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510(k) Data Aggregation
(145 days)
PHARMACIA CAP SYSTEM RAST FEIA
Pharmacia CAP System RASTR FEIA is an in vitro test Intended Use: which measures the concentration of circulating allergen specific IgE in human blood samples. For in vitro Diagnostic Use Only. The Specific Allergen in this submission is k82. Latex. which is an additional allergen being added to the Pharmacia CAP System RAST FEIA.
Pharmacia CAP System RAST FEIA is an in vitro test system, based on ImmunoCAP technology for determination of circulating specific IgE antibodies. The allergen of interest (Latex), covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient serum specimen. After washing away non-specific IgE. enzyme labeled antibodies against IgE are added to form a complex. Anti-IgE raised in rabbits and labeled with Beta-galactosidase is the enzyme system used. After incubation, unbound enzyme anti-IgE is washed away and the bound complex is then incubated with the developing agent, 4methylumbelliferyl-ß-D-galactoside. After stopping the reaction with 4% sodium carbonate, the fluorescence of the eluate is measured in the Fluorcount 96 according to the User Manual for the instrument. The higher the fluorescence value, the greater the quantity of specific IgE present in the specimen. To classify test results, fluorescence (FU) of patient samples are compared directly with FU for the standards run in parallel.
Here's an analysis of the provided text regarding the Pharmacia CAP System RAST FEIA (Allergen ImmunoCAP k82, Latex) device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds within the provided text. However, the study focuses on demonstrating "excellent clinical performance" and "equivalence to the predicate device." Based on this, we can infer that the reported percentages represent the device meeting these implicit criteria.
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Clinical Sensitivity | Excellent clinical performance (e.g., above 60-70%) | 74.8% (95% CI: 63.5 - 83.2%) |
| Clinical Specificity | Excellent clinical performance (e.g., above 90%) | 93.8% (95% CI: 86.4 - 97.7%) |
| Total Agreement with Clinical Diagnosis/Skin Test | Excellent clinical performance (e.g., above 80%) | 83.6% (95% CI: 77.1 - 88.6%) |
| Relative Sensitivity (vs. Predicate Device) | Equivalent to predicate device (e.g., above 80-90%) | 91.6% (95% CI: 82.6 - 96.6%) |
| Relative Specificity (vs. Predicate Device) | Equivalent to predicate device (e.g., above 80-90%) | 89.5% (95% CI: 82.1 - 94.4%) |
| Overall Agreement (vs. Predicate Device) | Equivalent to predicate device (e.g., above 85-90%) | 90.3% (95% CI: 85.1 - 94.1%) |
| Intraassay (within-run) variation | Within 7-10% (as per Directions for Use) | 3.7 - 4.6% |
| Interassay (between-run within day) variation | Within 6-9% (as per Directions for Use) | 5.6 - 6.1% |
| Lot-to-lot variation | Not explicitly stated as a separate acceptance criterion, but low variation is desirable. | 5.0 - 7.6% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 207 patients
- Data Provenance: Serum samples from patients at "three clinical sites." The country of origin is not explicitly stated, but the company contact details (Kalamazoo, Mi 49001) suggest a US-based study or at least the sponsor is US-based. The data is retrospective as it consists of existing "serum samples from a total of 207 patients".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text states that 111 patients were "diagnosed as clinically allergic to latex and had a positive latex skin test," and 96 patients were "clinically negative and had negative latex skin test." The ground truth was established by "clinical diagnosis and latex skin test."
- Number of Experts: Not specified. It's implied that various clinicians and/or allergists were involved in the clinical diagnoses and performing skin tests at the "three clinical sites."
- Qualifications of Experts: Not explicitly stated, but it's presumed these were medical professionals equipped to make clinical diagnoses of allergies and perform skin tests.
4. Adjudication Method for the Test Set
The adjudication method is implicitly through the "clinical diagnosis and latex skin test results." This suggests a consensus or established clinical practice for defining latex allergy status. There is no explicit mention of a formal adjudication process (e.g., 2+1, 3+1) among multiple independent reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's performance against clinical diagnosis and a predicate device, not against human readers' performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study represents a standalone performance evaluation. The Pharmacia CAP System RAST FEIA is an in vitro diagnostic test that measures a biomarker (circulating allergen specific IgE). Its performance (sensitivity, specificity, agreement) is assessed directly against the clinical ground truth and a predicate device, without a human-in-the-loop component.
7. The Type of Ground Truth Used
The ground truth used was a combination of:
- Expert Consensus/Clinical Diagnosis: "Clinically allergic to latex" or "clinically negative."
- Concordant Objective Test: "Positive latex skin test" or "negative latex skin test."
This represents a strong clinical ground truth, combining expert assessment with a well-established in vivo diagnostic test.
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. This is typical for submissions for predicate devices where the method and assay principles are established, and the focus is on demonstrating performance for a new specific allergen. The primary study described is a clinical validation study.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, information on how its ground truth was established is not provided.
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