(135 days)
The FastPack® TSH Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of Thyroid-Stimulating Hormone in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH is designed for use with the FastPack® System.
The FastPack® TSH Calibrator is intended to calibrate the FastPack® System when used for the quantitative determination of TSH in human plasma.
The FastPack ® Controls are assayed quality control materials for the verification of the accuracy and precision of the FastPack® System when used for the quantitative determination of PSA in human serum and plasma, and TSH in human plasma.
The FastPack® TSH Immunoassay is a competitive chemiluminescence assay.
- . Primary incubation: Sample, calibrator, or control (100 uL) is added to the antibody solution (100 uL) to start the sequence. The reaction time is 10 minutes at 37° C.
- . Sccondary incubation: The initial reaction mixture (200 µL) is transferred to the magnetic particles and is incubated an additional 2 minutes at 37° C.
- . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [140 . uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® System at 37° C.
- The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay intended for the in vitro quantitative determination of TSH in human plasma.
Here's a summary describing the acceptance criteria and the study outcomes for the FastPack® TSH Immunoassay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) document compares the FastPack® TSH Immunoassay to a predicate device (Abbott Laboratories IMx Ultrasensitive hTSH II) across several performance characteristics. While explicit "acceptance criteria" are not listed as pass/fail thresholds, the comparison serves as the basis for demonstrating substantial equivalence. The reported performance of the FastPack® TSH Immunoassay is presented alongside the predicate device's performance for direct comparison.
| Feature | Acceptance Criteria (Implied by Predicate) | FastPack® TSH Immunoassay Performance |
|---|---|---|
| Precision | Comparable %CVs to predicate device across different TSH levels (e.g., Run to Run for predicate vs. Between Run for FastPack) | Between Run: |
| 0.53 µIU/mL: 10.9% CV | ||
| 1.54 µIU/mL: 7.4% CV | ||
| 12.39 µIU/mL: 5.2% CV | ||
| Between Analyzer: | ||
| 0.53 µIU/mL: 2.2% CV | ||
| 1.54 µIU/mL: 0.5% CV | ||
| 12.39 µIU/mL: 1.1% CV | ||
| Between Reagent Lot: | ||
| 0.53 µIU/mL: 1.2% CV | ||
| 1.54 µIU/mL: 0.3% CV | ||
| 12.39 µIU/mL: 4.8% CV | ||
| Analytical Sensitivity | Comparable to predicate device (0.02 µIU/mL) | 0.01 µIU/mL |
| Functional Sensitivity | Comparable to predicate device (0.04 µIU/mL) | 0.13 µIU/mL |
| Method Comparison | High correlation (r) and reasonable linear relationship (y=mx+b) to predicate device | n = 93 |
| Range of values (IMx): 0.00 to 75.00 µIU/mL | ||
| Range of values (FastPack): 0.03 to 64.25 µIU/mL | ||
| y = 0.91 x + 1.26 | ||
| r = 0.98 | ||
| Interfering Substances | No interference up to levels comparable to predicate device | Bilirubin: No interference up to 40 mg/dL |
| Hemoglobin: No interference up to 1000 mg/dL | ||
| Triglycerides: No interference up to 1000 mg/dL | ||
| Specificity | n.d. (not detected) for specific interfering hormones at similar or higher concentrations than predicate device | LH: 500 mIU/mL LH (n.d.) |
| FSH: 500 mIU/mL FSH (n.d.) | ||
| hCG: 200,000 mIU/mL hCG (n.d.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Method Comparison): 93 samples were used for the method comparison study against the predicate device.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. However, given the context of a 510(k) submission for an in vitro diagnostic device, it is typically based on samples collected specifically for the performance evaluation, which could include a mix of retrospective and prospectively collected samples from various sources.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the FastPack® TSH Immunoassay is an in vitro diagnostic device that measures a quantitative biomarker (TSH levels). The "ground truth" for such devices is established by reference methods or comparison to legally marketed predicate devices, not through expert reading or interpretation of images/data in the same way as medical imaging AI.
4. Adjudication Method for the Test Set
This is not applicable for a quantitative immunoassay device. The performance is assessed by direct comparison of numerical results to a predicate device or reference method, not by expert adjudication of classifications.
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. This type of study is typically performed for imaging or interpretive diagnostic AI devices where human readers interpret results, and the AI's impact on reader performance is evaluated. The FastPack® TSH Immunoassay is a laboratory assay with an automated result output.
6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the performance data presented (precision, sensitivity, method comparison, interference, specificity) represents the standalone performance of the FastPack® TSH Immunoassay system. This is the inherent performance of the device and its reagents in generating TSH measurements.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the FastPack® TSH Immunoassay was established by comparison to a legally marketed predicate device, the Abbott Laboratories IMx Ultrasensitive hTSH II. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a reference method is not explicitly stated or available. The predicate device's established performance serves as the benchmark.
8. The Sample Size for the Training Set
The document does not report information on a "training set" in the context of machine learning or AI algorithm development. This 510(k) submission describes a traditional immunoassay device, which relies on chemical and biological reactions rather than a trained algorithm in the modern AI sense. Therefore, the concept of a training set as used in AI development is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not applicable to this traditional immunoassay device.
§ 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.