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Allergen ImmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic systems which measure specific IgE to the respective allergen bound to the ImmunoCAP™. Allergen ImmunoCAP™ are intended to be used with Pharmacia CAP System™ RAST FEIA and UniCAPTM Specific IgE in vitro diagnostic assays.

It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjynction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.

The Allergen ImmunoCAP™ consists of a cellulose sponge matrix to which allergenic components are covalently coupled. The matrix is encased in a small round plastic capsule. This capsule is at tha same time a holder of the matrix for convenient automation and a reaction chamber.

The sponge matrix is manufactured from activated cellulose derivative to which allergen extract solution is added under defined optimized conditions for the allergen coupling. This solid phase is an excellent carrier of allergens and provides favorable reaction conditions.

The Allergen ImmunoCAP™ m4 contains allergens from the mold Mucor racemosus, Allergen ImmunoCAP™ m8 from Helminthosporium halodes (both spores and mycelium). Identical sources and extracts are used for both the predicate device Phadebas RAST Paper Disc and ImmunoCAP™

The Allergen ImmunoCAP™ k70 contains allergens extracted from the Green Coffee Bean. Identical source and extract is also used for both the predicate device Phadebas RAST Paper Disc and ImmunoCAP™

Acceptance Criteria and Device Performance for Allergen ImmunoCAP™ m4, m8, k70

Study Details:

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

   • The document states that "Positive and negative sera from patients with and without specific IgE to each of the three allergens have been tested in all three test systems." However, the exact sample size (number of patients or serum specimens) used for the test set is not specified in the provided text.
   • The data provenance is retrospective, as existing "positive and negative sera" were used for the comparison studies. The country of origin of the data is not specified.

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

   • The document does not mention using experts to establish ground truth for the test set. Instead, the predicate device, Phadebas RAST® Allergen Paper Discs, served as the comparative standard.

3. Adjudication method for the test set:

   • No adjudication method is described. The comparison was made directly between the new device's results and the predicate device's results.

4. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • No MRMC comparative effectiveness study was mentioned or performed. This device is an in vitro diagnostic assay, not an imaging or diagnostic device typically requiring human reader interpretation.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • The study described is a standalone performance comparison of the new ImmunoCAP™ assays against the predicate Phadebas RAST® assays. There is no human-in-the-loop component for interpreting the results of these automated immunoassay systems.

6. Type of ground truth used:

   • The "ground truth" for the comparison study was the results obtained from the predicate device, Phadebas RAST® Allergen Paper Discs. This is a comparative study where the new device's performance is measured against an established, legally marketed device.

7. Sample size for the training set:

   • The document does not specify a separate "training set" or its sample size. This type of immunoassay development typically involves optimization and validation rather than machine learning training sets in the conventional sense. The "comparison studies" effectively serve as validation.

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

   • As no specific training set is mentioned in the machine learning context, the method for establishing its ground truth is not applicable here. The overall "ground truth" for the device's accuracy is based on its correlation with the predicate device.

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