(72 days)
For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum, heparinized plasma, and EDTA plasma using the ADVIA Centaur XP systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
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The provided text describes an update to a previously approved device, the ADVIA Centaur® TSH3-Ultra assay, to include updated pediatric reference intervals. Crucially, the 510(k) submission (K150403) explicitly states that no additional analytical performance data was collected for this update. Instead, it cross-references all performance data to the original 510(k) submission (K083844) for the device.
Therefore, the acceptance criteria and the study that "proves the device meets the acceptance criteria" in this context primarily pertain to the establishment of the pediatric reference intervals, and not to the broader analytical performance of the device (such as precision, linearity, sensitivity, etc.), which was evaluated in the original submission.
Here's the breakdown based on the information provided for the pediatric reference interval update:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for the device performance itself (e.g., accuracy, precision) is not explicitly detailed in this document for the current submission (K150403), as that data was accepted in the original 510(k). The focus of this submission is on the establishment of new reference intervals. For the purpose of these new intervals, the acceptance criteria would be that the established intervals are representative of the studied pediatric population and align with recognized medical practice for TSH interpretation in these age groups.
| Acceptance Criteria (for Pediatric Reference Intervals) | Reported Device Performance (Reference Intervals) |
|---|---|
| Appropriately established reference intervals for different pediatric age groups. | Infants (01-23M): 0.87 – 6.15 μIU/mL (mIU/L) |
| Children (02-12Y): 0.67 – 4.16 μIU/mL (mIU/L) | |
| Adolescents (13-21Y): 0.48 – 4.17 μIU/mL (mIU/L) | |
| Infant reference intervals within or above established adult/pediatric intervals and within assay measuring range. | Satisfied. The newly-established infant reference intervals are either within or are above the previously-established reference intervals for euthyroid (normal thyroid) adult and pediatric populations and they are within the analytical measuring ranges of the ADVIA Centaur TSH3-Ultra assay. (Assay Range: 0.008 – 150 μIU/mL) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 442 patients were analyzed.
- 94 infants
- 198 children
- 150 adolescents
- Data Provenance: Not explicitly stated (e.g., country of origin, specific sites). The document is a 510(k) submission to the FDA for a device manufactured by Siemens Healthcare Diagnostics, Inc. (Tarrytown, NY), but this does not specify the origin of the clinical samples.
- Retrospective or Prospective: Not explicitly stated. The phrasing "Data from a total of 442 patients... were analyzed to establish..." suggests this could be retrospective analysis of existing samples or prospectively collected samples for this study. The document focuses on the analysis of these patients' data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not mentioned in this document. The establishment of reference intervals typically involves statistical analysis of a healthy population, with clinical review of the resulting intervals by medical professionals. However, specific details on expert involvement for this particular data are absent.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. The study involved establishing reference intervals, which is a statistical process based on a healthy population, rather than assessing diagnostic accuracy against "ground truth" labels that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay (a laboratory test), not an imaging or diagnostic device that typically involves human readers interpreting results. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.
6. Standalone Performance Study (Algorithm Only)
- Yes, in a sense, a standalone study was presented for the establishment of the reference intervals. The output (the reference interval values) is directly derived from the measurements from the device (ADVIA Centaur TSH3-Ultra) on the patient samples. The device itself performs the quantitative determination of TSH. The performance characteristics of the assay (precision, linearity, etc.) were established in the original 510(k) (K083844) as a standalone algorithm/device. This current submission focuses on applying that standalone performance to interpret results within newly defined pediatric reference ranges.
7. Type of Ground Truth Used (for pediatric reference intervals)
- The "ground truth" for establishing reference intervals is typically based on measurements from a statistically representative population of healthy individuals (euthyroid individuals in this case). The objective is to define the range of normal values within specific demographics (age groups) for a given analyte. The document specifies that these are for "ADVIA Centaur thyroid assay reference intervals for the studied pediatric population," implying these individuals were considered clinically "normal" or "euthyroid" for TSH levels.
8. Sample Size for the Training Set
- The 442 patients (94 infants, 198 children, 150 adolescents) mentioned for establishing the pediatric reference intervals essentially serve as the "training set" (or more accurately, the reference population set) for these intervals. There's no separate mention of a distinct training set vs. test set for the reference interval establishment itself, as the goal is to define the range from this population.
- For the analytical performance of the assay (linearity, precision, etc.), the training sets would have been part of the original K083844 submission and are not detailed here.
9. How the Ground Truth for the Training Set (Reference Population) Was Established
- The ground truth for the pediatric reference population (i.e., defining "healthy" or "euthyroid") is implied to be through clinical assessment and exclusion criteria, although not explicitly detailed. Reference interval studies typically involve recruiting subjects who are free from conditions that might affect the analyte being measured. The standard followed, CLSI EP28-A3c ("Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory"), describes methods for selecting and characterizing a reference population to establish clinical reference intervals.
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.