.
- For precision studies, the data points represent multiple measurements ("HS1", "HS2", "HS3" at different IgE concentrations) for intra-assay and total variation. The exact number of individual patient samples or replicates used to derive these CVs is not specified in the summary, but typical precision studies involve multiple runs over several days.
- For interference studies, it indicates "No affect up to," implying specific concentrations of potential interferents were tested. The number of samples or replicates used for these tests is not specified.
Data Provenance: Not explicitly stated, but for IVD assays, analytical performance studies are typically conducted by the manufacturer in a controlled laboratory setting. It's likely a mix of internal validation studies, and possibly some external site testing, but specific countries or retrospective/prospective nature is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of IVD immunoassay submission. The "ground truth" for analytical performance studies is based on established laboratory measurement techniques, reference standards (like WHO Reference Standard 75/502 for IgE), and accepted statistical methods for evaluating precision, sensitivity, etc. There are no "experts" establishing a subjective ground truth for image interpretation or diagnosis in this context.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is an analytical performance assessment, not a clinical adjudication of diagnostic outcomes by human readers.

5. 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

Not applicable. This device is an in vitro diagnostic immunoassay, not an AI/ML diagnostic aid intended to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study is not relevant.

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

Not applicable. The device is a laboratory instrument and reagent system that quantitatively measures IgE. Its performance is inherent to the assay and instrument, and it operates without human intervention in the result generation itself, but a lab technician operates the instrument. It is not an "algorithm" in the AI/ML sense.

7. The Type of Ground Truth Used

The ground truth for the performance characteristics presented (e.g., measuring range, analytical sensitivity, functional sensitivity, precision) is based on:

Reference Standards: Specifically, the 2nd IRP WHO Reference Standard 75/502 for IgE.
Defined Analytical Methods: The quantitative measurement of IgE following standardized laboratory procedures.
Statistical Analysis: Metrics like Coefficient of Variation (CV) for precision are derived from repeated measurements using established statistical methods.

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for this type of immunoassay.

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K Number

K984326

Device Name

ELECYS IGE ASSAY

Manufacturer

BOEHRINGER MANNHEIM CORP.

Date Cleared

1999-02-08

(67 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K061970

Intended Use

For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the diagnosis of allergic disease.

Device Description

The Elecsys® IgE test is based on the sandwich principle of heterogeneous immunological complex formation. First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled antibodies (R2), both specific for IgE, bind IgE present in the sample forming a sandwich complex Second Step: Microparticles coated with streptavidin (M) bind the biotin portion of the complex and are captured magnetically onto the surface of the electrode. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Elecsys® IgE Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Implied / Predicate Performance)	Reported Device Performance (Elecsys® IgE Test)
Precision		Within-Run %CV
	Within-Run %CV: ~2.1% at 102.7 IU/mL ~2.1% at 244.1 IU/mL ~2.8% at 375.4 IU/mL	3.6% at 5.18 IU/mL 2.1% at 105 IU/mL 2.8% at 197 IU/mL 3.2% at 398 IU/mL 2.4% at 1010 IU/mL
	Total %CV	Total %CV
	Total %CV: ~3.4% at 102.7 IU/mL ~3.4% at 244.1 IU/mL ~3.6% at 375.4 IU/mL	4.2% at 5.18 IU/mL 1.9% at 105 IU/mL 3.9% at 197 IU/mL 3.9% at 398 IU/mL 3.1% at 1010 IU/mL
Lower Detection Limit	1.44 IU/mL (Predicate)	0.10 IU/mL
Measuring Range	1.44 - 500 IU/ml (Predicate)	0.10 - 4000 IU/ml
Specificity	No cross-reactions with IgG, IgA, and IgM (Predicate)	No cross-reactivity with the immunoglobulins G, A, and M was detected.
Method Comparison	Evidence of strong correlation (e.g., r close to 1) with the predicate device.	Elecsys IgE vs Enzymun-Test IgE Passing/Bablok: y = -0.53 + 0.97x, r = 1.0, SD (md68) = 2.42, N = 188 Linear regression: y = -1.85 + 1.01x, r = 1.0, Sy.x = 5.86, N = 188
Interfering Substances	No interference at predicate's concentrations: Bilirubin <64.5 mg/dL Hemoglobin <1 g/dL Lipemia <1250 mg/dL Biotin <100 ng/mL	No interference at: Bilirubin: <37 mg/dL Hemoglobin: <1.1 g/dL Lipemia: <2200 mg/dL Biotin: <100 ng/mL

Interpretation of Acceptance Criteria:

The acceptance criteria are generally established by comparison to a legally marketed predicate device. The Elecsys® IgE Test aims to demonstrate "substantial equivalence" to the Enzymun-Test® IgE. This means its performance characteristics should be comparable to or better than the predicate, and any differences should not raise new questions of safety or effectiveness.

Precision: The Elecsys® IgE Test shows comparable or slightly higher %CVs at some points compared to the predicate's reported precision, but also significantly lower %CVs at higher concentrations. The overall precision performance across a wider range of concentrations is provided.
Lower Detection Limit & Measuring Range: The Elecsys® device demonstrates a significantly improved lower detection limit and a substantially wider measuring range compared to the predicate, which would generally be seen as a positive improvement.
Specificity: Both devices report no cross-reactivity with other common immunoglobulins, meeting this criterion.
Method Comparison: The high correlation coefficients (r = 1.0) for both Passing/Bablok and Linear Regression indicate excellent agreement between the Elecsys® IgE Test and the predicate Enzymun-Test® IgE, demonstrating that the new device measures IgE levels similarly to the established method. The 'N = 188' indicates the sample size used for this comparison.
Interfering Substances: The Elecsys® IgE Test demonstrates non-interference at comparable or higher concentrations for some interfering substances (Hemoglobin, Lipemia) and a slightly lower threshold for Bilirubin, while matching the Biotin threshold of the predicate. This demonstrates robust performance in the presence of common interferents.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: For the method comparison study, N = 188 samples were used.
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It is implied to be data collected to characterize the performance of the new device against the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is an in vitro diagnostic (IVD) device for quantitative determination of IgE levels. The "ground truth" for the test set (the 188 samples) would be the IgE values obtained using the predicate device (Enzymun-Test® IgE) or a reference method. Therefore, human experts are not directly involved in establishing the ground truth in the same way they would be for image interpretation or clinical diagnosis. The "ground truth" is measured quantitatively by a validated assay.

4. Adjudication Method for the Test Set:

Not applicable as this is a quantitative IVD device. The "truth" is the measured IgE concentration, not a subjective interpretation requiring adjudication.

5. 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 device, not an AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes. This is a standalone automated immunoassay. The Elecsys® IgE Test operates without human intervention in the measurement process, once the sample is loaded and the test initiated. Its performance characteristics (precision, detection limit, range, specificity, method comparison) are all reported as "standalone" performance.

7. The Type of Ground Truth Used:

The ground truth for evaluating the Elecsys® IgE Test's performance (specifically for the method comparison) was generated by comparison to a legally marketed predicate device (Enzymun-Test® IgE). This is a common practice for demonstrating substantial equivalence for IVD devices. The predicate device itself would have been calibrated against a WHO Standard (as stated in the document), which serves as the ultimate reference for IgE quantification.

8. The Sample Size for the Training Set:

This document is a 510(k) summary for a traditional immunoassay, not an AI/ML device. Therefore, the concept of a "training set" for an algorithm is not applicable. The device's performance is driven by its reagent formulation, instrument design, and chemical reaction principles, not by a trained algorithm.

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