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510(k) Data Aggregation
(85 days)
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of thyrotropin (TSH) in serum. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of non-protein-bound thyroxine (free T4) in serum and heparinized plasma. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease.
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The provided text describes a 510(k) submission for the IMMULITE 2000 Third Generation TSH and IMMULITE 2000 Free T4 assays. The submission primarily focuses on adding pediatric reference intervals to the device's labeling and asserts that no modifications to the device's design or manufacturing processes are required, thus the predicate devices and subject devices are the same. This means that no new device performance studies were conducted for this specific submission, as the changes are limited to labeling updates based on existing assay capabilities and establishing new reference intervals for a specific population.
Therefore, the requested information regarding acceptance criteria and device performance for a new device study is largely not applicable in the context of this 510(k) summary, as it explicitly states that additional analytical performance data is not needed. The document emphasizes that existing performance characteristics continue to apply.
However, I can extract information related to the establishment of the pediatric reference intervals, which is a form of study performed to define normative values for a specific population for the device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission is about establishing new reference intervals for an already approved device and not evaluating the device's analytical performance against new acceptance criteria, the "acceptance criteria" here refer to the statistical methodology used for defining these reference intervals. The "reported device performance" is the established reference interval.
| Parameter | Acceptance Criteria (Methodology for Reference Interval Establishment, per CLSI EP28-A3c) | Reported Device Performance (Established Pediatric Reference Intervals) |
|---|---|---|
| IMMULITE 2000 Free T4 | ||
| Infants (01 – 23 months) | Robust Symmetric (90% CI for Lower/Upper Limit) | 0.80 – 1.27 ng/dL (10.3 – 16.3 pmol/L) |
| Children (02 – 12 years) | Non-Parametric | 0.74 – 1.28 ng/dL (9.5 – 16.5 pmol/L) |
| Adolescents (13 – 20 years) | Non-Parametric | 0.75 – 1.27 ng/dL (9.7 – 16.3 pmol/L) |
| IMMULITE 2000 Third Gen TSH | ||
| Infants (01 – 23 months) | Robust Symmetric after Log Transform (90% CI for Lower/Upper Limit) | 0.83 – 6.5 µIU/mL (mIU/L) |
| Children (02 – 12 years) | Non-Parametric | 0.58 – 4.1 µIU/mL (mIU/L) |
| Adolescents (13 – 20 years) | Non-Parametric | 0.39 – 4.0 µIU/mL (mIU/L) |
Note: The primary "acceptance criteria" for this submission are that the methods used for establishing the reference intervals conform to CLSI EP28-A3c guidance and that the established pediatric reference intervals fall within the existing analytical measuring capability of the assay.
2. Sample size used for the test set and the data provenance
IMMULITE 2000 Free T4:
- Sample Size: A total of 426 patients were analyzed:
- Infants (01 – 23 months): 81
- Children (02 – 12 years): 197
- Adolescents (13 – 20 years): 148
- Data Provenance: The document does not specify the country of origin of the data. It is prospective testing, as it states "Data from a total of [N] patients... tested with the IMMULITE 2000 Free T4 assay were analyzed to establish the reference intervals."
IMMULITE 2000 Third Generation TSH:
- Sample Size: A total of 433 patients were analyzed:
- Infants (01 – 23 months): 90
- Children (02 – 12 years): 195
- Adolescents (13 – 20 years): 148
- Data Provenance: The document does not specify the country of origin of the data. Similar to Free T4, this appears to be prospective testing based on the phrasing "Data from a total of [N] patients... tested with the IMMULITE 2000 Third Generation TSH assay were analyzed to establish the reference intervals."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For reference interval studies, the "ground truth" is typically defined by statistical methods applied to a population defined as "healthy" or "normal" for the analyte in question, rather than through expert consensus on individual cases. The document states that the reference intervals were established per the CLSI EP28-A3c guideline: "Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory." This guideline outlines statistical procedures for determining reference intervals. Therefore, independent experts for case-by-case ground truth establishment are not typically involved in this type of study. The expertise lies in the clinical chemists or statisticians who apply the CLSI guideline.
4. Adjudication method for the test set
Not applicable. Reference interval studies do not typically involve adjudication of individual cases in the way diagnostic accuracy studies do. The process involves identifying a healthy reference population and then statistically determining the range of values for that population.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for an in-vitro diagnostic (IVD) assay (a lab test), not an AI-based diagnostic imaging or interpretive device that would involve human readers or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an IVD assay, which generates quantitative results. The device itself is the "standalone" component in the sense that it performs the measurement. The establishment of reference intervals is for interpreting these quantitative results within a specific population.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the pediatric reference interval studies relies on the selection of a "healthy" pediatric population (presumably free from known thyroid or pituitary disorders) from whom samples were collected and tested. The reference intervals are then statistically derived from the measurements of these healthy individuals, following CLSI EP28-A3c guidelines. This is a statistical definition of "normal range" within a defined population rather than a case-specific ground truth like pathology or expert consensus for individual diagnoses. The assumption is that the participants in these groups represented a healthy pediatric population for thyroid function.
8. The sample size for the training set
Not applicable in the typical sense of machine learning. The data described (426 for Free T4, 433 for TSH) is used to establish the reference intervals (similar to a development/validation set in traditional statistics), rather than "training" an algorithm that would then be separately tested. The entire dataset is used to directly calculate the intervals.
9. How the ground truth for the training set was established
Not applicable as a "training set." The "ground truth" for the reference interval establishment relies on the statistical methodology (Robust Symmetric, Non-Parametric) applied to a population described as healthy, as per CLSI EP28-A3c. The selection criteria for this "healthy" pediatric population are implied to be part of the study design to appropriately define the "normal" range.
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