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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 UniCAP™ Specific IgE in vitro diagnostic assays.

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 the 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Allergen ImmunoCAP™ device:

It is important to note that the provided text is a summary of a 510(k) submission from 1997, focusing on establishing substantial equivalence for new allergens to existing systems. This type of submission often relies on demonstrating that the new components function similarly to previously cleared ones, rather than conducting extensive new clinical trials with detailed acceptance criteria and standalone performance studies as might be expected for novel devices in today's regulatory landscape.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in numerical thresholds (e.g., sensitivity, specificity percentages). Instead, it focuses on demonstrating "complete agreement of outcome concerning positive and negative samples" between the new Allergen ImmunoCAP™ and the predicate devices (Pharmacia CAP System™ RAST FEIA and UniCAP™ Specific IgE).

Study Details

Detailed information regarding the specific study or studies conducted for this particular 510(k) submission is limited. The document references established safety and effectiveness for the test systems (Pharmacia CAP System™ RAST FEIA and UniCAP™ Specific IgE) from previous submissions (K894190, K911903, K962274), and focuses on showing that the new allergens (Walnut, Whole Egg, Clam, Cashew Nut) integrate seamlessly and perform equivalently within those established systems.

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

   • Sample Size: Not explicitly stated. The document mentions "testing clinical serum samples, with a history or indication of allergy to the specific allergen, and established negative samples." No specific numbers for positive or negative samples are provided.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinical serum samples." It is likely retrospective, as it refers to samples "with a history or indication of allergy" and "established negative samples."

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

   • Not specified. The ground truth appears to be derived from the patient's "history or indication of allergy" and "established negative samples" rather than concurrent expert consensus on the test samples themselves.

3. Adjudication method for the test set:

   • Not applicable/specified. The mechanism for determining "established negative samples" or "history or indication of allergy" is not described as a formal adjudication process.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay; its performance is measured instrumentally rather than through human reader interpretation of images or other subjective data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

   • Yes, implicitly. The performance characteristics described are related to the analytical performance of the ImmunoCAP™ components within the larger test systems (Pharmacia CAP System™ RAST FEIA and UniCAP™ Specific IgE). These are automated or semi-automated assays where the "algorithm" is the biochemical reaction and detection system. The "performance characteristics" section describes testing these systems directly, without human interpretation of the final result other than reading the quantitative output and comparing it to cut-offs.

6. The type of ground truth used:

   • The ground truth appears to be a combination of:
     • Clinical history/indication: "clinical serum samples, with a history or indication of allergy to the specific allergen."
     • Established negative status: "established negative samples."
   • This is not explicitly "pathology" or "outcomes data" in the typical sense but rather clinical characterization of the patient's allergic status.

7. The sample size for the training set:

   • Not applicable/stated. This document describes the performance of specific ImmunoCAP™ additions to existing test systems. The ImmunoCAP™ itself is a biochemical component, not a machine learning algorithm that requires a "training set" in the computational sense. The "training" in this context would refer to the optimization of the coupling process for the allergen as mentioned in the "General Description."

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

   • Not applicable. As noted above, there isn't a "training set" in the AI/ML sense. The optimization of the allergen coupling to the ImmunoCAP™ would be established through biochemical and analytical validation steps, not a "ground truth" derived from patient data.

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