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The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 3gAllergy Specific IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.
The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration of the IMMULITE 2000 Total IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.

The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is supplied frozen in liquid form. It consists of one set of four vials, 2 mL each. L2UNCVM1 contains equine serum matrix with 0.098% sodium azide and preservatives. L2UNCVM2, L2UNCVM3 and L2UNCVM4 contain various levels of human IgE positive serum in an equine serum matrix with 0.098% sodium azide and preservatives.
The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is supplied frozen in liquid form. It consists of one set of four vials, 3 mL each. LIECVM1 contains equine serum matrix with 0.098% sodium azide and preservatives. LIECVM2, LIECVM3 and LIECVM4 contain various levels of human IgE positive serum in an equine serum matrix with 0.098% sodium azide and preservatives.

This document describes the IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) and the IMMULITE 2000 Total IgE Calibration Verification Material (CVM). Both are intended for in vitro diagnostic use as controls for calibration verification of their respective IMMULITE 2000 assays.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

There are two separate products described in this 510(k) submission: the IMMULITE 2000 3gAllergy Specific IgE CVM and the IMMULITE 2000 Total IgE CVM. Both have similar acceptance criteria for stability.

IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM)

IMMULITE 2000 Total IgE Calibration Verification Material (CVM)

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

The "test set" for performance evaluation appears to be the samples used in the stability studies and value assignment processes.

• For both CVMs (3gAllergy Specific IgE and Total IgE):
  • Sample Size: The calibrators/CVMs were tested on 27 replicates in total, comprised of 9 runs, 8 systems, and (for 3gAllergy Specific IgE) 3 different reagent kit lots, and (for Total IgE) 5 different reagent kit lots. The stability protocols state CVMs are run in duplicate (as a minimum) at specified time points (e.g., 1, 182, 365, 548, 730 days).
  • Data Provenance: Not explicitly stated as "country of origin" but implies retrospective testing of manufactured CVMs over time to assess stability. The manufacturing location of Siemens Healthcare Diagnostics Inc. is Tarrytown, NY, USA, which usually indicates the data is generated within the US or a facility overseen by the US entity.

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

• Not Applicable. This submission is for Calibration Verification Materials, not for a diagnostic device that requires expert interpretation of results. The "ground truth" for these materials is established through analytical methods and traceability to international standards (WHO 2nd IRP (75/502)).

4. Adjudication Method for the Test Set

• Not Applicable. As this is an analytical device for calibration verification, there's no "adjudication" in the sense of resolving discrepancies between human interpretations or diagnostic outcomes. The performance is assessed against predefined analytical acceptance criteria. The "Part 2 review limits criteria" (dose value of controls within 2SD of the control target value) act as an internal review mechanism, but it's not and adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is a quality control material and not a diagnostic device involving human readers or interpretation of complex cases. Therefore, an MRMC comparative effectiveness study is not applicable.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

• Yes, in essence. The performance studies conducted (stability, value assignment) evaluate the analytical performance of the CVMs themselves in conjunction with the IMMULITE 2000 system, without human interpretation of results influencing the CVM's "performance" at a diagnostic level. The CVM is an "algorithm only" device in a metaphorical sense, as its function is to provide expected values for system calibration verification.

7. The Type of Ground Truth Used

• Traceability to International Reference Standards: The "ground truth" for the assigned values of the CVMs is their traceability to the WHO 2nd IRP (75/502). This is an international reference preparation for IgE, providing a recognized standard for quantifying IgE concentrations. The assigned reference calibrators are also prepared using specific antigen stocks (Scipac for 3gAllergy Specific IgE, Bioresource for Total IgE) which are traceable to this WHO standard.

8. The Sample Size for the Training Set

• Not Applicable/Not Explicitly Defined as "Training Set": For a calibration verification material, there isn't a "training set" in the typical machine learning sense. However, the value assignment process for the CVMs involves extensive testing to establish the target mean and guideline ranges. This process is akin to establishing reference data.
  • For both CVMs: The calibrators/CVMs were tested on 27 replicates in total comprised of 9 runs, 8 systems, and 3 or 5 different reagent kit lots. This rigorous testing helps "train" or establish the expected performance parameters for the CVMs.

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

• Traceability and Extensive Analytical Testing: The "ground truth" (assigned values, target means, and guideline ranges) for the value assignment process was established using:
  • Assigned Reference Calibrators: These are prepared using specific IgE antigen stock traceable to the WHO 2nd IRP (75/502).
  • Qualified Materials and Measurement Procedures: The CVMs are manufactured and tested using these throughout.
  • Statistical Analysis of Multiple Replicates: Dose values were determined from reference calibrator curves, and calibrator/CVM values were calculated based on recovered values for each run on each instrument independently, then averaged across all systems. Quality control ensures assay controls fall within target ranges. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2SD from this extensive testing.

In summary, the studies conducted focus on the analytical performance, specifically the stability and accurate value assignment of these calibration verification materials, rather than clinical diagnostic accuracy or reader performance studies.

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