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The IMMULITE® 2000 3gAllergy™ Specific IgE Universal Kit is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer — for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

IMMULITE® 2000 3gAllergy™ Specific IgE Universal Kit assay is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support. The allergens are covalently bound to a soluble polymer/co-polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support. This 510(k) submission is for clearance of seven additional specific molecular allergens shown in Table 1 to be used with the IMMULITE® 2000 3gAllergy™ Specific IgE Universal Kit on the IMMULITE® 2000 analyzer.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary (K132801):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance test results provided and the statement that the device "meets the criteria for acceptable repeatability, within-lab, and lot-to-lot precision." The summary also states that the device's working range is 0.10 to 100 kU/L, and its detection limits are ≤0.10 kU/L.

The acceptance criteria for precision (repeatability, within-lab, and lot-to-lot) were met for all allergens after addressing outliers as indicated by "No outliers used in calculation" footnotes for some positive samples.

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

• Non-Clinical Performance (Precision):
  • For each allergen lot and positive sample: 84 (2 runs/day x 20 days x 3 replicates, with some adjustments for outliers resulting in 80 or 79 valid data points).
  • For lot-to-lot precision: 332-334 samples (across 4 lots of each allergen).
  • For negative control: 84 samples (across multiple runs/days).
• Non-Clinical Performance (Detection Limits - LoB): 80 data points for each allergen lot (4 blank samples tested in replicates of two, with one run per day, over five days, using two instruments and three lots of allergen).
• Non-Clinical Performance (Detection Limits - LoD): At least 60 data points for each allergen lot (4 low positive samples tested in replicates of two, with one run per day, over five days, using two instruments and three lots of allergen).
• Clinical Performance:
  • Total Samples: 1,146 human serum samples (162 positive by IMMULITE®, 984 negative by IMMULITE®; 327 clinically positive, 819 clinically normal).
  • Data Provenance: The document does not specify the country of origin of the data. The data is retrospective, as it involves testing serum samples that were associated with "clinical documentation of presence of signs, symptoms and other diagnostic evidence of allergen sensitivity" or "clinically diagnosed atopic and non-atopic individuals."

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience as a radiologist). However, the clinical ground truth for the clinical performance study was based on "clinical documentation of presence of signs, symptoms and other diagnostic evidence of allergen sensitivity." This implies that the diagnosis was established by medical professionals in a clinical setting.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the clinical diagnosis of the test set. It refers to "clinical documentation of presence of signs, symptoms and other diagnostic evidence of allergen sensitivity," suggesting standard clinical diagnostic practices were followed.

5. 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 designed for quantitative measurement of IgE. The performance validation focuses on analytical precision, detection limits, specificity, linearity and clinical agreement with existing clinical diagnoses, not on the improvement of human reader performance with or without AI assistance.

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

Yes, the studies described are standalone performance studies for the device (IMMULITE® 2000 3gAllergy™ Specific IgE Universal Kit) as an automated in vitro diagnostic test. The precision, detection limits, specificity, and linearity tests evaluate the algorithm/assay performance directly. The "clinical performance testing" evaluates the device's quantitative measurements against an established clinical diagnosis, which is a standalone assessment of the device's diagnostic utility. There is no human-in-the-loop component in the direct measurement process of this diagnostic kit.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Non-Clinical Tests: The ground truth for precision, detection limits, and linearity is based on known concentrations of analytes in controlled samples (e.g., positive samples, blank samples, diluted samples, calibrators).
• Specificity Tests: The ground truth for specificity (inhibition and cross-reactivity) is based on the known presence or absence of specific inhibitor extracts or irrelevant/related allergens.
• Clinical Performance: The ground truth for clinical performance was "clinical documentation of presence of signs, symptoms and other diagnostic evidence of allergen sensitivity" for "clinically diagnosed atopic and non-atopic individuals." This is a form of outcomes data or clinical diagnosis that relies on a combination of clinical findings and potentially other laboratory tests as determined by medical professionals.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. This is common for IVD devices of this type, where method validation studies (like precision, linearity, detection limits) establish robust analytical performance using controlled samples, and then a separate clinical performance study assesses agreement with clinical diagnoses. The document focuses on performance testing rather than machine learning model training.

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

As no specific "training set" for a machine learning model is mentioned, the method for establishing its ground truth is not applicable to this submission. The validation studies for this IVD device use reference materials and clinical diagnoses as their basis for ground truth.

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