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The ADVIA Centaur® TSH3-Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

This assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection.

The provided text describes the ADVIA Centaur® TSH3-Ultra II (TSH3ULII) assay, a device for in vitro diagnostic quantitative determination of thyroid-stimulating hormone (TSH). The document covers the device's indications for use, comparison with a predicate device, and performance characteristics data.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Limit of Detection (LoD): 0.008 µIU/mL (mIU/L)
• Limit of Quantitation (LoQ): 0.010 µIU/mL (mIU/L) (Lower than predicate device's LoQ of 0.008 µIU/mL, but within acceptable range for the new device as specified in assay range) |
  | Precision | - Repeatability (Within-Run):
  • ≤ 12% CV for 0.020–0.299 µIU/mL (mIU/L)
  • ≤ 6% CV for ≥ 0.300–90.000 µIU/mL (mIU/L)
  • ≤ 7% CV for > 90.000 µIU/mL (mIU/L)
• Within-Laboratory (Total Precision):
  • ≤ 16% CV for 0.020–0.299 µIU/mL (mIU/L)
  • ≤ 8% CV for ≥ 0.300–90.000 µIU/mL (mIU/L)
  • ≤ 10% CV for > 90.000 µIU/mL (mIU/L) | Reported values (all calculated Repeatability CV and Within-Laboratory CV values are within the specified limits):
• Serum A (0.088 µIU/mL): Repeatability CV 2.5%, Within-Lab CV 3.6%
• Serum B (0.196 µIU/mL): Repeatability CV 1.8%, Within-Lab CV 3.1%
• Serum C (0.507 µIU/mL): Repeatability CV 1.7%, Within-Lab CV 2.6%
• Serum D (4.752 µIU/mL): Repeatability CV 2.3%, Within-Lab CV 2.7%
• Serum E (46.749 µIU/mL): Repeatability CV 2.4%, Within-Lab CV 4.0%
• Serum F (97.929 µIU/mL): Repeatability CV 2.2%, Within-Lab CV 3.5%
  Similar acceptable results for Plasma and Controls. |
  | Reproducibility | - Reproducibility (Total):
  • ≤ 18.5% CV for 0.020-0.299 µIU/mL (mIU/L)
  • ≤ 10.5% CV for ≥ 0.300-90.000 µIU/mL (mIU/L)
  • ≤ 12.5% CV for > 90.000 µIU/mL (mIU/L) | Reported values (all calculated Reproducibility CV values are within the specified limits):
• Serum A (0.090 µIU/mL): Reproducibility CV 3.11%
• Serum B (0.178 µIU/mL): Reproducibility CV 4.87%
• Serum C (0.474 µIU/mL): Reproducibility CV 2.21%
• Serum D (4.684 µIU/mL): Reproducibility CV 2.47%
• Serum E (56.562 µIU/mL): Reproducibility CV 2.33%
• Serum F (99.522 µIU/mL): Reproducibility CV 4.12%
  Similar acceptable results for Plasma and Controls. |
  | Assay Comparison | - Correlation coefficient (r) ≥ 0.95
• Slope of 1.0 ± 0.1 | - Correlation coefficient (r): 0.999
• Regression Equation (Slope): 0.97 (within 1.0 ± 0.1) |
  | Specimen Equivalency | - Correlation coefficient (r) ≥ 0.95
• Slope of 0.95-1.05 | - Plasma, EDTA vs. Serum: r = 0.999, Slope = 0.99 (within 0.95-1.05)
• Plasma, lithium heparin vs. Serum: r = 0.990, Slope = 1.01 (within 0.95-1.05) |
  | Interferences (HIL) | Bias due to hemoglobin, bilirubin (conjugated/unconjugated), and Intralipid does not exceed 10% | Hemoglobin (500mg/dL), Bilirubin (40mg/dL), Intralipid (1000mg/dL) do not exceed 10% bias at TSH concentrations of ~0.900 µIU/mL and ~8.000 µIU/mL. |
  | Interferences (Other Substances) | Bias due to various common substances does not exceed 10% | Various substances (e.g., Acetaminophen, Aspirin, Biotin, Heparin, Ibuprofen, Levothyroxine) at specified concentrations do not exceed 10% bias at TSH concentrations of ~0.900 µIU/mL and ~8.000 µIU/mL. |
  | Cross-Reactivity | Cross-reactivity of hCG, FSH, and LH does not exceed 5% | hCG (200000 mIU/mL), FSH (1500 mIU/mL), LH (600 mIU/mL) at specified concentrations do not exceed 5% cross-reactivity at TSH concentrations of ~0.400, 5.00, 17.00, and 90.00 µIU/mL. |
  | Linearity | Device is linear throughout its measuring interval (0.010–150.000 µIU/mL) | "The assay is linear for the measuring interval of 0.010–150.000 µIU/mL (mIU/L)." |
  | High-Dose Hook Effect | Results for TSH concentrations above the measuring interval and up to 3000 µIU/mL should report > 150 µIU/mL (not a paradoxical decrease) | "Patient samples with TSH concentrations above the measuring interval and as high as 3000 µIU/mL will report > 150 µIU/mL (mIU/L)." (This confirms the absence of a significant high-dose hook effect within this specified range, meaning the device displays the result as above the measurable range.) |

The study that proves the device meets the acceptance criteria is detailed across the "Performance Characteristics Data" section (Section 8) of the 510(k) Summary.

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

• Detection Capability (LoQ): Not specified (CLSI Document EP17-A2 was followed).
• Precision: 80 measurements (replicates of 2, 2 runs/day, 20-day protocol) for each of the 6 serum samples, 5 plasma samples, and 5 control samples. Total N for Precision study is 80 x (6+5+5) = 1280 measurements.
• Reproducibility: 225 measurements (replicates of 5, 1 run/day, 5-day protocol) for each of the 6 serum samples, 5 plasma samples, and 5 control samples. Total N for Reproducibility study is 225 x (6+5+5) = 3600 measurements.
• Assay Comparison: 973 samples.
• Specimen Equivalency:
  • Plasma, EDTA vs. Serum: 52 samples.
  • Plasma, lithium heparin vs. Serum: 57 samples.
• Interferences (HIL and Other Substances): Samples at two TSH concentrations (~0.900 µIU/mL and ~8.000 µIU/mL) were tested for each interfering substance. The exact number of individual samples tested is not given, but multiple samples would be required for the two TSH levels per substance.
• Cross-Reactivity: Samples at four TSH concentrations (~0.400, 5.00, 17.00, and 90.00 µIU/mL) were spiked with hCG, FSH, or LH. The exact number of individual samples is not given.
• Linearity: Not explicitly stated, but performed in accordance with CLSI Document EP06-ed2, which involves testing multiple diluted samples.
• High-Dose Hook Effect: Samples with TSH concentrations up to 3000 µIU/mL were evaluated. The number of samples tested is not explicitly stated.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's an in vitro diagnostic device, the samples would generally be human biological specimens, likely collected from a clinical laboratory setting. The use of CLSI documents (Clinical and Laboratory Standards Institute) suggests standard laboratory practices.

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

This information is not provided in the document. For an in vitro diagnostic assay like TSH, "ground truth" is typically established by:

• The reference method against which the new assay is compared (for accuracy/assay comparison). In this case, "ADVIA Centaur TSH3-UL assay" is used as the comparative assay (the predicate device).
• Traceability to an international standard (WHO 3rd International Reference Preparation for human TSH (IRP 81/565)), which implies that the TSH values are calibrated against a universally accepted standard, rather than expert consensus on individual patient cases.

4. Adjudication Method for the Test Set

This refers to the process of resolving discrepancies in expert opinions, which is not applicable here as it is an analytical performance study for an IVD, not an interpretative AI device requiring human expert label agreement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This document pertains to an in vitro diagnostic assay, which involves automated quantitative measurement of a biomarker.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The entire performance characterization (Detection Capability, Precision, Reproducibility, Assay Comparison, Specimen Equivalency, Interferences, Cross-Reactivity, Linearity, High-Dose Hook Effect) is describing the standalone performance of the TSH3-Ultra II assay as an automated laboratory test. There is no mention of "human-in-the-loop" for this device's intended diagnostic function.

7. Type of Ground Truth Used

The ground truth for the performance studies is established by:

• Reference materials/standards: For accuracy, the assay is traceable to the World Health Organization (WHO) 3rd International Reference Preparation for human TSH (IRP 81/565).
• Comparative method: For assay comparison, the predicate device (ADVIA Centaur TSH3-UL assay) results serve as the comparative standard.
• Defined concentrations: For precision, linearity, interferences, and cross-reactivity, samples with known or spiked concentrations of TSH or interfering substances are used.

8. Sample Size for the Training Set

The document does not report a training set sample size. This is because the ADVIA Centaur TSH3-Ultra II is a chemical immunoassay, not a machine learning or AI-based device that would typically involve a "training set" in the computational sense. The "development" process for such an assay involves reagent formulation, assay optimization, and calibration curve development, which are distinct from training an AI model.

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

As there is no "training set" in the context of an AI/ML model, this question is not applicable. The assay's analytical characteristics are established through various studies (precision, accuracy, linearity, etc.) using calibrated materials and established reference methods, as detailed in the performance characteristics.

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The Trinidad Immunoassay (IM) system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The Trinidad IM system's assay applications utilize chemiluminescent technology for clinical use.

The Trinidad IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Trinidad IM system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Trinidad IM TSH Calibrators are for in vitro diagnostic use in calibrating the Trinidad IM system TSH assay.

The Siemens Healthcare Diagnostics Trinidad Immunoassay (IM) system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software.

The Trinidad IM TSH assay reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following:
500 Test Kit:

• 5 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, Solid Phase, and Ancillary Reagent
• 2 vials of lyophilized Trinidad IM TSH low calibrator
• 2 vials of lyophilized Trinidad IM TSH high calibrator

100 Test Kit:

• 1 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, Solid Phase, and Ancillary Reagent
• 1 vial of lyophilized Trinidad IM TSH low calibrator
• 1 vial of lyophilized Trinidad IM TSH high calibrator

The ReadyPack consists of the following:

• Lite Reagent 6.0 mL/ reagent pack: The Lite Reagent contains bovine serum albumin (BSA) conjugated to murine monoclonal anti-TSH (~0.3 µg/mL) antibody labeled with acridinium ester, buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.
• Solid Phase Reagent 21.0 mL/ reagent pack: The Solid Phase reagent contains anti-fluorescein murine monoclonal antibody covalently linked to paramagnetic particles (~85 µg/mL), buffer, stabilizers (bovine, caprine proteins), surfactant, and preservatives.
• Ancillary Reagent 6.0 mL/ reagent pack: The Ancillary reagent contains FITC conjugated to murine monoclonal anti-TSH antibody (~3 µg/mL), buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.

The TSH Calibrator consists of the following:

• After reconstitution, low and high levels of thyroid stimulating hormone (TSH) in HEPES buffered equine serum with sodium azide (

Here's a breakdown of the acceptance criteria and the study details for the Trinidad IM Thyroid Stimulating Hormone (TSH) assay, Trinidad Immunoassay (IM) system, and Trinidad IM TSH Calibrators, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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